MDedge Infectious Disease

“I want my child to go back to school,” the mother said to me. “I just want you to tell me it will be safe.”

As the summer break winds down for children across the United States, pediatric COVID-19 cases are rising. According to the American Academy of Pediatrics, nearly 94,000 cases were reported for the week ending Aug. 5, more than double the case count from 2 weeks earlier.¹

Anecdotally, some children’s hospitals are reporting an increase in pediatric COVID-19 admissions. In the hospital in which I practice, we are seeing numbers similar to those we saw in December and January: a typical daily census of 10 kids admitted with COVID-19, with 4 of them in the intensive care unit. It is a stark contrast to June when, most days, we had no patients with COVID-19 in the hospital. About half of our hospitalized patients are too young to be vaccinated against COVID-19, while the rest are unvaccinated children 12 years and older.

Vaccination of eligible children and teachers is an essential strategy for preventing the spread of COVID-19 in schools, but as children head back to school, immunization rates of educators are largely unknown and are suboptimal among students in most states. As of Aug. 11, 10.7 million U.S. children had received at least one dose of COVID-19 vaccine, representing 43% of 12- to 15-year-olds and 53% of 16- to 17-year-olds.² Rates vary substantially by state, with more than 70% of kids in Vermont receiving at least one dose of vaccine, compared with less than 25% in Wyoming and Alabama.

Still, in the absence of robust immunization rates, we have data that schools can still reopen successfully. We need to follow the science and implement universal masking, a safe, effective, and practical mitigation strategy.

It worked in Wisconsin. Seventeen K-12 schools in rural Wisconsin opened last fall for in-person instruction.³ Reported compliance with masking was high, ranging from 92.1% to 97.4%, and in-school transmission of COVID-19 was low, with seven cases among 4,876 students.

It worked in Salt Lake City.⁴ In 20 elementary schools open for in-person instruction Dec. 3, 2020, to Jan. 31, 2021, compliance with mask-wearing was high and in-school transmission was very low, despite a high community incidence of COVID-19. Notably, students’ classroom seats were less than 6 feet apart, suggesting that consistent mask-wearing works even when physical distancing is challenging.

One of the best examples of successful school reopening happened in North Carolina, where pediatricians, pediatric infectious disease specialists, and other experts affiliated with Duke University formed the ABC Science Collaborative to support school districts that requested scientific input to help guide return-to-school policies during the COVID-19 pandemic. From Oct. 26, 2020, to Feb. 28, 2021, the ABC Science Collaborative worked with 13 school districts that were open for in-person instruction using basic mitigation strategies, including universal masking.⁵ During this time period, there were 4,969 community-acquired SARS-CoV-2 infections in the more than 100,000 students and staff present in schools. Transmission to school contacts was identified in only 209 individuals for a secondary attack rate of less than 1%.

Duke investigator Kanecia Zimmerman, MD, told Duke Today, “We know that, if our goal is to reduce transmission of COVID-19 in schools, there are two effective ways to do that: 1. vaccination, 2. masking. In the setting of schools ... the science suggests masking can be extremely effective, particularly for those who can’t get vaccinated while COVID-19 is still circulating.”

Both the AAP⁶ and the Pediatric Infectious Diseases Society⁷ have emphasized the importance of in-person instruction and endorsed universal masking in school. Mask-optional policies or “mask-if-you-are-unvaccinated” policies don’t work, as we have seen in society at large. They are likely to be especially challenging in school settings. Given an option, many, if not most kids, will take off their masks. Kids who leave them on run the risk of stigmatization or bullying.

On Aug. 4, the Centers for Disease Control and Prevention updated its guidance to recommend universal indoor masking for all students, staff, teachers, and visitors to K-12 schools, regardless of vaccination status. Now we’ll have to wait and see if school districts, elected officials, and parents will get on board with masks. ... and we’ll be left to count the number of rising COVID-19 cases that occur until they do.

Case in point: Kids in Greater Clark County, Ind., headed back to school on July 28. Masks were not required on school property, although unvaccinated students and teachers were “strongly encouraged” to wear them.⁸

Over the first 8 days of in-person instruction, schools in Greater Clark County identified 70 cases of COVID-19 in students and quarantined more than 1,100 of the district’s 10,300 students. Only the unvaccinated were required to quarantine. The district began requiring masks in all school buildings on Aug. 9.⁹

The worried mother had one last question for me. “What’s the best mask for a child to wear?” For most kids, a simple, well-fitting cloth mask is fine. The best mask is ultimately the mask a child will wear. A toolkit with practical tips for helping children successfully wear a mask is available on the ABC Science Collaborative website.
 

Dr. Bryant, president of the Pediatric Infectious Diseases Society, is a pediatrician at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. American Academy of Pediatrics. “Children and COVID-19: State-level data report.”

2. American Academy of Pediatrics. “Children and COVID-19 vaccination trends.”

3. Falk A et al. MMWR Morb Mortal Wkly Rep. 2021;70:136-40.

4. Hershow RB et al. MMWR Morb Mortal Wkly Rep 2021;70:442-8.

5. Zimmerman KO et al. Pediatrics. 2021 Jul;e2021052686. doi: 10.1542/peds.2021-052686.

6. American Academy of Pediatrics. “American Academy of Pediatrics updates recommendations for opening schools in fall 2021.”

7. Pediatric Infectious Diseases Society. “PIDS supports universal masking for students, school staff.”

8. Courtney Hayden. WHAS11. “Greater Clark County Schools return to class July 28.”

9. Dustin Vogt. WAVE3 News. “Greater Clark Country Schools to require masks amid 70 positive cases.”

“I want my child to go back to school,” the mother said to me. “I just want you to tell me it will be safe.”

As the summer break winds down for children across the United States, pediatric COVID-19 cases are rising. According to the American Academy of Pediatrics, nearly 94,000 cases were reported for the week ending Aug. 5, more than double the case count from 2 weeks earlier.¹

Anecdotally, some children’s hospitals are reporting an increase in pediatric COVID-19 admissions. In the hospital in which I practice, we are seeing numbers similar to those we saw in December and January: a typical daily census of 10 kids admitted with COVID-19, with 4 of them in the intensive care unit. It is a stark contrast to June when, most days, we had no patients with COVID-19 in the hospital. About half of our hospitalized patients are too young to be vaccinated against COVID-19, while the rest are unvaccinated children 12 years and older.

Vaccination of eligible children and teachers is an essential strategy for preventing the spread of COVID-19 in schools, but as children head back to school, immunization rates of educators are largely unknown and are suboptimal among students in most states. As of Aug. 11, 10.7 million U.S. children had received at least one dose of COVID-19 vaccine, representing 43% of 12- to 15-year-olds and 53% of 16- to 17-year-olds.² Rates vary substantially by state, with more than 70% of kids in Vermont receiving at least one dose of vaccine, compared with less than 25% in Wyoming and Alabama.

Still, in the absence of robust immunization rates, we have data that schools can still reopen successfully. We need to follow the science and implement universal masking, a safe, effective, and practical mitigation strategy.

It worked in Wisconsin. Seventeen K-12 schools in rural Wisconsin opened last fall for in-person instruction.³ Reported compliance with masking was high, ranging from 92.1% to 97.4%, and in-school transmission of COVID-19 was low, with seven cases among 4,876 students.

It worked in Salt Lake City.⁴ In 20 elementary schools open for in-person instruction Dec. 3, 2020, to Jan. 31, 2021, compliance with mask-wearing was high and in-school transmission was very low, despite a high community incidence of COVID-19. Notably, students’ classroom seats were less than 6 feet apart, suggesting that consistent mask-wearing works even when physical distancing is challenging.

One of the best examples of successful school reopening happened in North Carolina, where pediatricians, pediatric infectious disease specialists, and other experts affiliated with Duke University formed the ABC Science Collaborative to support school districts that requested scientific input to help guide return-to-school policies during the COVID-19 pandemic. From Oct. 26, 2020, to Feb. 28, 2021, the ABC Science Collaborative worked with 13 school districts that were open for in-person instruction using basic mitigation strategies, including universal masking.⁵ During this time period, there were 4,969 community-acquired SARS-CoV-2 infections in the more than 100,000 students and staff present in schools. Transmission to school contacts was identified in only 209 individuals for a secondary attack rate of less than 1%.

Duke investigator Kanecia Zimmerman, MD, told Duke Today, “We know that, if our goal is to reduce transmission of COVID-19 in schools, there are two effective ways to do that: 1. vaccination, 2. masking. In the setting of schools ... the science suggests masking can be extremely effective, particularly for those who can’t get vaccinated while COVID-19 is still circulating.”

Both the AAP⁶ and the Pediatric Infectious Diseases Society⁷ have emphasized the importance of in-person instruction and endorsed universal masking in school. Mask-optional policies or “mask-if-you-are-unvaccinated” policies don’t work, as we have seen in society at large. They are likely to be especially challenging in school settings. Given an option, many, if not most kids, will take off their masks. Kids who leave them on run the risk of stigmatization or bullying.

On Aug. 4, the Centers for Disease Control and Prevention updated its guidance to recommend universal indoor masking for all students, staff, teachers, and visitors to K-12 schools, regardless of vaccination status. Now we’ll have to wait and see if school districts, elected officials, and parents will get on board with masks. ... and we’ll be left to count the number of rising COVID-19 cases that occur until they do.

