Infectious Diseases

Regulators and the nation’s largest physician organization took separate steps in recent days to prepare for expected authorization of use of COVID-19 vaccines in children younger than age 6.

The Food and Drug Administration on May 23 announced its Vaccines and Related Biological Products Advisory Committee will meet June 15 to discuss expanding the use of COVID vaccines from Pfizer and Moderna.

The panel will examine a request from Pfizer and its partner BioNTech for an emergency use authorization (EUA) of its vaccine to cover children ages 6 months through 4 years. The EUA expansion for the Moderna shot would cover children ages 6 months through 5 years, the FDA said.

Many parents and physicians have been urging regulators to clear COVID shots for young children, among whom rates of infection are high.

The American Medical Association in February announced an update of its Current Procedural Terminology (CPT) to prepare for an eventual FDA clearance of the Pfizer-BioNTech shot for children aged 6 months to younger than 5 years. On May 19, the association announced a new CPT update to prepare for FDA clearance for use of the Moderna COVID-19 vaccine for children 6 months through 5 years.

“Extending COVID-19 vaccination protection to approximately 18 million young children will significantly reduce their risk of COVID-19 infection, hospitalization, and death, and give their parents incredible peace of mind,” Gerald Harmon, MD, AMA’s president, said in a statement. “We strongly urge all parents to get their infants and toddlers vaccinated as soon as they are eligible for a COVID-19 vaccine.”

Both the Moderna and the Pfizer-BioNTech COVID vaccines would be given to these young children in low doses.

On May 23, Pfizer announced results from a phase 2/3 trial evaluating a series of three shots of its vaccine in children ages 6 months to younger than 5 years.

Vaccine efficacy, which was a secondary endpoint in this study, was 80.3% in this age group, Pfizer said. The analysis was based on 10 symptomatic cases of COVID-19. The trial’s protocol specifies a formal analysis will be performed when at least 21 cases have accrued from 7 days after the third dose. The company said it would share final data on the effectiveness of the vaccine once the results are available.

Moderna on April 28 issued a statement with details about testing of its vaccine in young children. Vaccine efficacy was estimated at about 51% for children aged 6 months to younger than 2 years and 37% for the children aged 2 years to younger than 6. Paul Burton, MD, Moderna’s chief medical officer, spoke about this rate during a May 1 appearance on CBS’ Face the Nation.

“What it means for parents, for caregivers, is that if they give the Moderna vaccine to these little kids, they would basically cut in half the risk of that child getting symptomatic COVID,” Dr. Burton said in the interview. “Now, the number, 50%, I know is often lower than we are used to seeing with our vaccine, but it’s because this study was conducted during a time of Omicron.”

The FDA’s vaccine advisory committee also will meet on June 14 discuss potential use under an EUA of Moderna’s COVID vaccine for children and teenagers aged 6-17 years. The Pfizer-BioNTech vaccine already is authorized under an EUA for people aged 5 years and older.

The FDA has to date granted both conditional clearances, or EUAs, and regular approvals for COVID vaccines.

EUAs are meant to be temporary, allowing for rapid introduction of medicines in response to public health crises such as the pandemic. The FDA also uses EUAs to provide initial clearances of additional indications for products, as would be the case with the authorizations Moderna and Pfizer-BioNTech are seeking for their COVID vaccines.

Companies that want to continue to sell EUA-cleared products or promote EUA-cleared indications beyond the time of the public health crisis must seek regular approvals.

The FDA cleared the Pfizer-BioNTech and Moderna COVID vaccines under EUAs in December 2020. The agency then granted a regular approval for the Pfizer-BioNTech vaccine for people ages 16 and older in August 2021 based on more robust data. Regular approval for the Moderna vaccine for people ages 18 and older followed in January 2022.
 

Varied reactions among parents

Attitudes in the United States about pediatric COVID vaccines are far from uniform.

The initial uptake has disappointed physicians and researchers, who have been urging wider use of the COVID vaccination among children and teens for whom the FDA already has granted a clearance. Many parents are hesitating to bring their children for the COVID vaccines, according to the Centers for Disease Control and Prevention. Only 35.4% of children ages 5-11 had received at least one dose of a COVID vaccine, CDC staff said during a meeting.

Yet many other parents are demanding this medicine for their young children, urging the FDA to move quickly to clear COVID shots.

