Kerry Dooley Young

Health care providers should be ready to treat rare cases of anaphylaxis following administration of COVID-19 vaccines, federal medical officials have urged. The officials also stressed the importance of continuing vaccinations, despite reports of the rare side effect.

There have been 29 cases of anaphylaxis to date following administration of a COVID-19 vaccine, officials from the Centers for Disease Control and Prevention said in a call with reporters on Jan. 6.

The severe allergic reaction, which appears to be rare, can happen with either the Pfizer-BioNTech vaccine or the rival Moderna product. The Food and Drug Administration granted emergency use authorizations for these two vaccines in December.

Even with the cases seen to date, the COVID-19 vaccines remain a “good value proposition,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization, said in the call.

There have been about 11.1 cases of anaphylaxis per million doses with the Pfizer-BioNTech COVID-19 vaccine, which is higher than the estimated 1.3 cases per million doses with influenza vaccines, she said. But the low risk of anaphylaxis must be balanced against the threat of COVID-19, which currently claims about 2,000 lives a day in the United States, she said. In addition, many people are reporting long-term complications with COVID-19 even if they recover.

Kept in context, the data on anaphylaxis should not scare people away from getting a COVID-19 vaccine, she added.

“Their risk from COVID and poor outcomes is still more than the risk of a severe outcome from the vaccine,” Dr. Messonnier said. “And fortunately, we know how to treat anaphylaxis.”

Dr. Messonnier urged health care workers administering COVID-19 vaccines to be prepared.

“Anybody administering vaccines needs not just to have the EpiPen available, but frankly, to know how to use it,” Dr. Messonnier said.
 

MMWR details

The CDC on Jan. 6 also provided an update on anaphylaxis in Morbidity and Mortality Weekly Report (MMWR).

The information included in the report was based on cases reported with the Pfizer-BioNTech vaccine – the first to get emergency use authorization from the FDA. On the call with reporters, CDC officials confirmed there have been additional reports since then and anaphylaxis has been reported with both the Pfizer-BioNTech and Moderna vaccines. CDC officials said they could not give a breakdown of how many cases were linked to each of these products at this time.

Between Dec. 14 and 23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine. Most reactions – 71% – occurred within 15 minutes of vaccination.

A version of this article first appeared on Medscape.com.

Health care providers should be ready to treat rare cases of anaphylaxis following administration of COVID-19 vaccines, federal medical officials have urged. The officials also stressed the importance of continuing vaccinations, despite reports of the rare side effect.

There have been 29 cases of anaphylaxis to date following administration of a COVID-19 vaccine, officials from the Centers for Disease Control and Prevention said in a call with reporters on Jan. 6.

The severe allergic reaction, which appears to be rare, can happen with either the Pfizer-BioNTech vaccine or the rival Moderna product. The Food and Drug Administration granted emergency use authorizations for these two vaccines in December.

Even with the cases seen to date, the COVID-19 vaccines remain a “good value proposition,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization, said in the call.

There have been about 11.1 cases of anaphylaxis per million doses with the Pfizer-BioNTech COVID-19 vaccine, which is higher than the estimated 1.3 cases per million doses with influenza vaccines, she said. But the low risk of anaphylaxis must be balanced against the threat of COVID-19, which currently claims about 2,000 lives a day in the United States, she said. In addition, many people are reporting long-term complications with COVID-19 even if they recover.

Kept in context, the data on anaphylaxis should not scare people away from getting a COVID-19 vaccine, she added.

“Their risk from COVID and poor outcomes is still more than the risk of a severe outcome from the vaccine,” Dr. Messonnier said. “And fortunately, we know how to treat anaphylaxis.”

Dr. Messonnier urged health care workers administering COVID-19 vaccines to be prepared.

“Anybody administering vaccines needs not just to have the EpiPen available, but frankly, to know how to use it,” Dr. Messonnier said.
 

MMWR details

The CDC on Jan. 6 also provided an update on anaphylaxis in Morbidity and Mortality Weekly Report (MMWR).

The information included in the report was based on cases reported with the Pfizer-BioNTech vaccine – the first to get emergency use authorization from the FDA. On the call with reporters, CDC officials confirmed there have been additional reports since then and anaphylaxis has been reported with both the Pfizer-BioNTech and Moderna vaccines. CDC officials said they could not give a breakdown of how many cases were linked to each of these products at this time.

Between Dec. 14 and 23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine. Most reactions – 71% – occurred within 15 minutes of vaccination.

A version of this article first appeared on Medscape.com.

Health care providers should be ready to treat rare cases of anaphylaxis following administration of COVID-19 vaccines, federal medical officials have urged. The officials also stressed the importance of continuing vaccinations, despite reports of the rare side effect.

There have been 29 cases of anaphylaxis to date following administration of a COVID-19 vaccine, officials from the Centers for Disease Control and Prevention said in a call with reporters on Jan. 6.

The severe allergic reaction, which appears to be rare, can happen with either the Pfizer-BioNTech vaccine or the rival Moderna product. The Food and Drug Administration granted emergency use authorizations for these two vaccines in December.

Even with the cases seen to date, the COVID-19 vaccines remain a “good value proposition,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization, said in the call.

There have been about 11.1 cases of anaphylaxis per million doses with the Pfizer-BioNTech COVID-19 vaccine, which is higher than the estimated 1.3 cases per million doses with influenza vaccines, she said. But the low risk of anaphylaxis must be balanced against the threat of COVID-19, which currently claims about 2,000 lives a day in the United States, she said. In addition, many people are reporting long-term complications with COVID-19 even if they recover.

Kept in context, the data on anaphylaxis should not scare people away from getting a COVID-19 vaccine, she added.

“Their risk from COVID and poor outcomes is still more than the risk of a severe outcome from the vaccine,” Dr. Messonnier said. “And fortunately, we know how to treat anaphylaxis.”

Dr. Messonnier urged health care workers administering COVID-19 vaccines to be prepared.

“Anybody administering vaccines needs not just to have the EpiPen available, but frankly, to know how to use it,” Dr. Messonnier said.
 

MMWR details

The CDC on Jan. 6 also provided an update on anaphylaxis in Morbidity and Mortality Weekly Report (MMWR).

The information included in the report was based on cases reported with the Pfizer-BioNTech vaccine – the first to get emergency use authorization from the FDA. On the call with reporters, CDC officials confirmed there have been additional reports since then and anaphylaxis has been reported with both the Pfizer-BioNTech and Moderna vaccines. CDC officials said they could not give a breakdown of how many cases were linked to each of these products at this time.

Between Dec. 14 and 23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine. Most reactions – 71% – occurred within 15 minutes of vaccination.

A version of this article first appeared on Medscape.com.

Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.

Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.

“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.

Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.

“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
 

Equity issues

Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.

To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.

Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.

That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.

Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.

“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”

The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.

Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.

The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.

There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.

The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.

Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.

“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.

In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.

For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.

Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.

Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.

People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.

“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.

A version of this article first appeared on Medscape.com.

Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.

Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.

“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.

Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.

“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
 

Equity issues

Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.

To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.

Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.

That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.

Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.

“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”

The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.

Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.

The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.

There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.

The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.

Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.

“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.

In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.

For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.

Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.

Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.

People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.

“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.

A version of this article first appeared on Medscape.com.

Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.

Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.

“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.

Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.

“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
 

Equity issues

Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.

To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.

Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.

That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.

Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.

“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”

The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.

Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.

The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.

There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.

The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.

Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.

“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.

In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.

For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.

Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.

Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.

People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.

“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.

A version of this article first appeared on Medscape.com.

An influential federal advisory panel on Dec. 20 voted to recommend that the elderly and certain essential workers be the next group of Americans to get access to limited doses of COVID-19 vaccine.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted 13-1 for the recommendation. This builds on ACIP’s initial recommendation about which groups should be in the first wave of vaccinations, described as Phase 1a.

ACIP earlier recommended that Phase 1a include U.S. health care workers, a group of about 21 million people, and residents of long-term care facilities, a group of about 3 million.

On Dec. 20, ACIP said the next priority group, Phase 1b, should consist of what it called frontline essential workers, a group of about 30 million, and adults aged 75 years and older, a group of about 21 million. When overlap between the groups is taken into account, Phase 1b covers about 49 million people, according to the CDC.

Phase 1c then would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in Phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million.

The Food and Drug Administration recently granted emergency use authorizations for two COVID-19 vaccines, one developed by Pfizer-BioNTech and another from Moderna. Other companies, including Johnson & Johnson, have advanced their potential rival COVID-19 vaccines into late-stages of testing. To date, about 2.83 million doses of Pfizer’s COVID-19 vaccine have been distributed and 556,208 doses have been administered, according to the CDC.

But there will likely still be a period of months when competition for limited doses of COVID-19 vaccine will trigger difficult decisions. Current estimates indicate there will be enough supply to provide COVID-19 vaccines for 20 million people in December, 30 million people in January, and 50 million people in February, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases.

State governments and health systems will take ACIP’s recommendations into account as they roll out the initial supplies of COVID-19 vaccines.

There’s clearly wide latitude in these decisions. Recently, for example, many members of Congress tweeted photos of themselves getting COVID-19 vaccines, despite not falling into ACIP’s description of the Phase 1 group.
 

Difficult choices

All ACIP members described the Dec. 20 vote as a difficult decision. It forced them to choose among segments of the U.S. population that could benefit from early access to the limited supply of COVID-19 vaccines.

“For every group we add, it means we subtract a group. For every group we subtract, it means they don’t get the vaccine” for some months, said ACIP member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn. “It’s incredibly humbling and heartbreaking.”

ACIP member Henry Bernstein, DO, who cast the lone dissenting vote, said he agreed with most of the panel’s recommendation. He said he fully supported the inclusion of adults aged 75 years and older and essential frontline workers in the second wave, Phase 1b. But he voted no because the data on COVID-19 morbidity and mortality for adults aged 65-74 years is similar enough to the older group to warrant their inclusion in the first wave.

“Therefore, inclusion of the 65- to 74-year-old group in Phase 1b made more sense to me,” said Dr. Bernstein, professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in New York.

As defined by the CDC, frontline essential workers included in phase 1b will be those commonly called “first responders,” such as firefighters and police officers. Also in this group are teachers, support staff, daycare providers, and those employed in grocery and agriculture industries. Others in this group would include U.S. Postal Service employees and transit workers.

ACIP panelists noted the difficulties that will emerge as government officials and leaders of health care organizations move to apply their guidance to real-world decisions about distributing a limited supply of COVID-19 vaccine. There’s a potential to worsen existing disparities in access to health care, as people with more income may find it easier to obtain proof that they qualify as having a high-risk condition, said José Romero, MD, the chair of ACIP.

Many people “don’t have access to medical care and can’t come up with a doctor’s note that says, ‘I have diabetes,’ ” he said.

ACIP panelists also noted in their deliberations that people may technically qualify for a priority group but have little risk, such as someone with a chronic medical condition who works from home.

And the risk for COVID-19 remains serious even for those who will ultimately fall into the phase 2 for vaccination. Young adults have suffered serious complications following COVID-19, such as stroke, that may alter their lives dramatically, ACIP member Dr. Talbot said, adding that she is reminded of this in her work.

“We need to be very cautious about saying, ‘Young adults will be fine,’ ” she said. “I spent the past week on back-up clinical call and have read these charts and have cried every day.”