Case in point: Kids in Greater Clark County, Ind., headed back to school on July 28. Masks were not required on school property, although unvaccinated students and teachers were “strongly encouraged” to wear them.⁸

Over the first 8 days of in-person instruction, schools in Greater Clark County identified 70 cases of COVID-19 in students and quarantined more than 1,100 of the district’s 10,300 students. Only the unvaccinated were required to quarantine. The district began requiring masks in all school buildings on Aug. 9.⁹

The worried mother had one last question for me. “What’s the best mask for a child to wear?” For most kids, a simple, well-fitting cloth mask is fine. The best mask is ultimately the mask a child will wear. A toolkit with practical tips for helping children successfully wear a mask is available on the ABC Science Collaborative website.
 

Dr. Bryant, president of the Pediatric Infectious Diseases Society, is a pediatrician at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. American Academy of Pediatrics. “Children and COVID-19: State-level data report.”

2. American Academy of Pediatrics. “Children and COVID-19 vaccination trends.”

3. Falk A et al. MMWR Morb Mortal Wkly Rep. 2021;70:136-40.

4. Hershow RB et al. MMWR Morb Mortal Wkly Rep 2021;70:442-8.

5. Zimmerman KO et al. Pediatrics. 2021 Jul;e2021052686. doi: 10.1542/peds.2021-052686.

6. American Academy of Pediatrics. “American Academy of Pediatrics updates recommendations for opening schools in fall 2021.”

7. Pediatric Infectious Diseases Society. “PIDS supports universal masking for students, school staff.”

8. Courtney Hayden. WHAS11. “Greater Clark County Schools return to class July 28.”

9. Dustin Vogt. WAVE3 News. “Greater Clark Country Schools to require masks amid 70 positive cases.”

“I want my child to go back to school,” the mother said to me. “I just want you to tell me it will be safe.”

As the summer break winds down for children across the United States, pediatric COVID-19 cases are rising. According to the American Academy of Pediatrics, nearly 94,000 cases were reported for the week ending Aug. 5, more than double the case count from 2 weeks earlier.¹

Anecdotally, some children’s hospitals are reporting an increase in pediatric COVID-19 admissions. In the hospital in which I practice, we are seeing numbers similar to those we saw in December and January: a typical daily census of 10 kids admitted with COVID-19, with 4 of them in the intensive care unit. It is a stark contrast to June when, most days, we had no patients with COVID-19 in the hospital. About half of our hospitalized patients are too young to be vaccinated against COVID-19, while the rest are unvaccinated children 12 years and older.

Vaccination of eligible children and teachers is an essential strategy for preventing the spread of COVID-19 in schools, but as children head back to school, immunization rates of educators are largely unknown and are suboptimal among students in most states. As of Aug. 11, 10.7 million U.S. children had received at least one dose of COVID-19 vaccine, representing 43% of 12- to 15-year-olds and 53% of 16- to 17-year-olds.² Rates vary substantially by state, with more than 70% of kids in Vermont receiving at least one dose of vaccine, compared with less than 25% in Wyoming and Alabama.

Still, in the absence of robust immunization rates, we have data that schools can still reopen successfully. We need to follow the science and implement universal masking, a safe, effective, and practical mitigation strategy.

It worked in Wisconsin. Seventeen K-12 schools in rural Wisconsin opened last fall for in-person instruction.³ Reported compliance with masking was high, ranging from 92.1% to 97.4%, and in-school transmission of COVID-19 was low, with seven cases among 4,876 students.

It worked in Salt Lake City.⁴ In 20 elementary schools open for in-person instruction Dec. 3, 2020, to Jan. 31, 2021, compliance with mask-wearing was high and in-school transmission was very low, despite a high community incidence of COVID-19. Notably, students’ classroom seats were less than 6 feet apart, suggesting that consistent mask-wearing works even when physical distancing is challenging.

One of the best examples of successful school reopening happened in North Carolina, where pediatricians, pediatric infectious disease specialists, and other experts affiliated with Duke University formed the ABC Science Collaborative to support school districts that requested scientific input to help guide return-to-school policies during the COVID-19 pandemic. From Oct. 26, 2020, to Feb. 28, 2021, the ABC Science Collaborative worked with 13 school districts that were open for in-person instruction using basic mitigation strategies, including universal masking.⁵ During this time period, there were 4,969 community-acquired SARS-CoV-2 infections in the more than 100,000 students and staff present in schools. Transmission to school contacts was identified in only 209 individuals for a secondary attack rate of less than 1%.

Duke investigator Kanecia Zimmerman, MD, told Duke Today, “We know that, if our goal is to reduce transmission of COVID-19 in schools, there are two effective ways to do that: 1. vaccination, 2. masking. In the setting of schools ... the science suggests masking can be extremely effective, particularly for those who can’t get vaccinated while COVID-19 is still circulating.”

Both the AAP⁶ and the Pediatric Infectious Diseases Society⁷ have emphasized the importance of in-person instruction and endorsed universal masking in school. Mask-optional policies or “mask-if-you-are-unvaccinated” policies don’t work, as we have seen in society at large. They are likely to be especially challenging in school settings. Given an option, many, if not most kids, will take off their masks. Kids who leave them on run the risk of stigmatization or bullying.

On Aug. 4, the Centers for Disease Control and Prevention updated its guidance to recommend universal indoor masking for all students, staff, teachers, and visitors to K-12 schools, regardless of vaccination status. Now we’ll have to wait and see if school districts, elected officials, and parents will get on board with masks. ... and we’ll be left to count the number of rising COVID-19 cases that occur until they do.

Case in point: Kids in Greater Clark County, Ind., headed back to school on July 28. Masks were not required on school property, although unvaccinated students and teachers were “strongly encouraged” to wear them.⁸

Over the first 8 days of in-person instruction, schools in Greater Clark County identified 70 cases of COVID-19 in students and quarantined more than 1,100 of the district’s 10,300 students. Only the unvaccinated were required to quarantine. The district began requiring masks in all school buildings on Aug. 9.⁹

The worried mother had one last question for me. “What’s the best mask for a child to wear?” For most kids, a simple, well-fitting cloth mask is fine. The best mask is ultimately the mask a child will wear. A toolkit with practical tips for helping children successfully wear a mask is available on the ABC Science Collaborative website.
 

Dr. Bryant, president of the Pediatric Infectious Diseases Society, is a pediatrician at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. American Academy of Pediatrics. “Children and COVID-19: State-level data report.”

2. American Academy of Pediatrics. “Children and COVID-19 vaccination trends.”

3. Falk A et al. MMWR Morb Mortal Wkly Rep. 2021;70:136-40.

4. Hershow RB et al. MMWR Morb Mortal Wkly Rep 2021;70:442-8.

5. Zimmerman KO et al. Pediatrics. 2021 Jul;e2021052686. doi: 10.1542/peds.2021-052686.

6. American Academy of Pediatrics. “American Academy of Pediatrics updates recommendations for opening schools in fall 2021.”

7. Pediatric Infectious Diseases Society. “PIDS supports universal masking for students, school staff.”

8. Courtney Hayden. WHAS11. “Greater Clark County Schools return to class July 28.”

9. Dustin Vogt. WAVE3 News. “Greater Clark Country Schools to require masks amid 70 positive cases.”

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

• Receiving treatment for solid tumors or blood cancers
• Taking immunosuppressing medications after a solid organ transplant
• Within 2 years of receiving CAR-T therapy or a stem cell transplant
• Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
• With advanced or untreated 
• Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
• With certain chronic medical conditions, such as  or asplenia – living without a spleen
• Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

• Receiving treatment for solid tumors or blood cancers
• Taking immunosuppressing medications after a solid organ transplant
• Within 2 years of receiving CAR-T therapy or a stem cell transplant
• Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
• With advanced or untreated 
• Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
• With certain chronic medical conditions, such as  or asplenia – living without a spleen
• Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

• Receiving treatment for solid tumors or blood cancers
• Taking immunosuppressing medications after a solid organ transplant
• Within 2 years of receiving CAR-T therapy or a stem cell transplant
• Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
• With advanced or untreated 
• Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
• With certain chronic medical conditions, such as  or asplenia – living without a spleen
• Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

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

Before the onslaught of COVID-19, researchers at the Fred Hutchinson Cancer Research Center in Seattle had another infectious disease worry: an “unprecedented” outbreak of measles.

“In 2019, we saw the most measles cases in any year since the 1990s,” said Sara Marquis, MPH, a clinical research coordinator at the center. The worry, she says, was that various oncology treatments, such as bone marrow transplantations and assorted biologics, “may leave cancer patients severely immunosuppressed” and thus vulnerable to infectious diseases.

Measles-related illness is typically not severe but can lead to pneumonia, deafness, and death, even in immunocompetent people, Ms. Marquis added.

So in 2019, a team at Fred Hutchinson initiated a study to get a sense of immunity to measles among patients with cancer.

They now report that of a group of 900-plus patients, 25% lacked protective antibodies for measles. That’s “significantly more” than the general population, in which about 8% of people lack these antibodies, Ms. Marquis said.

The study, published online in JAMA Network Open, also found that 38% lacked protection against the less-worrisome infectious disease of mumps, which is more than the 13% found in the general population.

“The scary thing about measles is that it is one of the most contagious diseases known,” Ms. Marquis told this news organization, adding that it is about twice as contagious as the COVID-19 Delta variant.