A private Facebook group called “Protect Their Future: A Call to Action for COVID Vaccines in Kids <5” boasts about 6,200 members. Many parents and physicians have used Twitter in recent months to press for a speedy review of COVID vaccines for the youngest children, often using the hashtag #immunizeunder5s. A group called Protect Their Future, which uses @ImmunizeUnder5s as its Twitter handle, had 5,288 followers as of the afternoon of May 23.

A special panel of the House of Representatives, the Select Subcommittee on the Coronavirus Crisis, on May 23 joined those tweeting about the need to soon authorize COVID vaccines for very young children.

“Parents have been waiting many months for vaccines for their young children,” the subcommittee tweeted. “They deserve to hear from @US_FDA why this lengthy process has been in children’s best interests.”

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

Regulators and the nation’s largest physician organization took separate steps in recent days to prepare for expected authorization of use of COVID-19 vaccines in children younger than age 6.

The Food and Drug Administration on May 23 announced its Vaccines and Related Biological Products Advisory Committee will meet June 15 to discuss expanding the use of COVID vaccines from Pfizer and Moderna.

The panel will examine a request from Pfizer and its partner BioNTech for an emergency use authorization (EUA) of its vaccine to cover children ages 6 months through 4 years. The EUA expansion for the Moderna shot would cover children ages 6 months through 5 years, the FDA said.

Many parents and physicians have been urging regulators to clear COVID shots for young children, among whom rates of infection are high.

The American Medical Association in February announced an update of its Current Procedural Terminology (CPT) to prepare for an eventual FDA clearance of the Pfizer-BioNTech shot for children aged 6 months to younger than 5 years. On May 19, the association announced a new CPT update to prepare for FDA clearance for use of the Moderna COVID-19 vaccine for children 6 months through 5 years.

“Extending COVID-19 vaccination protection to approximately 18 million young children will significantly reduce their risk of COVID-19 infection, hospitalization, and death, and give their parents incredible peace of mind,” Gerald Harmon, MD, AMA’s president, said in a statement. “We strongly urge all parents to get their infants and toddlers vaccinated as soon as they are eligible for a COVID-19 vaccine.”

Both the Moderna and the Pfizer-BioNTech COVID vaccines would be given to these young children in low doses.

On May 23, Pfizer announced results from a phase 2/3 trial evaluating a series of three shots of its vaccine in children ages 6 months to younger than 5 years.

Vaccine efficacy, which was a secondary endpoint in this study, was 80.3% in this age group, Pfizer said. The analysis was based on 10 symptomatic cases of COVID-19. The trial’s protocol specifies a formal analysis will be performed when at least 21 cases have accrued from 7 days after the third dose. The company said it would share final data on the effectiveness of the vaccine once the results are available.

Moderna on April 28 issued a statement with details about testing of its vaccine in young children. Vaccine efficacy was estimated at about 51% for children aged 6 months to younger than 2 years and 37% for the children aged 2 years to younger than 6. Paul Burton, MD, Moderna’s chief medical officer, spoke about this rate during a May 1 appearance on CBS’ Face the Nation.

“What it means for parents, for caregivers, is that if they give the Moderna vaccine to these little kids, they would basically cut in half the risk of that child getting symptomatic COVID,” Dr. Burton said in the interview. “Now, the number, 50%, I know is often lower than we are used to seeing with our vaccine, but it’s because this study was conducted during a time of Omicron.”

The FDA’s vaccine advisory committee also will meet on June 14 discuss potential use under an EUA of Moderna’s COVID vaccine for children and teenagers aged 6-17 years. The Pfizer-BioNTech vaccine already is authorized under an EUA for people aged 5 years and older.

The FDA has to date granted both conditional clearances, or EUAs, and regular approvals for COVID vaccines.

EUAs are meant to be temporary, allowing for rapid introduction of medicines in response to public health crises such as the pandemic. The FDA also uses EUAs to provide initial clearances of additional indications for products, as would be the case with the authorizations Moderna and Pfizer-BioNTech are seeking for their COVID vaccines.

Companies that want to continue to sell EUA-cleared products or promote EUA-cleared indications beyond the time of the public health crisis must seek regular approvals.

The FDA cleared the Pfizer-BioNTech and Moderna COVID vaccines under EUAs in December 2020. The agency then granted a regular approval for the Pfizer-BioNTech vaccine for people ages 16 and older in August 2021 based on more robust data. Regular approval for the Moderna vaccine for people ages 18 and older followed in January 2022.
 