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines. The other panel members have reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

An influential federal advisory panel on Dec. 20 voted to recommend that the elderly and certain essential workers be the next group of Americans to get access to limited doses of COVID-19 vaccine.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted 13-1 for the recommendation. This builds on ACIP’s initial recommendation about which groups should be in the first wave of vaccinations, described as Phase 1a.

ACIP earlier recommended that Phase 1a include U.S. health care workers, a group of about 21 million people, and residents of long-term care facilities, a group of about 3 million.

On Dec. 20, ACIP said the next priority group, Phase 1b, should consist of what it called frontline essential workers, a group of about 30 million, and adults aged 75 years and older, a group of about 21 million. When overlap between the groups is taken into account, Phase 1b covers about 49 million people, according to the CDC.

Phase 1c then would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in Phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million.

The Food and Drug Administration recently granted emergency use authorizations for two COVID-19 vaccines, one developed by Pfizer-BioNTech and another from Moderna. Other companies, including Johnson & Johnson, have advanced their potential rival COVID-19 vaccines into late-stages of testing. To date, about 2.83 million doses of Pfizer’s COVID-19 vaccine have been distributed and 556,208 doses have been administered, according to the CDC.

But there will likely still be a period of months when competition for limited doses of COVID-19 vaccine will trigger difficult decisions. Current estimates indicate there will be enough supply to provide COVID-19 vaccines for 20 million people in December, 30 million people in January, and 50 million people in February, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases.

State governments and health systems will take ACIP’s recommendations into account as they roll out the initial supplies of COVID-19 vaccines.

There’s clearly wide latitude in these decisions. Recently, for example, many members of Congress tweeted photos of themselves getting COVID-19 vaccines, despite not falling into ACIP’s description of the Phase 1 group.
 

Difficult choices

All ACIP members described the Dec. 20 vote as a difficult decision. It forced them to choose among segments of the U.S. population that could benefit from early access to the limited supply of COVID-19 vaccines.

“For every group we add, it means we subtract a group. For every group we subtract, it means they don’t get the vaccine” for some months, said ACIP member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn. “It’s incredibly humbling and heartbreaking.”

ACIP member Henry Bernstein, DO, who cast the lone dissenting vote, said he agreed with most of the panel’s recommendation. He said he fully supported the inclusion of adults aged 75 years and older and essential frontline workers in the second wave, Phase 1b. But he voted no because the data on COVID-19 morbidity and mortality for adults aged 65-74 years is similar enough to the older group to warrant their inclusion in the first wave.

“Therefore, inclusion of the 65- to 74-year-old group in Phase 1b made more sense to me,” said Dr. Bernstein, professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in New York.

As defined by the CDC, frontline essential workers included in phase 1b will be those commonly called “first responders,” such as firefighters and police officers. Also in this group are teachers, support staff, daycare providers, and those employed in grocery and agriculture industries. Others in this group would include U.S. Postal Service employees and transit workers.

ACIP panelists noted the difficulties that will emerge as government officials and leaders of health care organizations move to apply their guidance to real-world decisions about distributing a limited supply of COVID-19 vaccine. There’s a potential to worsen existing disparities in access to health care, as people with more income may find it easier to obtain proof that they qualify as having a high-risk condition, said José Romero, MD, the chair of ACIP.

Many people “don’t have access to medical care and can’t come up with a doctor’s note that says, ‘I have diabetes,’ ” he said.

ACIP panelists also noted in their deliberations that people may technically qualify for a priority group but have little risk, such as someone with a chronic medical condition who works from home.

And the risk for COVID-19 remains serious even for those who will ultimately fall into the phase 2 for vaccination. Young adults have suffered serious complications following COVID-19, such as stroke, that may alter their lives dramatically, ACIP member Dr. Talbot said, adding that she is reminded of this in her work.

“We need to be very cautious about saying, ‘Young adults will be fine,’ ” she said. “I spent the past week on back-up clinical call and have read these charts and have cried every day.”

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines. The other panel members have reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

An influential federal advisory panel on Dec. 20 voted to recommend that the elderly and certain essential workers be the next group of Americans to get access to limited doses of COVID-19 vaccine.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted 13-1 for the recommendation. This builds on ACIP’s initial recommendation about which groups should be in the first wave of vaccinations, described as Phase 1a.

ACIP earlier recommended that Phase 1a include U.S. health care workers, a group of about 21 million people, and residents of long-term care facilities, a group of about 3 million.

On Dec. 20, ACIP said the next priority group, Phase 1b, should consist of what it called frontline essential workers, a group of about 30 million, and adults aged 75 years and older, a group of about 21 million. When overlap between the groups is taken into account, Phase 1b covers about 49 million people, according to the CDC.

Phase 1c then would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in Phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million.

The Food and Drug Administration recently granted emergency use authorizations for two COVID-19 vaccines, one developed by Pfizer-BioNTech and another from Moderna. Other companies, including Johnson & Johnson, have advanced their potential rival COVID-19 vaccines into late-stages of testing. To date, about 2.83 million doses of Pfizer’s COVID-19 vaccine have been distributed and 556,208 doses have been administered, according to the CDC.

But there will likely still be a period of months when competition for limited doses of COVID-19 vaccine will trigger difficult decisions. Current estimates indicate there will be enough supply to provide COVID-19 vaccines for 20 million people in December, 30 million people in January, and 50 million people in February, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases.

State governments and health systems will take ACIP’s recommendations into account as they roll out the initial supplies of COVID-19 vaccines.

There’s clearly wide latitude in these decisions. Recently, for example, many members of Congress tweeted photos of themselves getting COVID-19 vaccines, despite not falling into ACIP’s description of the Phase 1 group.
 

Difficult choices

All ACIP members described the Dec. 20 vote as a difficult decision. It forced them to choose among segments of the U.S. population that could benefit from early access to the limited supply of COVID-19 vaccines.

“For every group we add, it means we subtract a group. For every group we subtract, it means they don’t get the vaccine” for some months, said ACIP member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn. “It’s incredibly humbling and heartbreaking.”

ACIP member Henry Bernstein, DO, who cast the lone dissenting vote, said he agreed with most of the panel’s recommendation. He said he fully supported the inclusion of adults aged 75 years and older and essential frontline workers in the second wave, Phase 1b. But he voted no because the data on COVID-19 morbidity and mortality for adults aged 65-74 years is similar enough to the older group to warrant their inclusion in the first wave.

“Therefore, inclusion of the 65- to 74-year-old group in Phase 1b made more sense to me,” said Dr. Bernstein, professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in New York.

As defined by the CDC, frontline essential workers included in phase 1b will be those commonly called “first responders,” such as firefighters and police officers. Also in this group are teachers, support staff, daycare providers, and those employed in grocery and agriculture industries. Others in this group would include U.S. Postal Service employees and transit workers.

ACIP panelists noted the difficulties that will emerge as government officials and leaders of health care organizations move to apply their guidance to real-world decisions about distributing a limited supply of COVID-19 vaccine. There’s a potential to worsen existing disparities in access to health care, as people with more income may find it easier to obtain proof that they qualify as having a high-risk condition, said José Romero, MD, the chair of ACIP.

Many people “don’t have access to medical care and can’t come up with a doctor’s note that says, ‘I have diabetes,’ ” he said.

ACIP panelists also noted in their deliberations that people may technically qualify for a priority group but have little risk, such as someone with a chronic medical condition who works from home.

And the risk for COVID-19 remains serious even for those who will ultimately fall into the phase 2 for vaccination. Young adults have suffered serious complications following COVID-19, such as stroke, that may alter their lives dramatically, ACIP member Dr. Talbot said, adding that she is reminded of this in her work.

“We need to be very cautious about saying, ‘Young adults will be fine,’ ” she said. “I spent the past week on back-up clinical call and have read these charts and have cried every day.”

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines. The other panel members have reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Moderna’s COVID-19 vaccine — the second now cleared for emergency use in the United States — was endorsed by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) on December 19.

The panel voted 11-0, with three recusals, to recommend use of Moderna’s vaccine for people aged 18 years and older, while seeking more information on risk for anaphylaxis. This vote followed the December 18th decision by the US Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for the vaccine, known as mRNA-1273.

On December 11, the FDA granted the first US emergency clearance for a COVID-19 vaccine to the Pfizer-BioNTech product. ACIP met the following day and voted to endorse the use of that vaccine, with a vote of 11-0 and three recusals. The Pfizer-BioNTech COVID-19 vaccine is recommended for use in people aged 16 years and older.

Moderna’s vaccine is expected to help curb the pandemic, with clinical trial data showing a 94.1% efficacy rate. But there’s also concerns about side effects noted in testing of both vaccines and in the early rollout of the Pfizer vaccine, particularly anaphylaxis.

“There are likely going to be lots of bumps in the road” with the introduction of the COVID-19 vaccines, but these are being disclosed to the public in a way that is “fair and transparent,” said ACIP member Beth P. Bell, MD, MPH.

“Our systems so far appear to be doing what they are supposed to do” in terms of determining risks from the COVID-19 vaccine, added Bell, who is a clinical professor in the department of global health at the University of Washington’s School of Public Health in Seattle. The Moderna EUA  “represents progress towards ending this horrific pandemic,” she said.

In a new forecast released this week, the CDC projects that the number of newly reported COVID-19 deaths will likely increase over the next 4 weeks, with 15,800 to 27,700 new deaths likely to be reported in the week ending January 9, 2021. That could bring the total number of COVID-19 deaths in the United States to between 357,000 and 391,000 by this date, according to the agency.

ACIP panelist Lynn Bahta, RN, MPH, CPH, said she had been “eager” to have the panel proceed with its endorsement of the Moderna vaccine, “especially in light of the fact that we are seeing an average 2600 deaths a day.”

Having two COVID-19 vaccines available might help slow down the pandemic, “despite the fact that we still have a lot to learn both about the disease and the vaccine,” said Bahta, who is an immunization consultant with the Minnesota Department of Health in Saint Paul.

ACIP members encouraged Moderna officials who presented at the meeting to continue studies for potential complications associated with the vaccine when given to women who are pregnant or breastfeeding.

Panelists also pressed for more data on the risk for Bell’s palsy, which the FDA staff also had noted in the agency’s review of Moderna’s vaccine. Moderna has reported four cases from a pivotal study, one in the placebo group and three among study participants who received the company’s vaccine. These cases occurred between 15 and 33 days after vaccination, and are all resolved or resolving, according to Moderna.

There was also a question raised about how many doses of vaccine might be squeezed out of a vial. CDC will explore this topic further at its meeting on COVID-19 vaccines December 20, said Nancy Messonnier, MD, director of the agency’s National Center for Immunization and Respiratory Diseases, at the Saturday meeting.

“In this time of public health crisis, none of us would want to squander a single dose of a vaccine that’s potentially lifesaving,” CDC’s Messonnier said. “We’re going to plan to have a short discussion of that issue tomorrow.”

Messonnier also responded to a comment made during the meeting about cases where people who received COVID-19 vaccine were unaware of the CDC’s V-safe tool.

V-safe is a smartphone-based tool that uses text messaging and web surveys to help people keep in touch with the medical community after getting the COVID-19 vaccine and is seen as a way to help spot side effects. Messonnier asked that people listening to the webcast of the ACIP meeting help spread the word about the CDC’s V-safe tool.