And it’s not just in the state of Washington. “We’re seeing it more and more in the community,” as various outbreaks continue to happen, she said.

“Deficits in protective antibodies underscore patients’ increased risk during outbreaks and emphasize the need for community-based efforts to increase herd immunity to protect this population,” the study authors conclude.

In short, administration of the measles-mumps-rubella (MMR) vaccine, introduced in 1963, must continue universally, they said

“We’ve had so many incredible advances in cancer treatment in recent years. … it would be devastating to see something like measles, which is a vaccine-preventable disease, come through and negate those efforts,” said study coauthor Elizabeth Krantz, MS, a biostatistician at Fred Hutchinson.

The health care teams and family caregivers of patients with cancer should also make sure they are vaccinated, said Ms. Marquis. However, some patients may not be able to get a measles booster vaccine because it is a live vaccine or because they cannot generate enough antibodies for it to be protective, she explained.
 

Three subgroups more likely to have deficits

The new study, which is one of the first to measure measles and mumps seroprevalence among patients with cancer in the modern era of cancer treatment, also identified three subgroups that more commonly had immunity deficits:  those aged 30-59 years; those with hematologic malignant neoplasms, and those who had received a hematopoietic cell transplant.

In the study, residual clinical plasma samples were obtained from 959 consecutive patients with cancer at Seattle Cancer Care Alliance and Fred Hutchinson in August 2019. These samples were tested for measles and mumps IgG by using a commercial enzyme-linked immunosorbent assay. In all, 60% of patients had a solid tumor and 40% had a blood cancer.

As noted above, the seroprevalence of measles antibodies was 0.75 and the seroprevalence of mumps antibodies was 0.62.

A study author explained why the study included mumps, a less threatening infection.

“We assessed mumps in this study out of interest to compare response in the MMR vaccine component – particularly as we could assess a potent vaccine (measles) versus one that has a weaker immunologic response (mumps). We remain worried about outbreaks of mumps as MMR vaccination rates drop across the U.S.,” wrote Steven Pergam, MD, MPH, infectious disease specialist at Fred Hutchinson, in an email.

Vaccination vigilance is one of the study’s messages. “We all need to do our part to make sure we are up to date with our vaccinations so we can make sure we protect those who are vulnerable,” said Ms. Krantz.

The study was funded by the National Cancer Institute and Seattle Cancer Care Alliance. Multiple study authors have ties to pharmaceutical companies.

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

Before the onslaught of COVID-19, researchers at the Fred Hutchinson Cancer Research Center in Seattle had another infectious disease worry: an “unprecedented” outbreak of measles.

“In 2019, we saw the most measles cases in any year since the 1990s,” said Sara Marquis, MPH, a clinical research coordinator at the center. The worry, she says, was that various oncology treatments, such as bone marrow transplantations and assorted biologics, “may leave cancer patients severely immunosuppressed” and thus vulnerable to infectious diseases.

Measles-related illness is typically not severe but can lead to pneumonia, deafness, and death, even in immunocompetent people, Ms. Marquis added.

So in 2019, a team at Fred Hutchinson initiated a study to get a sense of immunity to measles among patients with cancer.

They now report that of a group of 900-plus patients, 25% lacked protective antibodies for measles. That’s “significantly more” than the general population, in which about 8% of people lack these antibodies, Ms. Marquis said.

The study, published online in JAMA Network Open, also found that 38% lacked protection against the less-worrisome infectious disease of mumps, which is more than the 13% found in the general population.

“The scary thing about measles is that it is one of the most contagious diseases known,” Ms. Marquis told this news organization, adding that it is about twice as contagious as the COVID-19 Delta variant.

And it’s not just in the state of Washington. “We’re seeing it more and more in the community,” as various outbreaks continue to happen, she said.

“Deficits in protective antibodies underscore patients’ increased risk during outbreaks and emphasize the need for community-based efforts to increase herd immunity to protect this population,” the study authors conclude.

In short, administration of the measles-mumps-rubella (MMR) vaccine, introduced in 1963, must continue universally, they said

“We’ve had so many incredible advances in cancer treatment in recent years. … it would be devastating to see something like measles, which is a vaccine-preventable disease, come through and negate those efforts,” said study coauthor Elizabeth Krantz, MS, a biostatistician at Fred Hutchinson.

The health care teams and family caregivers of patients with cancer should also make sure they are vaccinated, said Ms. Marquis. However, some patients may not be able to get a measles booster vaccine because it is a live vaccine or because they cannot generate enough antibodies for it to be protective, she explained.
 

Three subgroups more likely to have deficits

The new study, which is one of the first to measure measles and mumps seroprevalence among patients with cancer in the modern era of cancer treatment, also identified three subgroups that more commonly had immunity deficits:  those aged 30-59 years; those with hematologic malignant neoplasms, and those who had received a hematopoietic cell transplant.

In the study, residual clinical plasma samples were obtained from 959 consecutive patients with cancer at Seattle Cancer Care Alliance and Fred Hutchinson in August 2019. These samples were tested for measles and mumps IgG by using a commercial enzyme-linked immunosorbent assay. In all, 60% of patients had a solid tumor and 40% had a blood cancer.

As noted above, the seroprevalence of measles antibodies was 0.75 and the seroprevalence of mumps antibodies was 0.62.

A study author explained why the study included mumps, a less threatening infection.

“We assessed mumps in this study out of interest to compare response in the MMR vaccine component – particularly as we could assess a potent vaccine (measles) versus one that has a weaker immunologic response (mumps). We remain worried about outbreaks of mumps as MMR vaccination rates drop across the U.S.,” wrote Steven Pergam, MD, MPH, infectious disease specialist at Fred Hutchinson, in an email.

Vaccination vigilance is one of the study’s messages. “We all need to do our part to make sure we are up to date with our vaccinations so we can make sure we protect those who are vulnerable,” said Ms. Krantz.

The study was funded by the National Cancer Institute and Seattle Cancer Care Alliance. Multiple study authors have ties to pharmaceutical companies.

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

Before the onslaught of COVID-19, researchers at the Fred Hutchinson Cancer Research Center in Seattle had another infectious disease worry: an “unprecedented” outbreak of measles.

“In 2019, we saw the most measles cases in any year since the 1990s,” said Sara Marquis, MPH, a clinical research coordinator at the center. The worry, she says, was that various oncology treatments, such as bone marrow transplantations and assorted biologics, “may leave cancer patients severely immunosuppressed” and thus vulnerable to infectious diseases.

Measles-related illness is typically not severe but can lead to pneumonia, deafness, and death, even in immunocompetent people, Ms. Marquis added.

So in 2019, a team at Fred Hutchinson initiated a study to get a sense of immunity to measles among patients with cancer.

They now report that of a group of 900-plus patients, 25% lacked protective antibodies for measles. That’s “significantly more” than the general population, in which about 8% of people lack these antibodies, Ms. Marquis said.

The study, published online in JAMA Network Open, also found that 38% lacked protection against the less-worrisome infectious disease of mumps, which is more than the 13% found in the general population.

“The scary thing about measles is that it is one of the most contagious diseases known,” Ms. Marquis told this news organization, adding that it is about twice as contagious as the COVID-19 Delta variant.

And it’s not just in the state of Washington. “We’re seeing it more and more in the community,” as various outbreaks continue to happen, she said.

“Deficits in protective antibodies underscore patients’ increased risk during outbreaks and emphasize the need for community-based efforts to increase herd immunity to protect this population,” the study authors conclude.

In short, administration of the measles-mumps-rubella (MMR) vaccine, introduced in 1963, must continue universally, they said

“We’ve had so many incredible advances in cancer treatment in recent years. … it would be devastating to see something like measles, which is a vaccine-preventable disease, come through and negate those efforts,” said study coauthor Elizabeth Krantz, MS, a biostatistician at Fred Hutchinson.

The health care teams and family caregivers of patients with cancer should also make sure they are vaccinated, said Ms. Marquis. However, some patients may not be able to get a measles booster vaccine because it is a live vaccine or because they cannot generate enough antibodies for it to be protective, she explained.
 

Three subgroups more likely to have deficits

The new study, which is one of the first to measure measles and mumps seroprevalence among patients with cancer in the modern era of cancer treatment, also identified three subgroups that more commonly had immunity deficits:  those aged 30-59 years; those with hematologic malignant neoplasms, and those who had received a hematopoietic cell transplant.

In the study, residual clinical plasma samples were obtained from 959 consecutive patients with cancer at Seattle Cancer Care Alliance and Fred Hutchinson in August 2019. These samples were tested for measles and mumps IgG by using a commercial enzyme-linked immunosorbent assay. In all, 60% of patients had a solid tumor and 40% had a blood cancer.

As noted above, the seroprevalence of measles antibodies was 0.75 and the seroprevalence of mumps antibodies was 0.62.

A study author explained why the study included mumps, a less threatening infection.

“We assessed mumps in this study out of interest to compare response in the MMR vaccine component – particularly as we could assess a potent vaccine (measles) versus one that has a weaker immunologic response (mumps). We remain worried about outbreaks of mumps as MMR vaccination rates drop across the U.S.,” wrote Steven Pergam, MD, MPH, infectious disease specialist at Fred Hutchinson, in an email.