Varied reactions among parents

Attitudes in the United States about pediatric COVID vaccines are far from uniform.

The initial uptake has disappointed physicians and researchers, who have been urging wider use of the COVID vaccination among children and teens for whom the FDA already has granted a clearance. Many parents are hesitating to bring their children for the COVID vaccines, according to the Centers for Disease Control and Prevention. Only 35.4% of children ages 5-11 had received at least one dose of a COVID vaccine, CDC staff said during a meeting.

Yet many other parents are demanding this medicine for their young children, urging the FDA to move quickly to clear COVID shots.

A private Facebook group called “Protect Their Future: A Call to Action for COVID Vaccines in Kids <5” boasts about 6,200 members. Many parents and physicians have used Twitter in recent months to press for a speedy review of COVID vaccines for the youngest children, often using the hashtag #immunizeunder5s. A group called Protect Their Future, which uses @ImmunizeUnder5s as its Twitter handle, had 5,288 followers as of the afternoon of May 23.

A special panel of the House of Representatives, the Select Subcommittee on the Coronavirus Crisis, on May 23 joined those tweeting about the need to soon authorize COVID vaccines for very young children.

“Parents have been waiting many months for vaccines for their young children,” the subcommittee tweeted. “They deserve to hear from @US_FDA why this lengthy process has been in children’s best interests.”

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

Regulators and the nation’s largest physician organization took separate steps in recent days to prepare for expected authorization of use of COVID-19 vaccines in children younger than age 6.

The Food and Drug Administration on May 23 announced its Vaccines and Related Biological Products Advisory Committee will meet June 15 to discuss expanding the use of COVID vaccines from Pfizer and Moderna.

The panel will examine a request from Pfizer and its partner BioNTech for an emergency use authorization (EUA) of its vaccine to cover children ages 6 months through 4 years. The EUA expansion for the Moderna shot would cover children ages 6 months through 5 years, the FDA said.

Many parents and physicians have been urging regulators to clear COVID shots for young children, among whom rates of infection are high.

The American Medical Association in February announced an update of its Current Procedural Terminology (CPT) to prepare for an eventual FDA clearance of the Pfizer-BioNTech shot for children aged 6 months to younger than 5 years. On May 19, the association announced a new CPT update to prepare for FDA clearance for use of the Moderna COVID-19 vaccine for children 6 months through 5 years.

“Extending COVID-19 vaccination protection to approximately 18 million young children will significantly reduce their risk of COVID-19 infection, hospitalization, and death, and give their parents incredible peace of mind,” Gerald Harmon, MD, AMA’s president, said in a statement. “We strongly urge all parents to get their infants and toddlers vaccinated as soon as they are eligible for a COVID-19 vaccine.”

Both the Moderna and the Pfizer-BioNTech COVID vaccines would be given to these young children in low doses.

On May 23, Pfizer announced results from a phase 2/3 trial evaluating a series of three shots of its vaccine in children ages 6 months to younger than 5 years.

Vaccine efficacy, which was a secondary endpoint in this study, was 80.3% in this age group, Pfizer said. The analysis was based on 10 symptomatic cases of COVID-19. The trial’s protocol specifies a formal analysis will be performed when at least 21 cases have accrued from 7 days after the third dose. The company said it would share final data on the effectiveness of the vaccine once the results are available.

Moderna on April 28 issued a statement with details about testing of its vaccine in young children. Vaccine efficacy was estimated at about 51% for children aged 6 months to younger than 2 years and 37% for the children aged 2 years to younger than 6. Paul Burton, MD, Moderna’s chief medical officer, spoke about this rate during a May 1 appearance on CBS’ Face the Nation.

“What it means for parents, for caregivers, is that if they give the Moderna vaccine to these little kids, they would basically cut in half the risk of that child getting symptomatic COVID,” Dr. Burton said in the interview. “Now, the number, 50%, I know is often lower than we are used to seeing with our vaccine, but it’s because this study was conducted during a time of Omicron.”

The FDA’s vaccine advisory committee also will meet on June 14 discuss potential use under an EUA of Moderna’s COVID vaccine for children and teenagers aged 6-17 years. The Pfizer-BioNTech vaccine already is authorized under an EUA for people aged 5 years and older.