“Our perception, based on the number of people who have enrolled in V-safe, is that the message is getting out to many places, but even one site that doesn’t have this information is something that we want to try to correct,” she said.

Anaphylaxis concerns

The chief concern for ACIP members and CDC staff about COVID-19 vaccines appeared to be reports of allergic reactions. Thomas Clark, MD, MPH, a CDC staff member, told the ACIP panel that, as of December 18, the agency had identified six cases of anaphylaxis following administration of the Pfizer-BioNTech vaccine that met a certain standard, known as the Brighton Collaboration criteria.

Additional case reports have been reviewed and determined not to be anaphylaxis, Clark said. All suspect cases were identified through processes such as the federal Vaccine Adverse Event Reporting System (VAERS), he said.

People who experience anaphylaxis following COVID-19 vaccination should not receive additional doses of the shot, Clark said in his presentation to ACIP. Members of the panel asked Clark whether there have been any discernible patterns to these cases, such as geographic clusters.

Clark replied that it was “early” in the process to make reports, with investigations still ongoing. He did note that the people who had anaphylaxis following vaccination had received their doses from more than one production lot, with multiple lots having been distributed.

“You folks may have seen in the news a couple of cases from Alaska, but we’ve had reports from other jurisdictions so there’s no obvious clustering geographically,” Clark said.

Another CDC staff member, Sarah Mbaeyi, MD, MPH, noted in her presentation that there should be an observation period of 30 minutes following COVID-19 vaccination for anyone with a history of anaphylaxis for any reason, and of at least 15 minutes for other recipients.

Disclosure of ingredients used in the COVID-19 vaccines might help people with an allergy assess these products, the representative for the American Medical Association, Sandra Fryhofer, MD, told ACIP. As such, she thanked CDC’s Mbaeyi for including a breakout of ingredients in her presentation to the panel. Fryhofer encouraged Moderna officials to be as transparent as possible in disclosing the ingredients of the company’s COVID-19 vaccine.

“That might be important because I think it’s very essential that we figure out what might be triggering these anaphylactic reactions, because that is definitely going to affect the vaccine implementation,” Fryhofer said.

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said at the Saturday meeting he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said at the Saturday meeting that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines.

The other panel members have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Moderna’s COVID-19 vaccine — the second now cleared for emergency use in the United States — was endorsed by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) on December 19.

The panel voted 11-0, with three recusals, to recommend use of Moderna’s vaccine for people aged 18 years and older, while seeking more information on risk for anaphylaxis. This vote followed the December 18th decision by the US Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for the vaccine, known as mRNA-1273.

On December 11, the FDA granted the first US emergency clearance for a COVID-19 vaccine to the Pfizer-BioNTech product. ACIP met the following day and voted to endorse the use of that vaccine, with a vote of 11-0 and three recusals. The Pfizer-BioNTech COVID-19 vaccine is recommended for use in people aged 16 years and older.

Moderna’s vaccine is expected to help curb the pandemic, with clinical trial data showing a 94.1% efficacy rate. But there’s also concerns about side effects noted in testing of both vaccines and in the early rollout of the Pfizer vaccine, particularly anaphylaxis.

“There are likely going to be lots of bumps in the road” with the introduction of the COVID-19 vaccines, but these are being disclosed to the public in a way that is “fair and transparent,” said ACIP member Beth P. Bell, MD, MPH.

“Our systems so far appear to be doing what they are supposed to do” in terms of determining risks from the COVID-19 vaccine, added Bell, who is a clinical professor in the department of global health at the University of Washington’s School of Public Health in Seattle. The Moderna EUA  “represents progress towards ending this horrific pandemic,” she said.

In a new forecast released this week, the CDC projects that the number of newly reported COVID-19 deaths will likely increase over the next 4 weeks, with 15,800 to 27,700 new deaths likely to be reported in the week ending January 9, 2021. That could bring the total number of COVID-19 deaths in the United States to between 357,000 and 391,000 by this date, according to the agency.

ACIP panelist Lynn Bahta, RN, MPH, CPH, said she had been “eager” to have the panel proceed with its endorsement of the Moderna vaccine, “especially in light of the fact that we are seeing an average 2600 deaths a day.”

Having two COVID-19 vaccines available might help slow down the pandemic, “despite the fact that we still have a lot to learn both about the disease and the vaccine,” said Bahta, who is an immunization consultant with the Minnesota Department of Health in Saint Paul.

ACIP members encouraged Moderna officials who presented at the meeting to continue studies for potential complications associated with the vaccine when given to women who are pregnant or breastfeeding.

Panelists also pressed for more data on the risk for Bell’s palsy, which the FDA staff also had noted in the agency’s review of Moderna’s vaccine. Moderna has reported four cases from a pivotal study, one in the placebo group and three among study participants who received the company’s vaccine. These cases occurred between 15 and 33 days after vaccination, and are all resolved or resolving, according to Moderna.

There was also a question raised about how many doses of vaccine might be squeezed out of a vial. CDC will explore this topic further at its meeting on COVID-19 vaccines December 20, said Nancy Messonnier, MD, director of the agency’s National Center for Immunization and Respiratory Diseases, at the Saturday meeting.

“In this time of public health crisis, none of us would want to squander a single dose of a vaccine that’s potentially lifesaving,” CDC’s Messonnier said. “We’re going to plan to have a short discussion of that issue tomorrow.”

Messonnier also responded to a comment made during the meeting about cases where people who received COVID-19 vaccine were unaware of the CDC’s V-safe tool.

V-safe is a smartphone-based tool that uses text messaging and web surveys to help people keep in touch with the medical community after getting the COVID-19 vaccine and is seen as a way to help spot side effects. Messonnier asked that people listening to the webcast of the ACIP meeting help spread the word about the CDC’s V-safe tool.

“Our perception, based on the number of people who have enrolled in V-safe, is that the message is getting out to many places, but even one site that doesn’t have this information is something that we want to try to correct,” she said.

Anaphylaxis concerns

The chief concern for ACIP members and CDC staff about COVID-19 vaccines appeared to be reports of allergic reactions. Thomas Clark, MD, MPH, a CDC staff member, told the ACIP panel that, as of December 18, the agency had identified six cases of anaphylaxis following administration of the Pfizer-BioNTech vaccine that met a certain standard, known as the Brighton Collaboration criteria.

Additional case reports have been reviewed and determined not to be anaphylaxis, Clark said. All suspect cases were identified through processes such as the federal Vaccine Adverse Event Reporting System (VAERS), he said.

People who experience anaphylaxis following COVID-19 vaccination should not receive additional doses of the shot, Clark said in his presentation to ACIP. Members of the panel asked Clark whether there have been any discernible patterns to these cases, such as geographic clusters.

Clark replied that it was “early” in the process to make reports, with investigations still ongoing. He did note that the people who had anaphylaxis following vaccination had received their doses from more than one production lot, with multiple lots having been distributed.

“You folks may have seen in the news a couple of cases from Alaska, but we’ve had reports from other jurisdictions so there’s no obvious clustering geographically,” Clark said.

Another CDC staff member, Sarah Mbaeyi, MD, MPH, noted in her presentation that there should be an observation period of 30 minutes following COVID-19 vaccination for anyone with a history of anaphylaxis for any reason, and of at least 15 minutes for other recipients.

Disclosure of ingredients used in the COVID-19 vaccines might help people with an allergy assess these products, the representative for the American Medical Association, Sandra Fryhofer, MD, told ACIP. As such, she thanked CDC’s Mbaeyi for including a breakout of ingredients in her presentation to the panel. Fryhofer encouraged Moderna officials to be as transparent as possible in disclosing the ingredients of the company’s COVID-19 vaccine.

“That might be important because I think it’s very essential that we figure out what might be triggering these anaphylactic reactions, because that is definitely going to affect the vaccine implementation,” Fryhofer said.

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said at the Saturday meeting he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said at the Saturday meeting that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines.

The other panel members have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Moderna’s COVID-19 vaccine — the second now cleared for emergency use in the United States — was endorsed by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) on December 19.

The panel voted 11-0, with three recusals, to recommend use of Moderna’s vaccine for people aged 18 years and older, while seeking more information on risk for anaphylaxis. This vote followed the December 18th decision by the US Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for the vaccine, known as mRNA-1273.

On December 11, the FDA granted the first US emergency clearance for a COVID-19 vaccine to the Pfizer-BioNTech product. ACIP met the following day and voted to endorse the use of that vaccine, with a vote of 11-0 and three recusals. The Pfizer-BioNTech COVID-19 vaccine is recommended for use in people aged 16 years and older.

Moderna’s vaccine is expected to help curb the pandemic, with clinical trial data showing a 94.1% efficacy rate. But there’s also concerns about side effects noted in testing of both vaccines and in the early rollout of the Pfizer vaccine, particularly anaphylaxis.

“There are likely going to be lots of bumps in the road” with the introduction of the COVID-19 vaccines, but these are being disclosed to the public in a way that is “fair and transparent,” said ACIP member Beth P. Bell, MD, MPH.

“Our systems so far appear to be doing what they are supposed to do” in terms of determining risks from the COVID-19 vaccine, added Bell, who is a clinical professor in the department of global health at the University of Washington’s School of Public Health in Seattle. The Moderna EUA  “represents progress towards ending this horrific pandemic,” she said.

In a new forecast released this week, the CDC projects that the number of newly reported COVID-19 deaths will likely increase over the next 4 weeks, with 15,800 to 27,700 new deaths likely to be reported in the week ending January 9, 2021. That could bring the total number of COVID-19 deaths in the United States to between 357,000 and 391,000 by this date, according to the agency.

ACIP panelist Lynn Bahta, RN, MPH, CPH, said she had been “eager” to have the panel proceed with its endorsement of the Moderna vaccine, “especially in light of the fact that we are seeing an average 2600 deaths a day.”

Having two COVID-19 vaccines available might help slow down the pandemic, “despite the fact that we still have a lot to learn both about the disease and the vaccine,” said Bahta, who is an immunization consultant with the Minnesota Department of Health in Saint Paul.

ACIP members encouraged Moderna officials who presented at the meeting to continue studies for potential complications associated with the vaccine when given to women who are pregnant or breastfeeding.

Panelists also pressed for more data on the risk for Bell’s palsy, which the FDA staff also had noted in the agency’s review of Moderna’s vaccine. Moderna has reported four cases from a pivotal study, one in the placebo group and three among study participants who received the company’s vaccine. These cases occurred between 15 and 33 days after vaccination, and are all resolved or resolving, according to Moderna.

There was also a question raised about how many doses of vaccine might be squeezed out of a vial. CDC will explore this topic further at its meeting on COVID-19 vaccines December 20, said Nancy Messonnier, MD, director of the agency’s National Center for Immunization and Respiratory Diseases, at the Saturday meeting.

“In this time of public health crisis, none of us would want to squander a single dose of a vaccine that’s potentially lifesaving,” CDC’s Messonnier said. “We’re going to plan to have a short discussion of that issue tomorrow.”

Messonnier also responded to a comment made during the meeting about cases where people who received COVID-19 vaccine were unaware of the CDC’s V-safe tool.