Vaccination vigilance is one of the study’s messages. “We all need to do our part to make sure we are up to date with our vaccinations so we can make sure we protect those who are vulnerable,” said Ms. Krantz.

The study was funded by the National Cancer Institute and Seattle Cancer Care Alliance. Multiple study authors have ties to pharmaceutical companies.

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

The Centers for Disease Control and Prevention and Food and Drug Administration have announced an outbreak of at least 15 Burkholderia cepacia infections associated with contaminated ultrasound gel used to guide invasive procedures as well as an unrelated outbreak of Burkholderia pseudomallei that caused two deaths.

The procedures involved in the B. cepacia outbreak included placement of both central and peripheral intravenous catheters and paracentesis (removal of peritoneal fluid from the abdominal cavity). Cases have occurred in several states.

Further testing has shown the presence of Burkholderia stabilis, a member of B. cepacia complex (Bcc), in four lots of unopened bottles of MediChoice M500812 ultrasound gel. Eco-Med Pharmaceuticals of Etobicoke, Ont., the parent manufacturer, has issued a recall of MediChoice M500812 or Eco-Gel 200 with the following lot numbers: B029, B030, B031, B032, B040, B041, B048, B055. A similar outbreak occurred in Canada.

Some of these cases resulted in bloodstream infections. Further details are not yet available. Bcc infections have ranged from asymptomatic to life-threatening pneumonias, particularly in patients with cystic fibrosis. Other risk factors include immunosuppression, mechanical ventilation, and the use of other invasive venous or urinary catheters.

Kiran M. Perkins, MD, MPH, outbreak lead with the CDC’s Prevention Research Branch, said in an interview via email that automated systems such as Vitek might have trouble identifying the organism as “the system may only reveal the microbial species at the genus level but not at the species level, and/or it may have difficulty distinguishing between members of closely related group members.”

In the CDC’s experience, “most facilities do not conduct further species identification.” The agency added that it cannot tell if there has been any increase in cases associated with COVID-19, as they are not notifiable diseases and the “CDC does not systematically collect information on B. cepacia complex infections.”

Rodney Rohde, PhD, professor of clinical laboratory science and chair of the clinical laboratory science program, Texas State University, San Marcos, told this news organization via email that Burkholderia’s “detection in the manufacturing process is difficult, and product recalls are frequent.” He added, “A recent review by the Food and Drug Administration in the U.S. found that almost 40% of contamination reports in both sterile and nonsterile pharmaceutical products were caused by Bcc bacteria.” Another problem is that they often create biofilms, so “they are tenacious environmental colonizers of medical equipment and surfaces in general.”

There have been many other outbreaks as a result to B. cepacia complex. Because it is often in the water supply used in pharmaceutical manufacturing and is resistant to preservatives, the FDA cautions that it poses a risk of contamination in all nonsterile, water-based drug products.

Recalls have included contaminated antiseptics, such as povidone iodine, benzalkonium chloride, and chlorhexidine gluconate. Contamination in manufacturing may not be uniform, and only some samples may be affected. Antiseptic mouthwashes have also been affected. So have nonbacterial soaps and docusate (a stool softener) solutions, and various personal care products, including nasal sprays, lotions, simethicone gas relief drops (Mylicon), and baby wipes.

Although Bcc are considered “objectionable organisms,” there have been no strong or consistent standards for their detection from the U.S. Pharmacopeia, and some manufacturers reportedly underestimate the consequences of contamination. The FDA issued a guidance to manufacturers in 2017 on quality assurance and cleaning procedures. This is particularly important since preservatives are ineffective against Bcc, and sterility has to be insured at each step of production.

Burkholderia isolates are generally resistant to commonly used antibiotics. Treatment might therefore include a combination of two drugs (to try to limit the emergence of more resistance) such as ceftazidime, piperacillin, meropenem with trimethoprim-sulfamethoxazole, or a beta-lactam plus aminoglycoside.

Interestingly, an outbreak of Burkholderia pseudomallei was just reported by the CDC as well. This is a related gram-negative bacillus which is quite uncommon in the United States. It causes melioidosis, usually a tropical infection, which presents with nonspecific symptoms or serious pneumonia, abscesses, or bloodstream infections.

Four cases have been identified this year in Georgia, Kansas, Minnesota, and Texas, two of them fatal. It is usually acquired from soil or water. By genomic analysis, the four cases are felt to be related, but no common source of exposure has been identified. They also appear to be closely related to South Asian strains, although none of the patients had traveled internationally. Prolonged antibiotic therapy with ceftazidime or meropenem, followed by 3-6 months of trimethoprim-sulfamethoxazole, is often required.

In his email, Dr. Rohde stated, “Melioidosis causes cough, chest pain, high fever, headache or unexplained weight loss, but it may take 2-3 weeks for symptoms of melioidosis to appear after a person’s initial exposure to the bacteria. So, one could see how this might be overlooked as COVID per symptoms and per the limitations of laboratory identification.”

It’s essential for clinicians to recognize that automated microbiology identification systems can misidentify B. pseudomallei as B. cepacia and to ask the lab for more specialized molecular diagnostics, particularly when relatively unusual organisms are isolated.

Candice Hoffmann, a public affairs specialist at the CDC, told this news organization that “clinicians should consider melioidosis as a differential diagnosis in both adult and pediatric patients who are suspected to have a bacterial infection (pneumonia, sepsis, meningitis, wound) and are not responding to antibacterial treatment, even if they have not traveled outside of the continental United States.”

Dr. Rohde has disclosed no relevant financial relationships.

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

The Centers for Disease Control and Prevention and Food and Drug Administration have announced an outbreak of at least 15 Burkholderia cepacia infections associated with contaminated ultrasound gel used to guide invasive procedures as well as an unrelated outbreak of Burkholderia pseudomallei that caused two deaths.

The procedures involved in the B. cepacia outbreak included placement of both central and peripheral intravenous catheters and paracentesis (removal of peritoneal fluid from the abdominal cavity). Cases have occurred in several states.

Further testing has shown the presence of Burkholderia stabilis, a member of B. cepacia complex (Bcc), in four lots of unopened bottles of MediChoice M500812 ultrasound gel. Eco-Med Pharmaceuticals of Etobicoke, Ont., the parent manufacturer, has issued a recall of MediChoice M500812 or Eco-Gel 200 with the following lot numbers: B029, B030, B031, B032, B040, B041, B048, B055. A similar outbreak occurred in Canada.

Some of these cases resulted in bloodstream infections. Further details are not yet available. Bcc infections have ranged from asymptomatic to life-threatening pneumonias, particularly in patients with cystic fibrosis. Other risk factors include immunosuppression, mechanical ventilation, and the use of other invasive venous or urinary catheters.

Kiran M. Perkins, MD, MPH, outbreak lead with the CDC’s Prevention Research Branch, said in an interview via email that automated systems such as Vitek might have trouble identifying the organism as “the system may only reveal the microbial species at the genus level but not at the species level, and/or it may have difficulty distinguishing between members of closely related group members.”

In the CDC’s experience, “most facilities do not conduct further species identification.” The agency added that it cannot tell if there has been any increase in cases associated with COVID-19, as they are not notifiable diseases and the “CDC does not systematically collect information on B. cepacia complex infections.”

Rodney Rohde, PhD, professor of clinical laboratory science and chair of the clinical laboratory science program, Texas State University, San Marcos, told this news organization via email that Burkholderia’s “detection in the manufacturing process is difficult, and product recalls are frequent.” He added, “A recent review by the Food and Drug Administration in the U.S. found that almost 40% of contamination reports in both sterile and nonsterile pharmaceutical products were caused by Bcc bacteria.” Another problem is that they often create biofilms, so “they are tenacious environmental colonizers of medical equipment and surfaces in general.”

There have been many other outbreaks as a result to B. cepacia complex. Because it is often in the water supply used in pharmaceutical manufacturing and is resistant to preservatives, the FDA cautions that it poses a risk of contamination in all nonsterile, water-based drug products.

Recalls have included contaminated antiseptics, such as povidone iodine, benzalkonium chloride, and chlorhexidine gluconate. Contamination in manufacturing may not be uniform, and only some samples may be affected. Antiseptic mouthwashes have also been affected. So have nonbacterial soaps and docusate (a stool softener) solutions, and various personal care products, including nasal sprays, lotions, simethicone gas relief drops (Mylicon), and baby wipes.

Although Bcc are considered “objectionable organisms,” there have been no strong or consistent standards for their detection from the U.S. Pharmacopeia, and some manufacturers reportedly underestimate the consequences of contamination. The FDA issued a guidance to manufacturers in 2017 on quality assurance and cleaning procedures. This is particularly important since preservatives are ineffective against Bcc, and sterility has to be insured at each step of production.

Burkholderia isolates are generally resistant to commonly used antibiotics. Treatment might therefore include a combination of two drugs (to try to limit the emergence of more resistance) such as ceftazidime, piperacillin, meropenem with trimethoprim-sulfamethoxazole, or a beta-lactam plus aminoglycoside.

Interestingly, an outbreak of Burkholderia pseudomallei was just reported by the CDC as well. This is a related gram-negative bacillus which is quite uncommon in the United States. It causes melioidosis, usually a tropical infection, which presents with nonspecific symptoms or serious pneumonia, abscesses, or bloodstream infections.