The FDA has to date granted both conditional clearances, or EUAs, and regular approvals for COVID vaccines.

EUAs are meant to be temporary, allowing for rapid introduction of medicines in response to public health crises such as the pandemic. The FDA also uses EUAs to provide initial clearances of additional indications for products, as would be the case with the authorizations Moderna and Pfizer-BioNTech are seeking for their COVID vaccines.

Companies that want to continue to sell EUA-cleared products or promote EUA-cleared indications beyond the time of the public health crisis must seek regular approvals.

The FDA cleared the Pfizer-BioNTech and Moderna COVID vaccines under EUAs in December 2020. The agency then granted a regular approval for the Pfizer-BioNTech vaccine for people ages 16 and older in August 2021 based on more robust data. Regular approval for the Moderna vaccine for people ages 18 and older followed in January 2022.
 

Varied reactions among parents

Attitudes in the United States about pediatric COVID vaccines are far from uniform.

The initial uptake has disappointed physicians and researchers, who have been urging wider use of the COVID vaccination among children and teens for whom the FDA already has granted a clearance. Many parents are hesitating to bring their children for the COVID vaccines, according to the Centers for Disease Control and Prevention. Only 35.4% of children ages 5-11 had received at least one dose of a COVID vaccine, CDC staff said during a meeting.

Yet many other parents are demanding this medicine for their young children, urging the FDA to move quickly to clear COVID shots.

A private Facebook group called “Protect Their Future: A Call to Action for COVID Vaccines in Kids <5” boasts about 6,200 members. Many parents and physicians have used Twitter in recent months to press for a speedy review of COVID vaccines for the youngest children, often using the hashtag #immunizeunder5s. A group called Protect Their Future, which uses @ImmunizeUnder5s as its Twitter handle, had 5,288 followers as of the afternoon of May 23.

A special panel of the House of Representatives, the Select Subcommittee on the Coronavirus Crisis, on May 23 joined those tweeting about the need to soon authorize COVID vaccines for very young children.

“Parents have been waiting many months for vaccines for their young children,” the subcommittee tweeted. “They deserve to hear from @US_FDA why this lengthy process has been in children’s best interests.”

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

President Joe Biden said Monday that he didn’t believe quarantines to prevent the spread of monkeypox in the United States would be necessary.

He said the United States has enough vaccine doses available to stop any serious outbreaks and to “deal with the likelihood of the problem,” according to The Washington Post .

“I just don’t think it rises to the level of the kind of concern that existed with COVID-19, and the smallpox vaccine works for it,” Biden said during a news conference in Japan.

The World Health Organization has identified monkeypox cases in at least a dozen countries where the disease isn’t typically considered endemic. Generally found in Central and West Africa, the illness has been reported in several European countries, as well as the United States, Canada, and Australia.

On Sunday, Biden told reporters that monkeypox is a “concern in that if it were to spread, it would be consequential.” Administration officials have said the president has been briefed on the disease, the newspaper reported.

Monkeypox spreads through droplets and bodily fluids but doesn’t pass easily between humans and is less contagious than the coronavirus, the Post reported. The CDC has reported that the smallpox vaccine is 85% effective against monkeypox, and the U.S. has licensed two smallpox vaccines that could help in potential outbreaks, including one that specifically targets monkeypox.

Mandatory monkeypox quarantine in Belgium

Belgium is the first country to put a mandatory 21-day quarantine in place for monkeypox patients as cases spread globally, according to CNBC. Health authorities announced the quarantine on Friday after the country recorded its third case.

The quarantine only applies to patients with a confirmed infection. Close contacts aren’t required to self-isolate but are encouraged to be careful and watch for symptoms, especially if they spend time with vulnerable people who could contract a serious illness, CNBC reported.

The United Kingdom has published guidelines to assess risks of monkeypox infection and provide guidance on self-isolation and monitoring. Health officials have said that those who have high exposure risks should self-isolate for 21 days, which includes household contacts or medical professionals who have worked with infected patients.

As of Saturday, the WHO has received reports of 92 confirmed monkeypox cases and 28 suspected cases across 12 countries where the virus isn’t typically found. No deaths linked to the cases have been reported so far.

The outbreaks have caused concern among health officials because most cases don’t have travel links to endemic countries. So far, many cases have spread between men who have sex with men, and the cases have been identified as patients seek care in primary care and sexual health clinics, the WHO reported.