V-safe is a smartphone-based tool that uses text messaging and web surveys to help people keep in touch with the medical community after getting the COVID-19 vaccine and is seen as a way to help spot side effects. Messonnier asked that people listening to the webcast of the ACIP meeting help spread the word about the CDC’s V-safe tool.

“Our perception, based on the number of people who have enrolled in V-safe, is that the message is getting out to many places, but even one site that doesn’t have this information is something that we want to try to correct,” she said.

Anaphylaxis concerns

The chief concern for ACIP members and CDC staff about COVID-19 vaccines appeared to be reports of allergic reactions. Thomas Clark, MD, MPH, a CDC staff member, told the ACIP panel that, as of December 18, the agency had identified six cases of anaphylaxis following administration of the Pfizer-BioNTech vaccine that met a certain standard, known as the Brighton Collaboration criteria.

Additional case reports have been reviewed and determined not to be anaphylaxis, Clark said. All suspect cases were identified through processes such as the federal Vaccine Adverse Event Reporting System (VAERS), he said.

People who experience anaphylaxis following COVID-19 vaccination should not receive additional doses of the shot, Clark said in his presentation to ACIP. Members of the panel asked Clark whether there have been any discernible patterns to these cases, such as geographic clusters.

Clark replied that it was “early” in the process to make reports, with investigations still ongoing. He did note that the people who had anaphylaxis following vaccination had received their doses from more than one production lot, with multiple lots having been distributed.

“You folks may have seen in the news a couple of cases from Alaska, but we’ve had reports from other jurisdictions so there’s no obvious clustering geographically,” Clark said.

Another CDC staff member, Sarah Mbaeyi, MD, MPH, noted in her presentation that there should be an observation period of 30 minutes following COVID-19 vaccination for anyone with a history of anaphylaxis for any reason, and of at least 15 minutes for other recipients.

Disclosure of ingredients used in the COVID-19 vaccines might help people with an allergy assess these products, the representative for the American Medical Association, Sandra Fryhofer, MD, told ACIP. As such, she thanked CDC’s Mbaeyi for including a breakout of ingredients in her presentation to the panel. Fryhofer encouraged Moderna officials to be as transparent as possible in disclosing the ingredients of the company’s COVID-19 vaccine.

“That might be important because I think it’s very essential that we figure out what might be triggering these anaphylactic reactions, because that is definitely going to affect the vaccine implementation,” Fryhofer said.

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said at the Saturday meeting he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said at the Saturday meeting that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines.

The other panel members have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Federal advisers on December 17 overwhelmingly recommended an emergency clearance to Moderna Inc’s COVID-19 vaccine, while noting concerns about potential allergic reactions and the challenges of continuing testing of this medicine.

The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.

The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.

Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.

FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.

“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”

In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.

Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.

The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.

Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.

In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.

The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.

“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”

mRNA vaccines in the lead

An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.

In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”

“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.

The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.

This article first appeared on Medscape.com.

Federal advisers on December 17 overwhelmingly recommended an emergency clearance to Moderna Inc’s COVID-19 vaccine, while noting concerns about potential allergic reactions and the challenges of continuing testing of this medicine.

The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.

The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.

Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.

FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.

“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”

In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.

Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.

The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.

Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.

In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.

The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.

“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”

mRNA vaccines in the lead

An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.

In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”

“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.

The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.

This article first appeared on Medscape.com.

Federal advisers on December 17 overwhelmingly recommended an emergency clearance to Moderna Inc’s COVID-19 vaccine, while noting concerns about potential allergic reactions and the challenges of continuing testing of this medicine.

The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.

The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.

Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.

FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.

“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”

In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.

Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.

The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.

Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.

In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.

The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.

“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”

mRNA vaccines in the lead

An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.

In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”

“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.

The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.

This article first appeared on Medscape.com.

UPDATED DECEMBER 17

A panel of federal advisers on Tuesday effectively backed a bid to expand approval of sacubitril/valsartan for use in a form of heart failure for which there is not yet an approved medication.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The U.S. Food and Drug Administration asked its Cardiovascular and Renal Drugs Advisory Committee to broadly consider whether new analyses of data from the PARAGON-HF trial, combined with other information, could support use of sacubitril/valsartan (Entresto, Novartis) in heart failure with preserved ejection fraction (HFpEF).

The advisory committee voted 12-1 on this question, which can be seen as a marker for an expanded approval: “Does PARAGON-HF, perhaps supported by previous studies, provide sufficient evidence to support any indication?”

The dissenting vote was cast by the panel’s chairperson, Julia B. Lewis, MD, a professor of medicine from Vanderbilt University. In explaining her vote, Dr. Lewis cited concerns about expanding use of the drug, which has a potential for hypotension. But she noted that the rest of the panelists were “impressed by the totality of the evidence” presented, including a willingness to take a new look at the PARAGON-HF trial. This study was perceived at first pass as having failed to prove a benefit for people with HFpEF.

The 2019 initial unveiling of the PARAGON-HF results had dampened hopes for an evidence-based drug therapy for HFpEF. Patients treated with the first-of-its-kind renin-angiotensin system (RAS) inhibitor, compared with those who received standard valsartan, had 13% fewer heart failure hospitalizations or cardiovascular (CV) deaths over an average of about 3 years, but the difference missed significance at a P value of .059.

“Everybody agreed that the P value of .05 was not written in stone,” Dr. Lewis said in summarizing the panelists’ views on the voting question.

At the FDA’s request, the panel also addressed several other questions without voting on them. The agency asked the panel to describe the patient population for whom an expanded approval would be appropriate. The FDA initially approved sacubitril/valsartan in 2015 to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

Novartis in April submitted an application to the FDA, seeking to expand the use of sacubitril/valsartan from the currently approved indication for the treatment of chronic heart failure (CHF) patients with reduced ejection fraction (HFrEF) to include what the company terms “the adjacent population of patients with preserved ejection fraction (HFpEF) who have a left ventricular ejection fraction (LVEF) below normal.” The American Society of Echocardiography and European Association of Cardiovascular Imaging define normal LVEF and normal range (±2 standard deviations) as 62% (range, 52%-72%) in men and 64% (range, 54%-74%) in women, Novartis said in its briefing materials for the meeting.

FDA panelist Christopher M. O’Connor, MD, for example, suggested that an expanded approval could allow for use of sacubitril/valsartan for the reduction of heart failure or hospitalization in patients with mildly reduced ejection fraction as defined by greater than 45% through 55%. FDA panelist C. Noel Bairey Merz, MD, director of the Barbra Streisand Women’s Heart Center at Cedars-Sinai Medical Center in Los Angeles, suggested extending this to 57% to acknowledge the higher threshold for women.

Another FDA panelist, Steven E. Nissen, MD, of the Cleveland Clinic, argued against use of imprecise terms in defining an expanded patient population for sacubitril/valsartan. If used in the right patient population, the drug could provide a benefit for people who have active heart failure with symptoms, including preventing hospitalizations and renal disease, he said.

“If you are symptomatic with a syndrome that’s consistent with heart failure and you have an ejection fraction below the lower limits of normal, I believe it’s in the public interest for you to get sacubitril/valsartan,” Dr. Nissen said.

The FDA usually follows the advice of its panels, but is not obligated to. But in this case, the agency staff were clearly seeking a path for an expanded approval of sacubitril/valsartan.


 

Challenging a standard

The FDA had encouraged Novartis to submit the supplementary application for the HFpEF indication and even suggested some of the post-hoc analyses, the agency staff said in a briefing document for the meeting.

PARAGON-HF illustrated some of the agency’s concerns about missed opportunities in general in large research trials. Some events of interest in studies may be miscounted due to a lack of information such as a requirement for the presence of physical examination findings that are not documented in the patient’s dossier, the FDA staff said.

“We would like to consider giving ‘partial credit’ to events based on the level of evidence provided, e.g., use of an ordinal variable rather than a dichotomous ‘yes’ or ‘no,’ ” the staff said in the briefing document.

At the panel meeting, Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, told the panelists there is no basis in law for setting a P value of .05 as the benchmark on whether to declare a trial a success or failure.

“I wanted to take a few minutes and make sure that you on the committee understands what flexibility you have in addressing the case study in question,” Dr. Stockbridge said at the start of the meeting.

He then reviewed cases where the FDA had approved claims for cardiac medicines that had not shown desired results in key tests. These include approval of enalapril for use in asymptomatic left ventricular dysfunction on the basis of the SOLVD-Prevention trial, approval of digoxin for heart failure on the basis of the DIG study, and approval of carvedilol for reduced ejection fraction following myocardial infarction on

the basis of the CAPRICORN study, Dr. Stockbridge said.

In reviewing the data for sacubitril/valsartan, FDA staff noted a similarity between investigator-reported and adjudicated results, Stockbridge said.

“This suggested that there were events that did not need all evidentiary criteria as qualified events, but likely were nonetheless,” he said. “This is an example of dichotomization of events being wasteful of information.”

Post-hoc exploratory analyses in PARAGON-HF were able to meet the commonly used standard, according to the FDA briefing document. Among the key findings of these analyses were:

• An analysis of investigator-reported events for the primary composite endpoint of total hospitalizations for heart failure (HHF) and cardiovascular (CV) death demonstrated a rate ratio (RR) of 0.84 (95% confidence interval 0.74- 0.97; P = .01).
• Investigator-reported events added 226 and 290 HHF events but decreased CV death by 56 and 58 events in the sacubitril/valsartan and valsartan arms, respectively. Hence, a net 170 and 232 events were added to the clinical endpoint committee–reported primary composite endpoint leading to a P value of .01, without a significant change in RR.
• Analysis of investigator-reported expanded primary composite endpoint events including total HHF, urgent HF visits, and CV death demonstrated a RR of 0.83 (95% CI, 0.73-0.95; P = .006. There were 136 and 173 investigator-reported urgent HF events in sacubitril/valsartan and valsartan arms, respectively.

Opening a floodgate?

Cynthia L. Chauhan, MSW, of Wichita, Kansas, who served as the consumer representative on the panel, questioned whether a decision to revisit the data on PARAGON-HF might lead drugmakers to seek to repurpose other failed trials.

“Are we opening any kind of floodgate for other researchers to go back and see this is an invitation to try to, for want of a better term, back-door their way into some approvals?” Ms. Chauhan asked.

Dr. Nissen assured her that this concern was valid and would be considered. The goal would be to allow some flexibility in cases that merit further consideration, while preventing companies from data mining until they find some evidence to support an FDA application, he said.

Re-analyzing trials “should be done carefully, conservatively, and only when it really is compelling that the public interest supports it,” Dr. Nissen stressed.

Panelists reported no conflicts of interest related to the topic of the meeting.
 

UPDATED DECEMBER 17

A panel of federal advisers on Tuesday effectively backed a bid to expand approval of sacubitril/valsartan for use in a form of heart failure for which there is not yet an approved medication.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The U.S. Food and Drug Administration asked its Cardiovascular and Renal Drugs Advisory Committee to broadly consider whether new analyses of data from the PARAGON-HF trial, combined with other information, could support use of sacubitril/valsartan (Entresto, Novartis) in heart failure with preserved ejection fraction (HFpEF).

The advisory committee voted 12-1 on this question, which can be seen as a marker for an expanded approval: “Does PARAGON-HF, perhaps supported by previous studies, provide sufficient evidence to support any indication?”