Four cases have been identified this year in Georgia, Kansas, Minnesota, and Texas, two of them fatal. It is usually acquired from soil or water. By genomic analysis, the four cases are felt to be related, but no common source of exposure has been identified. They also appear to be closely related to South Asian strains, although none of the patients had traveled internationally. Prolonged antibiotic therapy with ceftazidime or meropenem, followed by 3-6 months of trimethoprim-sulfamethoxazole, is often required.

In his email, Dr. Rohde stated, “Melioidosis causes cough, chest pain, high fever, headache or unexplained weight loss, but it may take 2-3 weeks for symptoms of melioidosis to appear after a person’s initial exposure to the bacteria. So, one could see how this might be overlooked as COVID per symptoms and per the limitations of laboratory identification.”

It’s essential for clinicians to recognize that automated microbiology identification systems can misidentify B. pseudomallei as B. cepacia and to ask the lab for more specialized molecular diagnostics, particularly when relatively unusual organisms are isolated.

Candice Hoffmann, a public affairs specialist at the CDC, told this news organization that “clinicians should consider melioidosis as a differential diagnosis in both adult and pediatric patients who are suspected to have a bacterial infection (pneumonia, sepsis, meningitis, wound) and are not responding to antibacterial treatment, even if they have not traveled outside of the continental United States.”

Dr. Rohde has disclosed no relevant financial relationships.

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

The Centers for Disease Control and Prevention and Food and Drug Administration have announced an outbreak of at least 15 Burkholderia cepacia infections associated with contaminated ultrasound gel used to guide invasive procedures as well as an unrelated outbreak of Burkholderia pseudomallei that caused two deaths.

The procedures involved in the B. cepacia outbreak included placement of both central and peripheral intravenous catheters and paracentesis (removal of peritoneal fluid from the abdominal cavity). Cases have occurred in several states.

Further testing has shown the presence of Burkholderia stabilis, a member of B. cepacia complex (Bcc), in four lots of unopened bottles of MediChoice M500812 ultrasound gel. Eco-Med Pharmaceuticals of Etobicoke, Ont., the parent manufacturer, has issued a recall of MediChoice M500812 or Eco-Gel 200 with the following lot numbers: B029, B030, B031, B032, B040, B041, B048, B055. A similar outbreak occurred in Canada.

Some of these cases resulted in bloodstream infections. Further details are not yet available. Bcc infections have ranged from asymptomatic to life-threatening pneumonias, particularly in patients with cystic fibrosis. Other risk factors include immunosuppression, mechanical ventilation, and the use of other invasive venous or urinary catheters.

Kiran M. Perkins, MD, MPH, outbreak lead with the CDC’s Prevention Research Branch, said in an interview via email that automated systems such as Vitek might have trouble identifying the organism as “the system may only reveal the microbial species at the genus level but not at the species level, and/or it may have difficulty distinguishing between members of closely related group members.”

In the CDC’s experience, “most facilities do not conduct further species identification.” The agency added that it cannot tell if there has been any increase in cases associated with COVID-19, as they are not notifiable diseases and the “CDC does not systematically collect information on B. cepacia complex infections.”

Rodney Rohde, PhD, professor of clinical laboratory science and chair of the clinical laboratory science program, Texas State University, San Marcos, told this news organization via email that Burkholderia’s “detection in the manufacturing process is difficult, and product recalls are frequent.” He added, “A recent review by the Food and Drug Administration in the U.S. found that almost 40% of contamination reports in both sterile and nonsterile pharmaceutical products were caused by Bcc bacteria.” Another problem is that they often create biofilms, so “they are tenacious environmental colonizers of medical equipment and surfaces in general.”

There have been many other outbreaks as a result to B. cepacia complex. Because it is often in the water supply used in pharmaceutical manufacturing and is resistant to preservatives, the FDA cautions that it poses a risk of contamination in all nonsterile, water-based drug products.

Recalls have included contaminated antiseptics, such as povidone iodine, benzalkonium chloride, and chlorhexidine gluconate. Contamination in manufacturing may not be uniform, and only some samples may be affected. Antiseptic mouthwashes have also been affected. So have nonbacterial soaps and docusate (a stool softener) solutions, and various personal care products, including nasal sprays, lotions, simethicone gas relief drops (Mylicon), and baby wipes.

Although Bcc are considered “objectionable organisms,” there have been no strong or consistent standards for their detection from the U.S. Pharmacopeia, and some manufacturers reportedly underestimate the consequences of contamination. The FDA issued a guidance to manufacturers in 2017 on quality assurance and cleaning procedures. This is particularly important since preservatives are ineffective against Bcc, and sterility has to be insured at each step of production.

Burkholderia isolates are generally resistant to commonly used antibiotics. Treatment might therefore include a combination of two drugs (to try to limit the emergence of more resistance) such as ceftazidime, piperacillin, meropenem with trimethoprim-sulfamethoxazole, or a beta-lactam plus aminoglycoside.

Interestingly, an outbreak of Burkholderia pseudomallei was just reported by the CDC as well. This is a related gram-negative bacillus which is quite uncommon in the United States. It causes melioidosis, usually a tropical infection, which presents with nonspecific symptoms or serious pneumonia, abscesses, or bloodstream infections.

Four cases have been identified this year in Georgia, Kansas, Minnesota, and Texas, two of them fatal. It is usually acquired from soil or water. By genomic analysis, the four cases are felt to be related, but no common source of exposure has been identified. They also appear to be closely related to South Asian strains, although none of the patients had traveled internationally. Prolonged antibiotic therapy with ceftazidime or meropenem, followed by 3-6 months of trimethoprim-sulfamethoxazole, is often required.

In his email, Dr. Rohde stated, “Melioidosis causes cough, chest pain, high fever, headache or unexplained weight loss, but it may take 2-3 weeks for symptoms of melioidosis to appear after a person’s initial exposure to the bacteria. So, one could see how this might be overlooked as COVID per symptoms and per the limitations of laboratory identification.”

It’s essential for clinicians to recognize that automated microbiology identification systems can misidentify B. pseudomallei as B. cepacia and to ask the lab for more specialized molecular diagnostics, particularly when relatively unusual organisms are isolated.

Candice Hoffmann, a public affairs specialist at the CDC, told this news organization that “clinicians should consider melioidosis as a differential diagnosis in both adult and pediatric patients who are suspected to have a bacterial infection (pneumonia, sepsis, meningitis, wound) and are not responding to antibacterial treatment, even if they have not traveled outside of the continental United States.”

Dr. Rohde has disclosed no relevant financial relationships.

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

The American Society for Clinical Pathology (ASCP), which represents over 100,000 pathologists and medical laboratory professionals, has called for a nationwide vaccination mandate. It is the first medical specialty society to do so, ASCP chief executive officer Blair Holladay, PhD, said in an interview.

However, the American Lung Association this week said it supports President Biden’s call for businesses to require their employees to be vaccinated. In addition, more than 50 medical societies, including ASCP, recently said they support vaccination mandates for health care workers.

In a position statement released Wednesday, ASCP recommended that every eligible American be vaccinated. “The U.S. Food and Drug Administration is soon expected to fully approve at least one COVID-19 vaccine, and when it does, we urge that vaccination requirements become the norm,” the society said.

Second, ASCP noted that at least 16 states have enacted some form of a ban on COVID-19 vaccine mandates or related requirements. These include blocking employment-based mandates, school vaccination or mask requirements, and vaccine passport requirements.

“These laws prolong the pandemic and threaten the health and safety of every American. They should be repealed or overturned immediately,” the association stated.

Third, ASCP said, it supports the guidance of the Centers for Disease Control and Prevention that masks should be worn indoors in public places in areas of substantial or high COVID-19 transmission.

“Before more people die, our elected leaders need to take serious and aggressive action to ensure that Americans get vaccinated, so we can end the pandemic, end patient and family suffering, end the fatalities, and get back to the lives we had before COVID-19,” the statement concluded.
 

Laboratories have to focus on COVID again

In his interview, Dr. Holladay noted that the eruption of the Delta variant across the country has again forced laboratories to focus on COVID-19 testing at the expense of necessary tests related to other diseases.

“Because 7 of 10 medical decisions depend on the laboratory, anything that interferes with that interferes with the needs of patient care, including preventive, chronic, and acute care services,” he said.

This is a major reason, he said, for ASCP to support a national vaccination mandate. “People have postponed treatment because of the inability to access medical care [for other conditions],” he noted. The same is true for preventive or diagnostic care such as biopsies for breast cancer and colonoscopies, he added.

“In many parts of the country, the throughput of COVID tests made it difficult for us to focus on tests for other acute conditions. It overwhelmed the laboratory personnel in terms of the number of tests being run.”
 

Returning to the ‘dark days’

This was a significant issue in the earlier part of the pandemic, Dr. Holladay recalled. The shortage of non-COVID lab capacity eased in the spring and early summer of 2021, when COVID-19 vaccines became widely available.

“But with the Delta variant, we’re going back to those dark days and creating the same bottleneck that we saw in the beginning,” he said.

Although the situation is worse in some states than others, Dr. Holladay added, some of the hardest-hit states like Florida and Texas have very large populations.

“This is not just about doctors, nurses, pathologists, and laboratory personnel being exhausted,” commented Kimberly Sanford, MD, president of ASCP, in a press release. “Laboratory medicine is absolutely necessary for accurate and timely diagnosis of disease, infection control, and effective treatment planning. It is an essential part of the health care system and often overwhelmed by the increasing number of coronavirus tests requiring immediate analysis.