“The identification of confirmed and suspected cases of monkeypox with no direct travel links to an endemic area represents a highly unusual event,” the WHO said. “Available information suggests that human-to-human transmission is occurring among people in close physical contact with cases who are symptomatic.”

White House health official doesn’t foresee major outbreak

Ashish Jha, MD, a top Biden administration health official who serves as the White House COVID-19 response coordinator, said Sunday that he doesn’t expect monkeypox to have widespread effects in the U.S.

“I feel like this is a virus we understand,” he said on ABC News’s This Week.

The virus has been monitored for decades, and there are treatments for it, Dr. Jha said.

“We have vaccines against it. We have treatments against it,” he said. “It’s not as contagious as COVID. So, I am confident we’re going to be able to keep our arms around it.”

At the same time, Dr. Jha agreed that health officials should keep an eye on the situation. Cases have been confirmed in recent days in several countries, as well as the United States.

“I would not be surprised if we see a few more cases in the upcoming days,” he said. “Any time we have an infectious outbreak like this, we should all be paying attention.”

Dr. Jha also stressed ongoing caution amid the COVID-19 pandemic as cases once again surpass 100,000 daily infections. Variants will continue to evolve, he said, and ongoing outbreaks will reinfect people who have been vaccinated or had a previous infection.

“What we know is that this virus is evolving very quickly, and every iteration of it has more and more immune escape,” he said. “That makes it harder for this virus to be contained unless we continue vaccinating people and keeping people up to date.”

Third possible U.S. monkeypox case found in Florida

The CDC said Sunday that it may have found a third monkeypox case in the United States and is running tests on a patient in South Florida, according to Reuters.

The person is in Broward County and remains isolated. The case appears to be related to international travel, the CDC told Reuters.

Health officials are doing tests to confirm if the patient has the disease, with results expected “soon.” No other cases have been identified in Florida so far.

The first monkeypox case in the United States was reported in Massachusetts last week. The patient had recently traveled to Canada.

The second U.S. case was reported in a New York City resident who tested positive on Friday.

The disease, which is like human smallpox but milder, is a viral infection that was first found in the Democratic Republic of Congo in the 1970s. Symptoms include fever, headaches, and a skin rash across the body.


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

President Joe Biden said Monday that he didn’t believe quarantines to prevent the spread of monkeypox in the United States would be necessary.

He said the United States has enough vaccine doses available to stop any serious outbreaks and to “deal with the likelihood of the problem,” according to The Washington Post .

“I just don’t think it rises to the level of the kind of concern that existed with COVID-19, and the smallpox vaccine works for it,” Biden said during a news conference in Japan.

The World Health Organization has identified monkeypox cases in at least a dozen countries where the disease isn’t typically considered endemic. Generally found in Central and West Africa, the illness has been reported in several European countries, as well as the United States, Canada, and Australia.

On Sunday, Biden told reporters that monkeypox is a “concern in that if it were to spread, it would be consequential.” Administration officials have said the president has been briefed on the disease, the newspaper reported.

Monkeypox spreads through droplets and bodily fluids but doesn’t pass easily between humans and is less contagious than the coronavirus, the Post reported. The CDC has reported that the smallpox vaccine is 85% effective against monkeypox, and the U.S. has licensed two smallpox vaccines that could help in potential outbreaks, including one that specifically targets monkeypox.

Mandatory monkeypox quarantine in Belgium

Belgium is the first country to put a mandatory 21-day quarantine in place for monkeypox patients as cases spread globally, according to CNBC. Health authorities announced the quarantine on Friday after the country recorded its third case.

The quarantine only applies to patients with a confirmed infection. Close contacts aren’t required to self-isolate but are encouraged to be careful and watch for symptoms, especially if they spend time with vulnerable people who could contract a serious illness, CNBC reported.

The United Kingdom has published guidelines to assess risks of monkeypox infection and provide guidance on self-isolation and monitoring. Health officials have said that those who have high exposure risks should self-isolate for 21 days, which includes household contacts or medical professionals who have worked with infected patients.

As of Saturday, the WHO has received reports of 92 confirmed monkeypox cases and 28 suspected cases across 12 countries where the virus isn’t typically found. No deaths linked to the cases have been reported so far.

The outbreaks have caused concern among health officials because most cases don’t have travel links to endemic countries. So far, many cases have spread between men who have sex with men, and the cases have been identified as patients seek care in primary care and sexual health clinics, the WHO reported.