The dissenting vote was cast by the panel’s chairperson, Julia B. Lewis, MD, a professor of medicine from Vanderbilt University. In explaining her vote, Dr. Lewis cited concerns about expanding use of the drug, which has a potential for hypotension. But she noted that the rest of the panelists were “impressed by the totality of the evidence” presented, including a willingness to take a new look at the PARAGON-HF trial. This study was perceived at first pass as having failed to prove a benefit for people with HFpEF.

The 2019 initial unveiling of the PARAGON-HF results had dampened hopes for an evidence-based drug therapy for HFpEF. Patients treated with the first-of-its-kind renin-angiotensin system (RAS) inhibitor, compared with those who received standard valsartan, had 13% fewer heart failure hospitalizations or cardiovascular (CV) deaths over an average of about 3 years, but the difference missed significance at a P value of .059.

“Everybody agreed that the P value of .05 was not written in stone,” Dr. Lewis said in summarizing the panelists’ views on the voting question.

At the FDA’s request, the panel also addressed several other questions without voting on them. The agency asked the panel to describe the patient population for whom an expanded approval would be appropriate. The FDA initially approved sacubitril/valsartan in 2015 to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

Novartis in April submitted an application to the FDA, seeking to expand the use of sacubitril/valsartan from the currently approved indication for the treatment of chronic heart failure (CHF) patients with reduced ejection fraction (HFrEF) to include what the company terms “the adjacent population of patients with preserved ejection fraction (HFpEF) who have a left ventricular ejection fraction (LVEF) below normal.” The American Society of Echocardiography and European Association of Cardiovascular Imaging define normal LVEF and normal range (±2 standard deviations) as 62% (range, 52%-72%) in men and 64% (range, 54%-74%) in women, Novartis said in its briefing materials for the meeting.

FDA panelist Christopher M. O’Connor, MD, for example, suggested that an expanded approval could allow for use of sacubitril/valsartan for the reduction of heart failure or hospitalization in patients with mildly reduced ejection fraction as defined by greater than 45% through 55%. FDA panelist C. Noel Bairey Merz, MD, director of the Barbra Streisand Women’s Heart Center at Cedars-Sinai Medical Center in Los Angeles, suggested extending this to 57% to acknowledge the higher threshold for women.

Another FDA panelist, Steven E. Nissen, MD, of the Cleveland Clinic, argued against use of imprecise terms in defining an expanded patient population for sacubitril/valsartan. If used in the right patient population, the drug could provide a benefit for people who have active heart failure with symptoms, including preventing hospitalizations and renal disease, he said.

“If you are symptomatic with a syndrome that’s consistent with heart failure and you have an ejection fraction below the lower limits of normal, I believe it’s in the public interest for you to get sacubitril/valsartan,” Dr. Nissen said.

The FDA usually follows the advice of its panels, but is not obligated to. But in this case, the agency staff were clearly seeking a path for an expanded approval of sacubitril/valsartan.


 

Challenging a standard

The FDA had encouraged Novartis to submit the supplementary application for the HFpEF indication and even suggested some of the post-hoc analyses, the agency staff said in a briefing document for the meeting.

PARAGON-HF illustrated some of the agency’s concerns about missed opportunities in general in large research trials. Some events of interest in studies may be miscounted due to a lack of information such as a requirement for the presence of physical examination findings that are not documented in the patient’s dossier, the FDA staff said.

“We would like to consider giving ‘partial credit’ to events based on the level of evidence provided, e.g., use of an ordinal variable rather than a dichotomous ‘yes’ or ‘no,’ ” the staff said in the briefing document.

At the panel meeting, Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, told the panelists there is no basis in law for setting a P value of .05 as the benchmark on whether to declare a trial a success or failure.

“I wanted to take a few minutes and make sure that you on the committee understands what flexibility you have in addressing the case study in question,” Dr. Stockbridge said at the start of the meeting.

He then reviewed cases where the FDA had approved claims for cardiac medicines that had not shown desired results in key tests. These include approval of enalapril for use in asymptomatic left ventricular dysfunction on the basis of the SOLVD-Prevention trial, approval of digoxin for heart failure on the basis of the DIG study, and approval of carvedilol for reduced ejection fraction following myocardial infarction on

the basis of the CAPRICORN study, Dr. Stockbridge said.

In reviewing the data for sacubitril/valsartan, FDA staff noted a similarity between investigator-reported and adjudicated results, Stockbridge said.

“This suggested that there were events that did not need all evidentiary criteria as qualified events, but likely were nonetheless,” he said. “This is an example of dichotomization of events being wasteful of information.”

Post-hoc exploratory analyses in PARAGON-HF were able to meet the commonly used standard, according to the FDA briefing document. Among the key findings of these analyses were:

• An analysis of investigator-reported events for the primary composite endpoint of total hospitalizations for heart failure (HHF) and cardiovascular (CV) death demonstrated a rate ratio (RR) of 0.84 (95% confidence interval 0.74- 0.97; P = .01).
• Investigator-reported events added 226 and 290 HHF events but decreased CV death by 56 and 58 events in the sacubitril/valsartan and valsartan arms, respectively. Hence, a net 170 and 232 events were added to the clinical endpoint committee–reported primary composite endpoint leading to a P value of .01, without a significant change in RR.
• Analysis of investigator-reported expanded primary composite endpoint events including total HHF, urgent HF visits, and CV death demonstrated a RR of 0.83 (95% CI, 0.73-0.95; P = .006. There were 136 and 173 investigator-reported urgent HF events in sacubitril/valsartan and valsartan arms, respectively.

Opening a floodgate?

Cynthia L. Chauhan, MSW, of Wichita, Kansas, who served as the consumer representative on the panel, questioned whether a decision to revisit the data on PARAGON-HF might lead drugmakers to seek to repurpose other failed trials.

“Are we opening any kind of floodgate for other researchers to go back and see this is an invitation to try to, for want of a better term, back-door their way into some approvals?” Ms. Chauhan asked.

Dr. Nissen assured her that this concern was valid and would be considered. The goal would be to allow some flexibility in cases that merit further consideration, while preventing companies from data mining until they find some evidence to support an FDA application, he said.

Re-analyzing trials “should be done carefully, conservatively, and only when it really is compelling that the public interest supports it,” Dr. Nissen stressed.

Panelists reported no conflicts of interest related to the topic of the meeting.
 

UPDATED DECEMBER 17

A panel of federal advisers on Tuesday effectively backed a bid to expand approval of sacubitril/valsartan for use in a form of heart failure for which there is not yet an approved medication.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The U.S. Food and Drug Administration asked its Cardiovascular and Renal Drugs Advisory Committee to broadly consider whether new analyses of data from the PARAGON-HF trial, combined with other information, could support use of sacubitril/valsartan (Entresto, Novartis) in heart failure with preserved ejection fraction (HFpEF).

The advisory committee voted 12-1 on this question, which can be seen as a marker for an expanded approval: “Does PARAGON-HF, perhaps supported by previous studies, provide sufficient evidence to support any indication?”

The dissenting vote was cast by the panel’s chairperson, Julia B. Lewis, MD, a professor of medicine from Vanderbilt University. In explaining her vote, Dr. Lewis cited concerns about expanding use of the drug, which has a potential for hypotension. But she noted that the rest of the panelists were “impressed by the totality of the evidence” presented, including a willingness to take a new look at the PARAGON-HF trial. This study was perceived at first pass as having failed to prove a benefit for people with HFpEF.

The 2019 initial unveiling of the PARAGON-HF results had dampened hopes for an evidence-based drug therapy for HFpEF. Patients treated with the first-of-its-kind renin-angiotensin system (RAS) inhibitor, compared with those who received standard valsartan, had 13% fewer heart failure hospitalizations or cardiovascular (CV) deaths over an average of about 3 years, but the difference missed significance at a P value of .059.

“Everybody agreed that the P value of .05 was not written in stone,” Dr. Lewis said in summarizing the panelists’ views on the voting question.

At the FDA’s request, the panel also addressed several other questions without voting on them. The agency asked the panel to describe the patient population for whom an expanded approval would be appropriate. The FDA initially approved sacubitril/valsartan in 2015 to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

Novartis in April submitted an application to the FDA, seeking to expand the use of sacubitril/valsartan from the currently approved indication for the treatment of chronic heart failure (CHF) patients with reduced ejection fraction (HFrEF) to include what the company terms “the adjacent population of patients with preserved ejection fraction (HFpEF) who have a left ventricular ejection fraction (LVEF) below normal.” The American Society of Echocardiography and European Association of Cardiovascular Imaging define normal LVEF and normal range (±2 standard deviations) as 62% (range, 52%-72%) in men and 64% (range, 54%-74%) in women, Novartis said in its briefing materials for the meeting.

FDA panelist Christopher M. O’Connor, MD, for example, suggested that an expanded approval could allow for use of sacubitril/valsartan for the reduction of heart failure or hospitalization in patients with mildly reduced ejection fraction as defined by greater than 45% through 55%. FDA panelist C. Noel Bairey Merz, MD, director of the Barbra Streisand Women’s Heart Center at Cedars-Sinai Medical Center in Los Angeles, suggested extending this to 57% to acknowledge the higher threshold for women.

Another FDA panelist, Steven E. Nissen, MD, of the Cleveland Clinic, argued against use of imprecise terms in defining an expanded patient population for sacubitril/valsartan. If used in the right patient population, the drug could provide a benefit for people who have active heart failure with symptoms, including preventing hospitalizations and renal disease, he said.

“If you are symptomatic with a syndrome that’s consistent with heart failure and you have an ejection fraction below the lower limits of normal, I believe it’s in the public interest for you to get sacubitril/valsartan,” Dr. Nissen said.

The FDA usually follows the advice of its panels, but is not obligated to. But in this case, the agency staff were clearly seeking a path for an expanded approval of sacubitril/valsartan.


 

Challenging a standard

The FDA had encouraged Novartis to submit the supplementary application for the HFpEF indication and even suggested some of the post-hoc analyses, the agency staff said in a briefing document for the meeting.

PARAGON-HF illustrated some of the agency’s concerns about missed opportunities in general in large research trials. Some events of interest in studies may be miscounted due to a lack of information such as a requirement for the presence of physical examination findings that are not documented in the patient’s dossier, the FDA staff said.

“We would like to consider giving ‘partial credit’ to events based on the level of evidence provided, e.g., use of an ordinal variable rather than a dichotomous ‘yes’ or ‘no,’ ” the staff said in the briefing document.

At the panel meeting, Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, told the panelists there is no basis in law for setting a P value of .05 as the benchmark on whether to declare a trial a success or failure.

“I wanted to take a few minutes and make sure that you on the committee understands what flexibility you have in addressing the case study in question,” Dr. Stockbridge said at the start of the meeting.

He then reviewed cases where the FDA had approved claims for cardiac medicines that had not shown desired results in key tests. These include approval of enalapril for use in asymptomatic left ventricular dysfunction on the basis of the SOLVD-Prevention trial, approval of digoxin for heart failure on the basis of the DIG study, and approval of carvedilol for reduced ejection fraction following myocardial infarction on

the basis of the CAPRICORN study, Dr. Stockbridge said.

In reviewing the data for sacubitril/valsartan, FDA staff noted a similarity between investigator-reported and adjudicated results, Stockbridge said.