“Such testing takes time and disproportionately consumes scarce equipment and other resources. It means those with cancer and other life-threatening conditions face serious delays in diagnosis and treatment. It delays medical diagnoses, erects barriers to preventative care, and prevents us from focusing on the significant health care needs of the population at large.”

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

The American Society for Clinical Pathology (ASCP), which represents over 100,000 pathologists and medical laboratory professionals, has called for a nationwide vaccination mandate. It is the first medical specialty society to do so, ASCP chief executive officer Blair Holladay, PhD, said in an interview.

However, the American Lung Association this week said it supports President Biden’s call for businesses to require their employees to be vaccinated. In addition, more than 50 medical societies, including ASCP, recently said they support vaccination mandates for health care workers.

In a position statement released Wednesday, ASCP recommended that every eligible American be vaccinated. “The U.S. Food and Drug Administration is soon expected to fully approve at least one COVID-19 vaccine, and when it does, we urge that vaccination requirements become the norm,” the society said.

Second, ASCP noted that at least 16 states have enacted some form of a ban on COVID-19 vaccine mandates or related requirements. These include blocking employment-based mandates, school vaccination or mask requirements, and vaccine passport requirements.

“These laws prolong the pandemic and threaten the health and safety of every American. They should be repealed or overturned immediately,” the association stated.

Third, ASCP said, it supports the guidance of the Centers for Disease Control and Prevention that masks should be worn indoors in public places in areas of substantial or high COVID-19 transmission.

“Before more people die, our elected leaders need to take serious and aggressive action to ensure that Americans get vaccinated, so we can end the pandemic, end patient and family suffering, end the fatalities, and get back to the lives we had before COVID-19,” the statement concluded.
 

Laboratories have to focus on COVID again

In his interview, Dr. Holladay noted that the eruption of the Delta variant across the country has again forced laboratories to focus on COVID-19 testing at the expense of necessary tests related to other diseases.

“Because 7 of 10 medical decisions depend on the laboratory, anything that interferes with that interferes with the needs of patient care, including preventive, chronic, and acute care services,” he said.

This is a major reason, he said, for ASCP to support a national vaccination mandate. “People have postponed treatment because of the inability to access medical care [for other conditions],” he noted. The same is true for preventive or diagnostic care such as biopsies for breast cancer and colonoscopies, he added.

“In many parts of the country, the throughput of COVID tests made it difficult for us to focus on tests for other acute conditions. It overwhelmed the laboratory personnel in terms of the number of tests being run.”
 

Returning to the ‘dark days’

This was a significant issue in the earlier part of the pandemic, Dr. Holladay recalled. The shortage of non-COVID lab capacity eased in the spring and early summer of 2021, when COVID-19 vaccines became widely available.

“But with the Delta variant, we’re going back to those dark days and creating the same bottleneck that we saw in the beginning,” he said.

Although the situation is worse in some states than others, Dr. Holladay added, some of the hardest-hit states like Florida and Texas have very large populations.

“This is not just about doctors, nurses, pathologists, and laboratory personnel being exhausted,” commented Kimberly Sanford, MD, president of ASCP, in a press release. “Laboratory medicine is absolutely necessary for accurate and timely diagnosis of disease, infection control, and effective treatment planning. It is an essential part of the health care system and often overwhelmed by the increasing number of coronavirus tests requiring immediate analysis.

“Such testing takes time and disproportionately consumes scarce equipment and other resources. It means those with cancer and other life-threatening conditions face serious delays in diagnosis and treatment. It delays medical diagnoses, erects barriers to preventative care, and prevents us from focusing on the significant health care needs of the population at large.”

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

The American Society for Clinical Pathology (ASCP), which represents over 100,000 pathologists and medical laboratory professionals, has called for a nationwide vaccination mandate. It is the first medical specialty society to do so, ASCP chief executive officer Blair Holladay, PhD, said in an interview.

However, the American Lung Association this week said it supports President Biden’s call for businesses to require their employees to be vaccinated. In addition, more than 50 medical societies, including ASCP, recently said they support vaccination mandates for health care workers.

In a position statement released Wednesday, ASCP recommended that every eligible American be vaccinated. “The U.S. Food and Drug Administration is soon expected to fully approve at least one COVID-19 vaccine, and when it does, we urge that vaccination requirements become the norm,” the society said.

Second, ASCP noted that at least 16 states have enacted some form of a ban on COVID-19 vaccine mandates or related requirements. These include blocking employment-based mandates, school vaccination or mask requirements, and vaccine passport requirements.

“These laws prolong the pandemic and threaten the health and safety of every American. They should be repealed or overturned immediately,” the association stated.

Third, ASCP said, it supports the guidance of the Centers for Disease Control and Prevention that masks should be worn indoors in public places in areas of substantial or high COVID-19 transmission.

“Before more people die, our elected leaders need to take serious and aggressive action to ensure that Americans get vaccinated, so we can end the pandemic, end patient and family suffering, end the fatalities, and get back to the lives we had before COVID-19,” the statement concluded.
 

Laboratories have to focus on COVID again

In his interview, Dr. Holladay noted that the eruption of the Delta variant across the country has again forced laboratories to focus on COVID-19 testing at the expense of necessary tests related to other diseases.

“Because 7 of 10 medical decisions depend on the laboratory, anything that interferes with that interferes with the needs of patient care, including preventive, chronic, and acute care services,” he said.

This is a major reason, he said, for ASCP to support a national vaccination mandate. “People have postponed treatment because of the inability to access medical care [for other conditions],” he noted. The same is true for preventive or diagnostic care such as biopsies for breast cancer and colonoscopies, he added.

“In many parts of the country, the throughput of COVID tests made it difficult for us to focus on tests for other acute conditions. It overwhelmed the laboratory personnel in terms of the number of tests being run.”
 

Returning to the ‘dark days’

This was a significant issue in the earlier part of the pandemic, Dr. Holladay recalled. The shortage of non-COVID lab capacity eased in the spring and early summer of 2021, when COVID-19 vaccines became widely available.

“But with the Delta variant, we’re going back to those dark days and creating the same bottleneck that we saw in the beginning,” he said.

Although the situation is worse in some states than others, Dr. Holladay added, some of the hardest-hit states like Florida and Texas have very large populations.

“This is not just about doctors, nurses, pathologists, and laboratory personnel being exhausted,” commented Kimberly Sanford, MD, president of ASCP, in a press release. “Laboratory medicine is absolutely necessary for accurate and timely diagnosis of disease, infection control, and effective treatment planning. It is an essential part of the health care system and often overwhelmed by the increasing number of coronavirus tests requiring immediate analysis.

“Such testing takes time and disproportionately consumes scarce equipment and other resources. It means those with cancer and other life-threatening conditions face serious delays in diagnosis and treatment. It delays medical diagnoses, erects barriers to preventative care, and prevents us from focusing on the significant health care needs of the population at large.”

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

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

Tachycardia is commonly reported in patients with post-acute COVID-19 syndrome (PACS), also known as long COVID, authors report in a new article. The researchers say tachycardia syndrome should be considered a distinct phenotype.

The study by Marcus Ståhlberg, MD, PhD, of Karolinska University Hospital, Stockholm, and colleagues was published online August 11 in The American Journal of Medicine.

Dr. Ståhlberg told this news organization that although much attention has been paid to cases of clotting and perimyocarditis in patients after COVID, relatively little attention has been paid to tachycardia, despite case reports that show that palpitations are a common complaint.

“We have diagnosed a large number of patients with postural orthostatic tachycardia syndrome [POTS] and other forms of COVID-related tachycardia at our post-COVID outpatient clinic at Karolinska University Hospital and wanted to highlight this phenomenon,” he said.

Between 25% and 50% of patients at the clinic report tachycardia and/or palpitations that last 12 weeks or longer, the authors report.

“Systematic investigations suggest that 9% of Post-acute COVID-19 syndrome patients report palpitations at six months,” the authors write.

The findings also shed light on potential tests and treatments, he said.

“Physicians should be liberal in performing a basic cardiological workup, including an ECG [electrocardiogram], echocardiography, and Holter ECG monitoring in patients complaining of palpitations and/or chest pain,” Dr. Ståhlberg said.

“If orthostatic intolerance is also reported – such as vertigo, nausea, dyspnea – suspicion of POTS should be raised and a head-up tilt test or at least an active standing test should be performed,” he said.

If POTS is confirmed, he said, patients should be offered a heart rate–lowering drug, such as low-dose propranolol or ivabradine. Compression garments, increased fluid intake, and a structured rehabilitation program also help.

“According to our clinical experience, ivabradine can also reduce symptoms in patients with inappropriate sinus tachycardia and post-COVID,” Dr. Ståhlberg said. “Another finding on Holter-ECG to look out for is frequent premature extrasystoles, which could indicate myocarditis and should warrant a cardiac MRI.”

Dr. Ståhlberg said the researchers think the mechanism underlying the tachycardia is autoimmune and that primary SARS-CoV-2 infections trigger an autoimmune response with formation of autoantibodies that can activate receptors regulating blood pressure and heart rate.

Long-lasting symptoms from COVID are prevalent, the authors note, especially in patients who experienced severe forms of the disease.