“The identification of confirmed and suspected cases of monkeypox with no direct travel links to an endemic area represents a highly unusual event,” the WHO said. “Available information suggests that human-to-human transmission is occurring among people in close physical contact with cases who are symptomatic.”

White House health official doesn’t foresee major outbreak

Ashish Jha, MD, a top Biden administration health official who serves as the White House COVID-19 response coordinator, said Sunday that he doesn’t expect monkeypox to have widespread effects in the U.S.

“I feel like this is a virus we understand,” he said on ABC News’s This Week.

The virus has been monitored for decades, and there are treatments for it, Dr. Jha said.

“We have vaccines against it. We have treatments against it,” he said. “It’s not as contagious as COVID. So, I am confident we’re going to be able to keep our arms around it.”

At the same time, Dr. Jha agreed that health officials should keep an eye on the situation. Cases have been confirmed in recent days in several countries, as well as the United States.

“I would not be surprised if we see a few more cases in the upcoming days,” he said. “Any time we have an infectious outbreak like this, we should all be paying attention.”

Dr. Jha also stressed ongoing caution amid the COVID-19 pandemic as cases once again surpass 100,000 daily infections. Variants will continue to evolve, he said, and ongoing outbreaks will reinfect people who have been vaccinated or had a previous infection.

“What we know is that this virus is evolving very quickly, and every iteration of it has more and more immune escape,” he said. “That makes it harder for this virus to be contained unless we continue vaccinating people and keeping people up to date.”

Third possible U.S. monkeypox case found in Florida

The CDC said Sunday that it may have found a third monkeypox case in the United States and is running tests on a patient in South Florida, according to Reuters.

The person is in Broward County and remains isolated. The case appears to be related to international travel, the CDC told Reuters.

Health officials are doing tests to confirm if the patient has the disease, with results expected “soon.” No other cases have been identified in Florida so far.

The first monkeypox case in the United States was reported in Massachusetts last week. The patient had recently traveled to Canada.

The second U.S. case was reported in a New York City resident who tested positive on Friday.

The disease, which is like human smallpox but milder, is a viral infection that was first found in the Democratic Republic of Congo in the 1970s. Symptoms include fever, headaches, and a skin rash across the body.


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

President Joe Biden said Monday that he didn’t believe quarantines to prevent the spread of monkeypox in the United States would be necessary.

He said the United States has enough vaccine doses available to stop any serious outbreaks and to “deal with the likelihood of the problem,” according to The Washington Post .

“I just don’t think it rises to the level of the kind of concern that existed with COVID-19, and the smallpox vaccine works for it,” Biden said during a news conference in Japan.

The World Health Organization has identified monkeypox cases in at least a dozen countries where the disease isn’t typically considered endemic. Generally found in Central and West Africa, the illness has been reported in several European countries, as well as the United States, Canada, and Australia.

On Sunday, Biden told reporters that monkeypox is a “concern in that if it were to spread, it would be consequential.” Administration officials have said the president has been briefed on the disease, the newspaper reported.

Monkeypox spreads through droplets and bodily fluids but doesn’t pass easily between humans and is less contagious than the coronavirus, the Post reported. The CDC has reported that the smallpox vaccine is 85% effective against monkeypox, and the U.S. has licensed two smallpox vaccines that could help in potential outbreaks, including one that specifically targets monkeypox.

Mandatory monkeypox quarantine in Belgium

Belgium is the first country to put a mandatory 21-day quarantine in place for monkeypox patients as cases spread globally, according to CNBC. Health authorities announced the quarantine on Friday after the country recorded its third case.

The quarantine only applies to patients with a confirmed infection. Close contacts aren’t required to self-isolate but are encouraged to be careful and watch for symptoms, especially if they spend time with vulnerable people who could contract a serious illness, CNBC reported.

The United Kingdom has published guidelines to assess risks of monkeypox infection and provide guidance on self-isolation and monitoring. Health officials have said that those who have high exposure risks should self-isolate for 21 days, which includes household contacts or medical professionals who have worked with infected patients.

As of Saturday, the WHO has received reports of 92 confirmed monkeypox cases and 28 suspected cases across 12 countries where the virus isn’t typically found. No deaths linked to the cases have been reported so far.