“This suggested that there were events that did not need all evidentiary criteria as qualified events, but likely were nonetheless,” he said. “This is an example of dichotomization of events being wasteful of information.”

Post-hoc exploratory analyses in PARAGON-HF were able to meet the commonly used standard, according to the FDA briefing document. Among the key findings of these analyses were:

• An analysis of investigator-reported events for the primary composite endpoint of total hospitalizations for heart failure (HHF) and cardiovascular (CV) death demonstrated a rate ratio (RR) of 0.84 (95% confidence interval 0.74- 0.97; P = .01).
• Investigator-reported events added 226 and 290 HHF events but decreased CV death by 56 and 58 events in the sacubitril/valsartan and valsartan arms, respectively. Hence, a net 170 and 232 events were added to the clinical endpoint committee–reported primary composite endpoint leading to a P value of .01, without a significant change in RR.
• Analysis of investigator-reported expanded primary composite endpoint events including total HHF, urgent HF visits, and CV death demonstrated a RR of 0.83 (95% CI, 0.73-0.95; P = .006. There were 136 and 173 investigator-reported urgent HF events in sacubitril/valsartan and valsartan arms, respectively.

Opening a floodgate?

Cynthia L. Chauhan, MSW, of Wichita, Kansas, who served as the consumer representative on the panel, questioned whether a decision to revisit the data on PARAGON-HF might lead drugmakers to seek to repurpose other failed trials.

“Are we opening any kind of floodgate for other researchers to go back and see this is an invitation to try to, for want of a better term, back-door their way into some approvals?” Ms. Chauhan asked.

Dr. Nissen assured her that this concern was valid and would be considered. The goal would be to allow some flexibility in cases that merit further consideration, while preventing companies from data mining until they find some evidence to support an FDA application, he said.

Re-analyzing trials “should be done carefully, conservatively, and only when it really is compelling that the public interest supports it,” Dr. Nissen stressed.

Panelists reported no conflicts of interest related to the topic of the meeting.
 

Federal advisers on Thursday told US regulators that the benefits of Pfizer's COVID vaccine outweigh its risks for people aged 16 years and older, moving this product closer to a special emergency clearance. 

The US Food and Drug Administration (FDA) put Pfizer's application before its Vaccines and Related Biological Products Advisory Committee (VRBPAC), seeking expert feedback on what is likely to be the first COVID-19 vaccine cleared for use in the United States.

New York-based Pfizer is seeking an emergency use authorization (EUA) for its vaccine, known as BNT162b2, which it developed with Germany's BioNTech. The FDA asked its advisers to vote on a single question regarding this product: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?"

The members of VRBPAC voted 17-4 in favor of the Pfizer vaccine, with one panelist abstaining. The FDA considers the recommendations of its panels, but is not bound by them. The agency is expected to quickly grant the special clearance to Pfizer's vaccine, with the company then expected to complete work needed for a more complete biologics license application (BLA).

The FDA often allows members of its advisory committees to explain the reasons for their decisions to vote for or against an application after the tallies are publicly counted.

But the FDA did not give VRBPAC members this opportunity on Thursday, leaving the public without detailed insight into their support or objections.

Before the vote, several panelists had asked if the FDA could rephrase the voting question, raising the age for the approved group to perhaps 18 years of age. During the day, panelists also had questioned whether Pfizer's studies give enough information to judge whether the vaccine works against severe cases of COVID. And there was a discussion about how Pfizer could address concerns about the potential for allergic reactions to the vaccine, given the news of two healthcare workers who experienced allergic reactions after having the vaccine but who have since recovered.

In closing the meeting, VRBPAC chairman, Arnold Monto, MD, noted that the panel will on Dec. 17 meet again to offer recommendations on Moderna Inc.'s COVID vaccine.

"I believe most of us are going to be revisiting some of these issues in about a week," he said.

The panelist who abstained was H. Cody Meissner, MD, an expert in pediatric infectious disease from Tufts University. He earlier was among the several panelists who raised questions about the limited data available about the benefit to those ages 16 and 17. Those voting against the application were Michael Kurilla, MD, PhD; Archana Chatterjee, MD, PhD; A. Oveta Fuller, PhD, and David Kim, MD, MA, according to a tally read by the FDA staff after the vote.

Meanwhile, Sheldon Toubman, JD, voted in favor of the application according to the FDA staff's tally. Toubman had been a chief critic among VRBPAC members in reviewing Pfizer's application at the meeting. He'd suggested limiting the EUA to healthcare workers and residents of nursing homes. Members of these two groups are expected to be the first in the US to get Pfizer's vaccine, for which there will be only a limited initial supply. That idea gained no traction.

Toubman also pressed for more evidence that Pfizer's vaccine will work against severe cases of COVID.

The FDA staff on December 8 released a largely positive agency review of Pfizer vaccine. The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, with eight COVID-19 cases in the vaccine group and 162 COVID-19 cases in the placebo group. The FDA staff said that the 95% credible interval for the vaccine efficacy was 90.3% to 97.6%.

In that review, the FDA staff said there may be a hint from the results observed to date that the Pfizer vaccine may help ward off severe cases of COVID-19. There were 10 study participants that had severe COVID-19 disease after the first dose: one who received the vaccine and nine who received placebo.

"The total number of severe cases is small, which limits the overall conclusions that can be drawn; however, the case split does suggest protection from severe COVID-19 disease," the FDA staff said.

At the meeting today, Doron Fink, MD, PhD, a lead FDA official on the COVID vaccine review, responded directly to Toubman's concerns. There are many examples of vaccines that protect as well if not better against severe disease as they do against mild to moderate disease, Fink said.

"Protecting against disease of any severity is actually a pretty good predictor of protection against severe disease," Fink said, adding that there's already been a "strong result" shown in terms of the efficacy of Pfizer's vaccine.

Rolling out

Canadian health regulators on December 9 announced their nation's conditional approval of Pfizer's vaccine for people ages 16 and older.  In the United Kingdom, a widely publicized rollout of Pfizer's vaccine began on Dec. 8. News quickly spread about two workers in the National Health Service having allergic reactions following vaccination. Both of these workers carry adrenaline autoinjectors, suggesting they have suffered reactions in the past, the Guardian reported. These kinds of autoinjectors are well known in the United States under the brand name EpiPen.

A noted vaccine expert serving on VRBPAC, Paul Offit, MD, of Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, urged the FDA and Pfizer to investigate any connection between reaction to the vaccine and known allergies. If not fully addressed, reports of the reactions seen in initial vaccinations in the UK could prove to unnecessarily frighten people who have allergies away from getting the COVID shot, he said.

Offit suggested running tests where people with egg and peanut allergies would get the Pfizer vaccine under close medical observation "to prove that this is not going to be a problem."

"This is a practical solution because this issue is not going to die until we have better data," Offit said.

More than a dozen COVID-19 vaccines have reached advanced stages of testing, including ones developed in Russia and China, according to the World Health Organization (WHO). The two leading candidates for the US market are the Pfizer/BioNTech vaccine and a similar vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases. Johnson & Johnson and AstraZeneca are among the other companies with COVID-19 vaccines in testing.

The rapid development of COVID vaccines will create challenges in testing these products. A key issue will be how and whether to continue with placebo-controlled trials, even though such research would be helpful, FDA advisers said.

The FDA tasked Steven Goodman, MD, MHS, PhD, of Stanford University with presenting an overview of considerations for continuing a placebo-controlled trial as COVID vaccines become available. Once a COVID-19 vaccine becomes available to the public, people who have received placebo in the Pfizer trial should not be allowed to immediately receive the vaccine, Goodman said.

There isn't a strong medically-based argument against placebo-controlled research in COVID-19, as many people can take steps to reduce their risk for the infection, Goodman said.

"So as long as there are still important things to learn about the vaccine, placebo-controlled trials should not be regarded as unethical," Goodman said. " I think, however, they might be infeasible. And that is a big issue, because people may not be willing to either remain in the study or to enroll."

During the public comment session, a former FDA official spoke of a need for careful consideration of study volunteers' needs in designing trials of COVID-19 vaccines.

"Reasonable people can disagree over whether study subjects should have priority access to a product whose efficacy they helped demonstrate," said Peter Lurie, MD, president of the nonprofit Center for Science in the Public Interest. "But we ought to be able to agree on this: No subject who has put their body on the line in a vaccine study should be at a disadvantage in terms of vaccine access as a result of their participation."

Lurie argued against extended periods of blinded follow-up after authorization of a COVID-19 vaccine. Such a requirement would be "hard to justify ethically, if it is inconsistent with public health recommendations, particularly with rapidly rising case rates and the reported levels of effectiveness" of the Pfizer vaccine, said Lurie, who served as an associate commissioner at FDA from 2014 to 2017.

Lurie also noted the FDA staff's identification of what he called "disproportionate numbers of Bell's Palsy cases (4 in the vaccine groups vs. 0 in the placebo group)" as a matter that should continue to be monitored, including in the postmarketing phase. He raised no objections to the EUA.

Sidney Wolfe, MD, founder and senior adviser to Public Citizen's Health Research Group, also spoke at the public comment session, citing no objection to an EUA for the Pfizer vaccine. Like Lurie, he urged special consideration of people who have or will receive placebo in COVID-19 vaccine trials.

The Thursday advisory committee on the Pfizer vaccine differed from those held for many other products. The discussion focused more on how to monitor and evaluate the vaccine once approved, while advisory committees sometimes include a detailed look at whether a company has proven that its product works. One of the special advisers serving temporarily on VRBPAC, Eric J. Rubin, MD, PhD, also today published an editorial in The New England Journal of Medicine, titled "SARS-CoV-2 Vaccination — An Ounce (Actually, Much Less) of Prevention."

In the editorial, Rubin and coauthor, Dan L. Longo, MD, called the Pfizer vaccine results seen so far "impressive."

"In the primary analysis, only 8 cases of Covid-19 were seen in the vaccine group, as compared with 162 in the placebo group, for an overall efficacy of 95% (with a 95% credible interval of 90.3 to 97.6%)," they write. "Although the trial does not have the statistical power to assess subgroups, efficacy appeared to be similar in low-risk and high-risk persons, including some from communities that have been disproportionately affected by disease, and in participants older than 55 years of age and those younger than 55."

Intense Scrutiny

The FDA has come under intense scrutiny this year in part because of the aggressive — and ultimately unrealistic — timelines for COVID-19 treatments promoted by the Trump administration. President Donald Trump several times suggested a COVID-19 vaccine could be approved before the November election. Many concerned physicians and scientists including Medscape Editor-in-Chief Eric Topol, MD, called on FDA staff to fight back against any bid to inappropriately speed the approval process for political reasons.

"Any shortcuts will not only jeopardize the vaccine programs but betray the public trust, which is already fragile about vaccines, and has been made more so by your lack of autonomy from the Trump administration and its overt politicization of the FDA," Topol wrote in an August open letter to FDA Commissioner Stephen Hahn, MD.

In an October interview with Topol, Hahn noted that there has been some pushback against the idea of an EUA for a COVID-19 vaccine, with some people preferring to wait for a more complete biological license application.

"When you're talking about a pandemic where people are dying, you want to expedite it as much as possible," Hahn told Topol in the interview.

On Thursday, Hahn issued a public statement about the VRBPAC meeting. Hahn said the FDA's "career staff — made up of physicians, biologists, chemists, epidemiologists, statisticians, and other professionals — have been working around the clock to thoroughly evaluate the data and information in the EUA request."