In the longest follow-up study to date of patients hospitalized with COVID, more than 60% experienced fatigue or muscle weakness 6 months after hospitalization.

PACS should not be considered a single syndrome; the term denotes an array of subsyndromes and phenotypes, the authors write. Typical symptoms include headache, fatigue, dyspnea, and mental fog but can involve multiple organs and systems.

Tachycardia can also be used as a marker to help gauge the severity of long COVID, the authors write.

“[T]achycardia can be considered a universal and easily obtainable quantitative marker of Post-acute COVID-19 syndrome and its severity rather than patient-reported symptoms, blood testing, and thoracic CT-scans,” they write.

An underrecognized complication

Erin D. Michos, MD, MHS, director of women’s cardiovascular health and associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview that she has seen many similar symptoms in the long-COVID patients referred to her practice.

Dr. Michos, who is also an associate professor of medicine and epidemiology, said she’s been receiving a “huge number” of referrals of long-COVID patients with postural tachycardia, inappropriate sinus tachycardia, and POTS.

“I think this is all in the spectrum of autonomic dysfunction that has been recognized a lot since COVID. POTS has been thought to have [a potentially] viral cause that triggers an autoimmune response. Even before COVID, many patients had POTS triggered by a viral infection. The question is whether COVID-related POTS for long COVID is different from other kinds of POTS.”

She says she treats long-COVID patients who complain of elevated heart rates with many of the cardiac workup procedures the authors list and that she treats them in a way similar to the way she treats patients with POTS.

She recommends checking resting oxygen levels and having patients walk the halls and measure their oxygen levels after walking, because their elevated heart rate may be related to ongoing lung injury from COVID.

Eric Adler, MD, a cardiologist with University of San Diego Health, told this news organization that the findings by Dr. Ståhlberg and colleagues are consistent with what he’s seeing in his clinical practice.

Dr. Adler agrees with the authors that tachycardia is an underrecognized complication of long COVID.

He said the article represents further proof that though people may survive COVID, the threat of long-term symptoms, such as heart palpitations, is real and supports the case for vaccinations.

The authors, Dr. Michos, and Dr. Adler have disclosed no relevant financial relationships.

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

Tachycardia is commonly reported in patients with post-acute COVID-19 syndrome (PACS), also known as long COVID, authors report in a new article. The researchers say tachycardia syndrome should be considered a distinct phenotype.

The study by Marcus Ståhlberg, MD, PhD, of Karolinska University Hospital, Stockholm, and colleagues was published online August 11 in The American Journal of Medicine.

Dr. Ståhlberg told this news organization that although much attention has been paid to cases of clotting and perimyocarditis in patients after COVID, relatively little attention has been paid to tachycardia, despite case reports that show that palpitations are a common complaint.

“We have diagnosed a large number of patients with postural orthostatic tachycardia syndrome [POTS] and other forms of COVID-related tachycardia at our post-COVID outpatient clinic at Karolinska University Hospital and wanted to highlight this phenomenon,” he said.

Between 25% and 50% of patients at the clinic report tachycardia and/or palpitations that last 12 weeks or longer, the authors report.

“Systematic investigations suggest that 9% of Post-acute COVID-19 syndrome patients report palpitations at six months,” the authors write.

The findings also shed light on potential tests and treatments, he said.

“Physicians should be liberal in performing a basic cardiological workup, including an ECG [electrocardiogram], echocardiography, and Holter ECG monitoring in patients complaining of palpitations and/or chest pain,” Dr. Ståhlberg said.

“If orthostatic intolerance is also reported – such as vertigo, nausea, dyspnea – suspicion of POTS should be raised and a head-up tilt test or at least an active standing test should be performed,” he said.

If POTS is confirmed, he said, patients should be offered a heart rate–lowering drug, such as low-dose propranolol or ivabradine. Compression garments, increased fluid intake, and a structured rehabilitation program also help.

“According to our clinical experience, ivabradine can also reduce symptoms in patients with inappropriate sinus tachycardia and post-COVID,” Dr. Ståhlberg said. “Another finding on Holter-ECG to look out for is frequent premature extrasystoles, which could indicate myocarditis and should warrant a cardiac MRI.”

Dr. Ståhlberg said the researchers think the mechanism underlying the tachycardia is autoimmune and that primary SARS-CoV-2 infections trigger an autoimmune response with formation of autoantibodies that can activate receptors regulating blood pressure and heart rate.

Long-lasting symptoms from COVID are prevalent, the authors note, especially in patients who experienced severe forms of the disease.

In the longest follow-up study to date of patients hospitalized with COVID, more than 60% experienced fatigue or muscle weakness 6 months after hospitalization.

PACS should not be considered a single syndrome; the term denotes an array of subsyndromes and phenotypes, the authors write. Typical symptoms include headache, fatigue, dyspnea, and mental fog but can involve multiple organs and systems.

Tachycardia can also be used as a marker to help gauge the severity of long COVID, the authors write.

“[T]achycardia can be considered a universal and easily obtainable quantitative marker of Post-acute COVID-19 syndrome and its severity rather than patient-reported symptoms, blood testing, and thoracic CT-scans,” they write.

An underrecognized complication

Erin D. Michos, MD, MHS, director of women’s cardiovascular health and associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview that she has seen many similar symptoms in the long-COVID patients referred to her practice.

Dr. Michos, who is also an associate professor of medicine and epidemiology, said she’s been receiving a “huge number” of referrals of long-COVID patients with postural tachycardia, inappropriate sinus tachycardia, and POTS.

“I think this is all in the spectrum of autonomic dysfunction that has been recognized a lot since COVID. POTS has been thought to have [a potentially] viral cause that triggers an autoimmune response. Even before COVID, many patients had POTS triggered by a viral infection. The question is whether COVID-related POTS for long COVID is different from other kinds of POTS.”

She says she treats long-COVID patients who complain of elevated heart rates with many of the cardiac workup procedures the authors list and that she treats them in a way similar to the way she treats patients with POTS.

She recommends checking resting oxygen levels and having patients walk the halls and measure their oxygen levels after walking, because their elevated heart rate may be related to ongoing lung injury from COVID.

Eric Adler, MD, a cardiologist with University of San Diego Health, told this news organization that the findings by Dr. Ståhlberg and colleagues are consistent with what he’s seeing in his clinical practice.

Dr. Adler agrees with the authors that tachycardia is an underrecognized complication of long COVID.

He said the article represents further proof that though people may survive COVID, the threat of long-term symptoms, such as heart palpitations, is real and supports the case for vaccinations.

The authors, Dr. Michos, and Dr. Adler have disclosed no relevant financial relationships.

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

Tachycardia is commonly reported in patients with post-acute COVID-19 syndrome (PACS), also known as long COVID, authors report in a new article. The researchers say tachycardia syndrome should be considered a distinct phenotype.

The study by Marcus Ståhlberg, MD, PhD, of Karolinska University Hospital, Stockholm, and colleagues was published online August 11 in The American Journal of Medicine.

Dr. Ståhlberg told this news organization that although much attention has been paid to cases of clotting and perimyocarditis in patients after COVID, relatively little attention has been paid to tachycardia, despite case reports that show that palpitations are a common complaint.

“We have diagnosed a large number of patients with postural orthostatic tachycardia syndrome [POTS] and other forms of COVID-related tachycardia at our post-COVID outpatient clinic at Karolinska University Hospital and wanted to highlight this phenomenon,” he said.

Between 25% and 50% of patients at the clinic report tachycardia and/or palpitations that last 12 weeks or longer, the authors report.

“Systematic investigations suggest that 9% of Post-acute COVID-19 syndrome patients report palpitations at six months,” the authors write.

The findings also shed light on potential tests and treatments, he said.

“Physicians should be liberal in performing a basic cardiological workup, including an ECG [electrocardiogram], echocardiography, and Holter ECG monitoring in patients complaining of palpitations and/or chest pain,” Dr. Ståhlberg said.

“If orthostatic intolerance is also reported – such as vertigo, nausea, dyspnea – suspicion of POTS should be raised and a head-up tilt test or at least an active standing test should be performed,” he said.

If POTS is confirmed, he said, patients should be offered a heart rate–lowering drug, such as low-dose propranolol or ivabradine. Compression garments, increased fluid intake, and a structured rehabilitation program also help.

“According to our clinical experience, ivabradine can also reduce symptoms in patients with inappropriate sinus tachycardia and post-COVID,” Dr. Ståhlberg said. “Another finding on Holter-ECG to look out for is frequent premature extrasystoles, which could indicate myocarditis and should warrant a cardiac MRI.”

Dr. Ståhlberg said the researchers think the mechanism underlying the tachycardia is autoimmune and that primary SARS-CoV-2 infections trigger an autoimmune response with formation of autoantibodies that can activate receptors regulating blood pressure and heart rate.

Long-lasting symptoms from COVID are prevalent, the authors note, especially in patients who experienced severe forms of the disease.

In the longest follow-up study to date of patients hospitalized with COVID, more than 60% experienced fatigue or muscle weakness 6 months after hospitalization.

PACS should not be considered a single syndrome; the term denotes an array of subsyndromes and phenotypes, the authors write. Typical symptoms include headache, fatigue, dyspnea, and mental fog but can involve multiple organs and systems.

Tachycardia can also be used as a marker to help gauge the severity of long COVID, the authors write.