"I can assure you that no vaccine will be authorized for use in the United States until FDA career officials feel confident in allowing their own families to receive it," Hahn said.

Many clinicians offered their views on the FDA meeting during the day on Twitter.

Robert Wachter, MD, chair of the Department of Medicine at the University of California, San Francisco, who has been a vocal opponent of some of Trump's public statements on COVID-19, urged state officials to stick with the FDA's call on the Pfizer vaccine. In a tweet, he noted that officials in California and several other states have called for independent reviews of COVID-19 vaccines.

If such reviews were to delay distribution of vaccines, this would "lead to more harm than good," Wachter tweeted. "Once FDA says 'go', we should go."

This article was updated 12/10/20.

This article originally appeared on Medscape.com.

Federal advisers on Thursday told US regulators that the benefits of Pfizer's COVID vaccine outweigh its risks for people aged 16 years and older, moving this product closer to a special emergency clearance. 

The US Food and Drug Administration (FDA) put Pfizer's application before its Vaccines and Related Biological Products Advisory Committee (VRBPAC), seeking expert feedback on what is likely to be the first COVID-19 vaccine cleared for use in the United States.

New York-based Pfizer is seeking an emergency use authorization (EUA) for its vaccine, known as BNT162b2, which it developed with Germany's BioNTech. The FDA asked its advisers to vote on a single question regarding this product: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?"

The members of VRBPAC voted 17-4 in favor of the Pfizer vaccine, with one panelist abstaining. The FDA considers the recommendations of its panels, but is not bound by them. The agency is expected to quickly grant the special clearance to Pfizer's vaccine, with the company then expected to complete work needed for a more complete biologics license application (BLA).

The FDA often allows members of its advisory committees to explain the reasons for their decisions to vote for or against an application after the tallies are publicly counted.

But the FDA did not give VRBPAC members this opportunity on Thursday, leaving the public without detailed insight into their support or objections.

Before the vote, several panelists had asked if the FDA could rephrase the voting question, raising the age for the approved group to perhaps 18 years of age. During the day, panelists also had questioned whether Pfizer's studies give enough information to judge whether the vaccine works against severe cases of COVID. And there was a discussion about how Pfizer could address concerns about the potential for allergic reactions to the vaccine, given the news of two healthcare workers who experienced allergic reactions after having the vaccine but who have since recovered.

In closing the meeting, VRBPAC chairman, Arnold Monto, MD, noted that the panel will on Dec. 17 meet again to offer recommendations on Moderna Inc.'s COVID vaccine.

"I believe most of us are going to be revisiting some of these issues in about a week," he said.

The panelist who abstained was H. Cody Meissner, MD, an expert in pediatric infectious disease from Tufts University. He earlier was among the several panelists who raised questions about the limited data available about the benefit to those ages 16 and 17. Those voting against the application were Michael Kurilla, MD, PhD; Archana Chatterjee, MD, PhD; A. Oveta Fuller, PhD, and David Kim, MD, MA, according to a tally read by the FDA staff after the vote.

Meanwhile, Sheldon Toubman, JD, voted in favor of the application according to the FDA staff's tally. Toubman had been a chief critic among VRBPAC members in reviewing Pfizer's application at the meeting. He'd suggested limiting the EUA to healthcare workers and residents of nursing homes. Members of these two groups are expected to be the first in the US to get Pfizer's vaccine, for which there will be only a limited initial supply. That idea gained no traction.

Toubman also pressed for more evidence that Pfizer's vaccine will work against severe cases of COVID.

The FDA staff on December 8 released a largely positive agency review of Pfizer vaccine. The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, with eight COVID-19 cases in the vaccine group and 162 COVID-19 cases in the placebo group. The FDA staff said that the 95% credible interval for the vaccine efficacy was 90.3% to 97.6%.

In that review, the FDA staff said there may be a hint from the results observed to date that the Pfizer vaccine may help ward off severe cases of COVID-19. There were 10 study participants that had severe COVID-19 disease after the first dose: one who received the vaccine and nine who received placebo.

"The total number of severe cases is small, which limits the overall conclusions that can be drawn; however, the case split does suggest protection from severe COVID-19 disease," the FDA staff said.

At the meeting today, Doron Fink, MD, PhD, a lead FDA official on the COVID vaccine review, responded directly to Toubman's concerns. There are many examples of vaccines that protect as well if not better against severe disease as they do against mild to moderate disease, Fink said.

"Protecting against disease of any severity is actually a pretty good predictor of protection against severe disease," Fink said, adding that there's already been a "strong result" shown in terms of the efficacy of Pfizer's vaccine.

Rolling out

Canadian health regulators on December 9 announced their nation's conditional approval of Pfizer's vaccine for people ages 16 and older.  In the United Kingdom, a widely publicized rollout of Pfizer's vaccine began on Dec. 8. News quickly spread about two workers in the National Health Service having allergic reactions following vaccination. Both of these workers carry adrenaline autoinjectors, suggesting they have suffered reactions in the past, the Guardian reported. These kinds of autoinjectors are well known in the United States under the brand name EpiPen.

A noted vaccine expert serving on VRBPAC, Paul Offit, MD, of Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, urged the FDA and Pfizer to investigate any connection between reaction to the vaccine and known allergies. If not fully addressed, reports of the reactions seen in initial vaccinations in the UK could prove to unnecessarily frighten people who have allergies away from getting the COVID shot, he said.

Offit suggested running tests where people with egg and peanut allergies would get the Pfizer vaccine under close medical observation "to prove that this is not going to be a problem."

"This is a practical solution because this issue is not going to die until we have better data," Offit said.

More than a dozen COVID-19 vaccines have reached advanced stages of testing, including ones developed in Russia and China, according to the World Health Organization (WHO). The two leading candidates for the US market are the Pfizer/BioNTech vaccine and a similar vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases. Johnson & Johnson and AstraZeneca are among the other companies with COVID-19 vaccines in testing.

The rapid development of COVID vaccines will create challenges in testing these products. A key issue will be how and whether to continue with placebo-controlled trials, even though such research would be helpful, FDA advisers said.

The FDA tasked Steven Goodman, MD, MHS, PhD, of Stanford University with presenting an overview of considerations for continuing a placebo-controlled trial as COVID vaccines become available. Once a COVID-19 vaccine becomes available to the public, people who have received placebo in the Pfizer trial should not be allowed to immediately receive the vaccine, Goodman said.

There isn't a strong medically-based argument against placebo-controlled research in COVID-19, as many people can take steps to reduce their risk for the infection, Goodman said.

"So as long as there are still important things to learn about the vaccine, placebo-controlled trials should not be regarded as unethical," Goodman said. " I think, however, they might be infeasible. And that is a big issue, because people may not be willing to either remain in the study or to enroll."

During the public comment session, a former FDA official spoke of a need for careful consideration of study volunteers' needs in designing trials of COVID-19 vaccines.

"Reasonable people can disagree over whether study subjects should have priority access to a product whose efficacy they helped demonstrate," said Peter Lurie, MD, president of the nonprofit Center for Science in the Public Interest. "But we ought to be able to agree on this: No subject who has put their body on the line in a vaccine study should be at a disadvantage in terms of vaccine access as a result of their participation."

Lurie argued against extended periods of blinded follow-up after authorization of a COVID-19 vaccine. Such a requirement would be "hard to justify ethically, if it is inconsistent with public health recommendations, particularly with rapidly rising case rates and the reported levels of effectiveness" of the Pfizer vaccine, said Lurie, who served as an associate commissioner at FDA from 2014 to 2017.

Lurie also noted the FDA staff's identification of what he called "disproportionate numbers of Bell's Palsy cases (4 in the vaccine groups vs. 0 in the placebo group)" as a matter that should continue to be monitored, including in the postmarketing phase. He raised no objections to the EUA.

Sidney Wolfe, MD, founder and senior adviser to Public Citizen's Health Research Group, also spoke at the public comment session, citing no objection to an EUA for the Pfizer vaccine. Like Lurie, he urged special consideration of people who have or will receive placebo in COVID-19 vaccine trials.

The Thursday advisory committee on the Pfizer vaccine differed from those held for many other products. The discussion focused more on how to monitor and evaluate the vaccine once approved, while advisory committees sometimes include a detailed look at whether a company has proven that its product works. One of the special advisers serving temporarily on VRBPAC, Eric J. Rubin, MD, PhD, also today published an editorial in The New England Journal of Medicine, titled "SARS-CoV-2 Vaccination — An Ounce (Actually, Much Less) of Prevention."

In the editorial, Rubin and coauthor, Dan L. Longo, MD, called the Pfizer vaccine results seen so far "impressive."

"In the primary analysis, only 8 cases of Covid-19 were seen in the vaccine group, as compared with 162 in the placebo group, for an overall efficacy of 95% (with a 95% credible interval of 90.3 to 97.6%)," they write. "Although the trial does not have the statistical power to assess subgroups, efficacy appeared to be similar in low-risk and high-risk persons, including some from communities that have been disproportionately affected by disease, and in participants older than 55 years of age and those younger than 55."

Intense Scrutiny

The FDA has come under intense scrutiny this year in part because of the aggressive — and ultimately unrealistic — timelines for COVID-19 treatments promoted by the Trump administration. President Donald Trump several times suggested a COVID-19 vaccine could be approved before the November election. Many concerned physicians and scientists including Medscape Editor-in-Chief Eric Topol, MD, called on FDA staff to fight back against any bid to inappropriately speed the approval process for political reasons.

"Any shortcuts will not only jeopardize the vaccine programs but betray the public trust, which is already fragile about vaccines, and has been made more so by your lack of autonomy from the Trump administration and its overt politicization of the FDA," Topol wrote in an August open letter to FDA Commissioner Stephen Hahn, MD.

In an October interview with Topol, Hahn noted that there has been some pushback against the idea of an EUA for a COVID-19 vaccine, with some people preferring to wait for a more complete biological license application.

"When you're talking about a pandemic where people are dying, you want to expedite it as much as possible," Hahn told Topol in the interview.

On Thursday, Hahn issued a public statement about the VRBPAC meeting. Hahn said the FDA's "career staff — made up of physicians, biologists, chemists, epidemiologists, statisticians, and other professionals — have been working around the clock to thoroughly evaluate the data and information in the EUA request."

"I can assure you that no vaccine will be authorized for use in the United States until FDA career officials feel confident in allowing their own families to receive it," Hahn said.

Many clinicians offered their views on the FDA meeting during the day on Twitter.

Robert Wachter, MD, chair of the Department of Medicine at the University of California, San Francisco, who has been a vocal opponent of some of Trump's public statements on COVID-19, urged state officials to stick with the FDA's call on the Pfizer vaccine. In a tweet, he noted that officials in California and several other states have called for independent reviews of COVID-19 vaccines.

If such reviews were to delay distribution of vaccines, this would "lead to more harm than good," Wachter tweeted. "Once FDA says 'go', we should go."

This article was updated 12/10/20.

This article originally appeared on Medscape.com.

Federal advisers on Thursday told US regulators that the benefits of Pfizer's COVID vaccine outweigh its risks for people aged 16 years and older, moving this product closer to a special emergency clearance. 

The US Food and Drug Administration (FDA) put Pfizer's application before its Vaccines and Related Biological Products Advisory Committee (VRBPAC), seeking expert feedback on what is likely to be the first COVID-19 vaccine cleared for use in the United States.

New York-based Pfizer is seeking an emergency use authorization (EUA) for its vaccine, known as BNT162b2, which it developed with Germany's BioNTech. The FDA asked its advisers to vote on a single question regarding this product: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?"

The members of VRBPAC voted 17-4 in favor of the Pfizer vaccine, with one panelist abstaining. The FDA considers the recommendations of its panels, but is not bound by them. The agency is expected to quickly grant the special clearance to Pfizer's vaccine, with the company then expected to complete work needed for a more complete biologics license application (BLA).

The FDA often allows members of its advisory committees to explain the reasons for their decisions to vote for or against an application after the tallies are publicly counted.

But the FDA did not give VRBPAC members this opportunity on Thursday, leaving the public without detailed insight into their support or objections.

Before the vote, several panelists had asked if the FDA could rephrase the voting question, raising the age for the approved group to perhaps 18 years of age. During the day, panelists also had questioned whether Pfizer's studies give enough information to judge whether the vaccine works against severe cases of COVID. And there was a discussion about how Pfizer could address concerns about the potential for allergic reactions to the vaccine, given the news of two healthcare workers who experienced allergic reactions after having the vaccine but who have since recovered.

In closing the meeting, VRBPAC chairman, Arnold Monto, MD, noted that the panel will on Dec. 17 meet again to offer recommendations on Moderna Inc.'s COVID vaccine.

"I believe most of us are going to be revisiting some of these issues in about a week," he said.

The panelist who abstained was H. Cody Meissner, MD, an expert in pediatric infectious disease from Tufts University. He earlier was among the several panelists who raised questions about the limited data available about the benefit to those ages 16 and 17. Those voting against the application were Michael Kurilla, MD, PhD; Archana Chatterjee, MD, PhD; A. Oveta Fuller, PhD, and David Kim, MD, MA, according to a tally read by the FDA staff after the vote.

Meanwhile, Sheldon Toubman, JD, voted in favor of the application according to the FDA staff's tally. Toubman had been a chief critic among VRBPAC members in reviewing Pfizer's application at the meeting. He'd suggested limiting the EUA to healthcare workers and residents of nursing homes. Members of these two groups are expected to be the first in the US to get Pfizer's vaccine, for which there will be only a limited initial supply. That idea gained no traction.

Toubman also pressed for more evidence that Pfizer's vaccine will work against severe cases of COVID.

The FDA staff on December 8 released a largely positive agency review of Pfizer vaccine. The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, with eight COVID-19 cases in the vaccine group and 162 COVID-19 cases in the placebo group. The FDA staff said that the 95% credible interval for the vaccine efficacy was 90.3% to 97.6%.

In that review, the FDA staff said there may be a hint from the results observed to date that the Pfizer vaccine may help ward off severe cases of COVID-19. There were 10 study participants that had severe COVID-19 disease after the first dose: one who received the vaccine and nine who received placebo.

"The total number of severe cases is small, which limits the overall conclusions that can be drawn; however, the case split does suggest protection from severe COVID-19 disease," the FDA staff said.

At the meeting today, Doron Fink, MD, PhD, a lead FDA official on the COVID vaccine review, responded directly to Toubman's concerns. There are many examples of vaccines that protect as well if not better against severe disease as they do against mild to moderate disease, Fink said.

"Protecting against disease of any severity is actually a pretty good predictor of protection against severe disease," Fink said, adding that there's already been a "strong result" shown in terms of the efficacy of Pfizer's vaccine.

Rolling out

Canadian health regulators on December 9 announced their nation's conditional approval of Pfizer's vaccine for people ages 16 and older.  In the United Kingdom, a widely publicized rollout of Pfizer's vaccine began on Dec. 8. News quickly spread about two workers in the National Health Service having allergic reactions following vaccination. Both of these workers carry adrenaline autoinjectors, suggesting they have suffered reactions in the past, the Guardian reported. These kinds of autoinjectors are well known in the United States under the brand name EpiPen.

A noted vaccine expert serving on VRBPAC, Paul Offit, MD, of Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, urged the FDA and Pfizer to investigate any connection between reaction to the vaccine and known allergies. If not fully addressed, reports of the reactions seen in initial vaccinations in the UK could prove to unnecessarily frighten people who have allergies away from getting the COVID shot, he said.

Offit suggested running tests where people with egg and peanut allergies would get the Pfizer vaccine under close medical observation "to prove that this is not going to be a problem."

"This is a practical solution because this issue is not going to die until we have better data," Offit said.

More than a dozen COVID-19 vaccines have reached advanced stages of testing, including ones developed in Russia and China, according to the World Health Organization (WHO). The two leading candidates for the US market are the Pfizer/BioNTech vaccine and a similar vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases. Johnson & Johnson and AstraZeneca are among the other companies with COVID-19 vaccines in testing.

The rapid development of COVID vaccines will create challenges in testing these products. A key issue will be how and whether to continue with placebo-controlled trials, even though such research would be helpful, FDA advisers said.

The FDA tasked Steven Goodman, MD, MHS, PhD, of Stanford University with presenting an overview of considerations for continuing a placebo-controlled trial as COVID vaccines become available. Once a COVID-19 vaccine becomes available to the public, people who have received placebo in the Pfizer trial should not be allowed to immediately receive the vaccine, Goodman said.

There isn't a strong medically-based argument against placebo-controlled research in COVID-19, as many people can take steps to reduce their risk for the infection, Goodman said.

"So as long as there are still important things to learn about the vaccine, placebo-controlled trials should not be regarded as unethical," Goodman said. " I think, however, they might be infeasible. And that is a big issue, because people may not be willing to either remain in the study or to enroll."

During the public comment session, a former FDA official spoke of a need for careful consideration of study volunteers' needs in designing trials of COVID-19 vaccines.

"Reasonable people can disagree over whether study subjects should have priority access to a product whose efficacy they helped demonstrate," said Peter Lurie, MD, president of the nonprofit Center for Science in the Public Interest. "But we ought to be able to agree on this: No subject who has put their body on the line in a vaccine study should be at a disadvantage in terms of vaccine access as a result of their participation."

Lurie argued against extended periods of blinded follow-up after authorization of a COVID-19 vaccine. Such a requirement would be "hard to justify ethically, if it is inconsistent with public health recommendations, particularly with rapidly rising case rates and the reported levels of effectiveness" of the Pfizer vaccine, said Lurie, who served as an associate commissioner at FDA from 2014 to 2017.

Lurie also noted the FDA staff's identification of what he called "disproportionate numbers of Bell's Palsy cases (4 in the vaccine groups vs. 0 in the placebo group)" as a matter that should continue to be monitored, including in the postmarketing phase. He raised no objections to the EUA.

Sidney Wolfe, MD, founder and senior adviser to Public Citizen's Health Research Group, also spoke at the public comment session, citing no objection to an EUA for the Pfizer vaccine. Like Lurie, he urged special consideration of people who have or will receive placebo in COVID-19 vaccine trials.

The Thursday advisory committee on the Pfizer vaccine differed from those held for many other products. The discussion focused more on how to monitor and evaluate the vaccine once approved, while advisory committees sometimes include a detailed look at whether a company has proven that its product works. One of the special advisers serving temporarily on VRBPAC, Eric J. Rubin, MD, PhD, also today published an editorial in The New England Journal of Medicine, titled "SARS-CoV-2 Vaccination — An Ounce (Actually, Much Less) of Prevention."

In the editorial, Rubin and coauthor, Dan L. Longo, MD, called the Pfizer vaccine results seen so far "impressive."

"In the primary analysis, only 8 cases of Covid-19 were seen in the vaccine group, as compared with 162 in the placebo group, for an overall efficacy of 95% (with a 95% credible interval of 90.3 to 97.6%)," they write. "Although the trial does not have the statistical power to assess subgroups, efficacy appeared to be similar in low-risk and high-risk persons, including some from communities that have been disproportionately affected by disease, and in participants older than 55 years of age and those younger than 55."

Intense Scrutiny

The FDA has come under intense scrutiny this year in part because of the aggressive — and ultimately unrealistic — timelines for COVID-19 treatments promoted by the Trump administration. President Donald Trump several times suggested a COVID-19 vaccine could be approved before the November election. Many concerned physicians and scientists including Medscape Editor-in-Chief Eric Topol, MD, called on FDA staff to fight back against any bid to inappropriately speed the approval process for political reasons.

"Any shortcuts will not only jeopardize the vaccine programs but betray the public trust, which is already fragile about vaccines, and has been made more so by your lack of autonomy from the Trump administration and its overt politicization of the FDA," Topol wrote in an August open letter to FDA Commissioner Stephen Hahn, MD.

In an October interview with Topol, Hahn noted that there has been some pushback against the idea of an EUA for a COVID-19 vaccine, with some people preferring to wait for a more complete biological license application.

"When you're talking about a pandemic where people are dying, you want to expedite it as much as possible," Hahn told Topol in the interview.

On Thursday, Hahn issued a public statement about the VRBPAC meeting. Hahn said the FDA's "career staff — made up of physicians, biologists, chemists, epidemiologists, statisticians, and other professionals — have been working around the clock to thoroughly evaluate the data and information in the EUA request."

"I can assure you that no vaccine will be authorized for use in the United States until FDA career officials feel confident in allowing their own families to receive it," Hahn said.

Many clinicians offered their views on the FDA meeting during the day on Twitter.

Robert Wachter, MD, chair of the Department of Medicine at the University of California, San Francisco, who has been a vocal opponent of some of Trump's public statements on COVID-19, urged state officials to stick with the FDA's call on the Pfizer vaccine. In a tweet, he noted that officials in California and several other states have called for independent reviews of COVID-19 vaccines.

If such reviews were to delay distribution of vaccines, this would "lead to more harm than good," Wachter tweeted. "Once FDA says 'go', we should go."

This article was updated 12/10/20.

This article originally appeared on Medscape.com.

Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule will take effect within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%).

CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.

The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.

In a Tuesday statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”

By AMA’s calculations, CMS’ planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Bailey said will result in “simpler and more flexible” coding and documentation.

The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.

In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on January 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020.

The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.

Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement on Tuesday, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.

“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
 

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a Tuesday tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a November 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

A version of this article originally appeared on Medscape.com.

Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule will take effect within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%).

CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.

The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.

In a Tuesday statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”

By AMA’s calculations, CMS’ planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Bailey said will result in “simpler and more flexible” coding and documentation.

The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.

In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on January 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020.

The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.

Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement on Tuesday, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.

“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
 

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a Tuesday tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a November 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

A version of this article originally appeared on Medscape.com.

Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule will take effect within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%).

CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.

The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.

In a Tuesday statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”

By AMA’s calculations, CMS’ planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Bailey said will result in “simpler and more flexible” coding and documentation.

The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.

In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on January 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020.

The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.

Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement on Tuesday, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.

“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
 

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a Tuesday tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a November 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

A version of this article originally appeared on Medscape.com.

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.

The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

A version of this article originally appeared on Medscape.com.

The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

A version of this article originally appeared on Medscape.com.

The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

A version of this article originally appeared on Medscape.com.