“[T]achycardia can be considered a universal and easily obtainable quantitative marker of Post-acute COVID-19 syndrome and its severity rather than patient-reported symptoms, blood testing, and thoracic CT-scans,” they write.

An underrecognized complication

Erin D. Michos, MD, MHS, director of women’s cardiovascular health and associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview that she has seen many similar symptoms in the long-COVID patients referred to her practice.

Dr. Michos, who is also an associate professor of medicine and epidemiology, said she’s been receiving a “huge number” of referrals of long-COVID patients with postural tachycardia, inappropriate sinus tachycardia, and POTS.

“I think this is all in the spectrum of autonomic dysfunction that has been recognized a lot since COVID. POTS has been thought to have [a potentially] viral cause that triggers an autoimmune response. Even before COVID, many patients had POTS triggered by a viral infection. The question is whether COVID-related POTS for long COVID is different from other kinds of POTS.”

She says she treats long-COVID patients who complain of elevated heart rates with many of the cardiac workup procedures the authors list and that she treats them in a way similar to the way she treats patients with POTS.

She recommends checking resting oxygen levels and having patients walk the halls and measure their oxygen levels after walking, because their elevated heart rate may be related to ongoing lung injury from COVID.

Eric Adler, MD, a cardiologist with University of San Diego Health, told this news organization that the findings by Dr. Ståhlberg and colleagues are consistent with what he’s seeing in his clinical practice.

Dr. Adler agrees with the authors that tachycardia is an underrecognized complication of long COVID.

He said the article represents further proof that though people may survive COVID, the threat of long-term symptoms, such as heart palpitations, is real and supports the case for vaccinations.

The authors, Dr. Michos, and Dr. Adler have disclosed no relevant financial relationships.

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

The FDA has authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems.

The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.

Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.

Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.

“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”

He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”

White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.

The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.

Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.

In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.


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

The FDA has authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems.

The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.

Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.

Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.

“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”

He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”

White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.

The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.

Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.

In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.


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

The FDA has authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems.

The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.

Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.

Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.

“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”

He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”

White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.

The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.

Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.

In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.


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

A nurse in Germany is suspected of giving saline solution rather than the COVID-19 vaccine to more than 8,500 people at a vaccination center this year.

Those who may be affected are being informed about their possible vulnerability to the coronavirus and will be offered COVID-19 shots, according to CBS News.

“I’m totally shocked by the incident,” Sven Ambrosy, a district administrator of Friesland, wrote in a Facebook post on Aug. 10.

“The district of Friesland will do everything possible to ensure that the affected people receive their vaccination protection as soon as possible,” he said.

In late April, a former Red Cross employee who worked at the Roffhausen Vaccination Center in Friesland, a district in Germany’s northern state of Lower Saxony, told a colleague that she filled six syringes with saline instead of the Pfizer vaccine, according to police reports. The nurse said she dropped a vial containing the vaccine while preparing syringes and tried to cover it up.

The nurse was immediately fired, and local authorities conducted antibody tests on more than 100 people who visited the vaccination center on April 21. Since it was impossible to trace who received the saline shots, everyone who visited the center that day was invited to receive a follow-up shot.

But during a police investigation, authorities found evidence that more people were affected. The case now involves 8,557 vaccinations given between March 5 and April 20 at specific times.

Now, authorities are contacting those who were affected by phone or email to schedule new vaccination appointments. They’ve established a dedicated information phone line as well, according to NPR.

Saline solution is harmless, but most people who received shots in Germany during that time were older adults, who are more likely to have severe COVID-19 if infected, according to Reuters.

The nurse has remained silent about the allegations of her giving saline rather than a vaccine to thousands of people, CBS News reported. And it’s unclear whether there have been any arrests or charges related to the case, according to Reuters.

The nurse hasn’t been named publicly, and the motive hasn’t been shared, NPR reported, though the nurse had purportedly expressed skepticism about COVID-19 vaccines in social media posts.

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

A nurse in Germany is suspected of giving saline solution rather than the COVID-19 vaccine to more than 8,500 people at a vaccination center this year.

Those who may be affected are being informed about their possible vulnerability to the coronavirus and will be offered COVID-19 shots, according to CBS News.

“I’m totally shocked by the incident,” Sven Ambrosy, a district administrator of Friesland, wrote in a Facebook post on Aug. 10.

“The district of Friesland will do everything possible to ensure that the affected people receive their vaccination protection as soon as possible,” he said.

In late April, a former Red Cross employee who worked at the Roffhausen Vaccination Center in Friesland, a district in Germany’s northern state of Lower Saxony, told a colleague that she filled six syringes with saline instead of the Pfizer vaccine, according to police reports. The nurse said she dropped a vial containing the vaccine while preparing syringes and tried to cover it up.

The nurse was immediately fired, and local authorities conducted antibody tests on more than 100 people who visited the vaccination center on April 21. Since it was impossible to trace who received the saline shots, everyone who visited the center that day was invited to receive a follow-up shot.

But during a police investigation, authorities found evidence that more people were affected. The case now involves 8,557 vaccinations given between March 5 and April 20 at specific times.

Now, authorities are contacting those who were affected by phone or email to schedule new vaccination appointments. They’ve established a dedicated information phone line as well, according to NPR.

Saline solution is harmless, but most people who received shots in Germany during that time were older adults, who are more likely to have severe COVID-19 if infected, according to Reuters.

The nurse has remained silent about the allegations of her giving saline rather than a vaccine to thousands of people, CBS News reported. And it’s unclear whether there have been any arrests or charges related to the case, according to Reuters.

The nurse hasn’t been named publicly, and the motive hasn’t been shared, NPR reported, though the nurse had purportedly expressed skepticism about COVID-19 vaccines in social media posts.

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

A nurse in Germany is suspected of giving saline solution rather than the COVID-19 vaccine to more than 8,500 people at a vaccination center this year.

Those who may be affected are being informed about their possible vulnerability to the coronavirus and will be offered COVID-19 shots, according to CBS News.

“I’m totally shocked by the incident,” Sven Ambrosy, a district administrator of Friesland, wrote in a Facebook post on Aug. 10.

“The district of Friesland will do everything possible to ensure that the affected people receive their vaccination protection as soon as possible,” he said.

In late April, a former Red Cross employee who worked at the Roffhausen Vaccination Center in Friesland, a district in Germany’s northern state of Lower Saxony, told a colleague that she filled six syringes with saline instead of the Pfizer vaccine, according to police reports. The nurse said she dropped a vial containing the vaccine while preparing syringes and tried to cover it up.

The nurse was immediately fired, and local authorities conducted antibody tests on more than 100 people who visited the vaccination center on April 21. Since it was impossible to trace who received the saline shots, everyone who visited the center that day was invited to receive a follow-up shot.

But during a police investigation, authorities found evidence that more people were affected. The case now involves 8,557 vaccinations given between March 5 and April 20 at specific times.

Now, authorities are contacting those who were affected by phone or email to schedule new vaccination appointments. They’ve established a dedicated information phone line as well, according to NPR.

Saline solution is harmless, but most people who received shots in Germany during that time were older adults, who are more likely to have severe COVID-19 if infected, according to Reuters.

The nurse has remained silent about the allegations of her giving saline rather than a vaccine to thousands of people, CBS News reported. And it’s unclear whether there have been any arrests or charges related to the case, according to Reuters.

The nurse hasn’t been named publicly, and the motive hasn’t been shared, NPR reported, though the nurse had purportedly expressed skepticism about COVID-19 vaccines in social media posts.

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

The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.

Andriy Onufriyenko

“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.

The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.

Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.

As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.

Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.  

Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.

“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.

That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.

“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
 

Hospitals ‘under great stress’

In a setting where most Americans now have access to safe and highly effective vaccines, hospitals in the Southeast are once again under siege from COVID-19.

Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.

COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.

“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore

The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.

Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.

“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”

Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”

She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”

“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.

Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people. 

“That’s the best scenario,” he said.

If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.

Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.

“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
 

‘Sense of betrayal’

Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.

In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge. 

Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.

Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.

“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”

“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”

Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”

Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.

At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.

“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.

Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.

“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.

Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.

The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.

“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.

“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.

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

The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.

Andriy Onufriyenko

“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.

The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.

Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.

As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.

Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.  

Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.

“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.

That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.

“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
 

Hospitals ‘under great stress’

In a setting where most Americans now have access to safe and highly effective vaccines, hospitals in the Southeast are once again under siege from COVID-19.

Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.

COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.

“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore

The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.

Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.

“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”

Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”

She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”

“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.

Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people. 

“That’s the best scenario,” he said.

If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.

Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.

“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
 

‘Sense of betrayal’

Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.

In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge. 

Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.

Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.

“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”

“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”

Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”

Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.

At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.

“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.

Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.

“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.

Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.

The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.

“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.

“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.

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

The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.

Andriy Onufriyenko

“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.

The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.

Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.

As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.

Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.  

Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.

“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.

That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.

“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
 

Hospitals ‘under great stress’

In a setting where most Americans now have access to safe and highly effective vaccines, hospitals in the Southeast are once again under siege from COVID-19.

Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.

COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.

“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore

The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.

Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.

“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”

Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”

She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”

“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.

Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people. 

“That’s the best scenario,” he said.

If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.

Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.

“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
 

‘Sense of betrayal’

Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.

In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge. 

Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.

Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.

“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”

“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”

Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”

Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.

At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.

“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.

Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.

“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.

Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.

The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.

“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.

“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.

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