The outbreaks have caused concern among health officials because most cases don’t have travel links to endemic countries. So far, many cases have spread between men who have sex with men, and the cases have been identified as patients seek care in primary care and sexual health clinics, the WHO reported.

“The identification of confirmed and suspected cases of monkeypox with no direct travel links to an endemic area represents a highly unusual event,” the WHO said. “Available information suggests that human-to-human transmission is occurring among people in close physical contact with cases who are symptomatic.”

White House health official doesn’t foresee major outbreak

Ashish Jha, MD, a top Biden administration health official who serves as the White House COVID-19 response coordinator, said Sunday that he doesn’t expect monkeypox to have widespread effects in the U.S.

“I feel like this is a virus we understand,” he said on ABC News’s This Week.

The virus has been monitored for decades, and there are treatments for it, Dr. Jha said.

“We have vaccines against it. We have treatments against it,” he said. “It’s not as contagious as COVID. So, I am confident we’re going to be able to keep our arms around it.”

At the same time, Dr. Jha agreed that health officials should keep an eye on the situation. Cases have been confirmed in recent days in several countries, as well as the United States.

“I would not be surprised if we see a few more cases in the upcoming days,” he said. “Any time we have an infectious outbreak like this, we should all be paying attention.”

Dr. Jha also stressed ongoing caution amid the COVID-19 pandemic as cases once again surpass 100,000 daily infections. Variants will continue to evolve, he said, and ongoing outbreaks will reinfect people who have been vaccinated or had a previous infection.

“What we know is that this virus is evolving very quickly, and every iteration of it has more and more immune escape,” he said. “That makes it harder for this virus to be contained unless we continue vaccinating people and keeping people up to date.”

Third possible U.S. monkeypox case found in Florida

The CDC said Sunday that it may have found a third monkeypox case in the United States and is running tests on a patient in South Florida, according to Reuters.

The person is in Broward County and remains isolated. The case appears to be related to international travel, the CDC told Reuters.

Health officials are doing tests to confirm if the patient has the disease, with results expected “soon.” No other cases have been identified in Florida so far.

The first monkeypox case in the United States was reported in Massachusetts last week. The patient had recently traveled to Canada.

The second U.S. case was reported in a New York City resident who tested positive on Friday.

The disease, which is like human smallpox but milder, is a viral infection that was first found in the Democratic Republic of Congo in the 1970s. Symptoms include fever, headaches, and a skin rash across the body.


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

NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.

Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.

“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.

However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”

“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”

As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.

Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).

The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).

Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).

Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.

Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”

Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”

“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”

Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”

“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
 

Reuters Health Information © 2022

NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.

Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.

“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.

However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”

“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”

As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.

Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).

The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).

Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).

Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.

Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”

Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”

“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”

Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”

“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
 

Reuters Health Information © 2022

NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.

Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.

“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.

However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”

“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”

As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.

Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).

The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).

Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).

Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.

Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”

Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”

“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”

Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”

“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
 

Reuters Health Information © 2022

Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

• Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
• Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
• Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
• Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
• Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

• Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
• Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
• Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
• Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
• Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

• Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
• Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
• Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
• Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
• Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

Each year, there are about 59,000 deaths from rabies globally. Most of these occur outside the United States and are the result of dog bites. Since infection with rabies is almost always fatal, there has been considerable attention given to vaccinating people at high risk before likely exposure and responding immediately to those bitten by a rabid animal.

The Centers for Disease Control and Prevention recently revised its preexposure prophylaxis (PrEP) recommendations for rabies. Under the previous 2008 guidelines, PrEP injections were given on days 0, 7, and 21 and cost more than $1,100. In trying to simplify recommendations and make immunization less expensive, the agency designated five risk levels with different advice based on the level of risk.

The first two groups are those with very high risk of occupational exposures – either working with rabies virus in the laboratory or working with or having contact with bats or performing animal necropsies. They are now advised to get two doses of rabies vaccine on days 0 and 7. The lab workers should have titers checked every 6 months to ensure that they remain adequately protected. And a booster should be given if the titer drops to < 0.5 IU/mL. The second group, with bat exposures, should have titers checked every 2 years.

Risk category 3 is those with long-term (> 3 years) exposure to mammals other than bats that might be rabid. This group would include veterinarians, wildlife biologists, animal control officers, and spelunkers (cavers). Category 3 also includes travelers who may encounter rabid dogs, which is not a risk in the United States. They would get the same initial two doses. The new recommendations for a third dose are based either on a titer drawn 1-3 years later being < 0.5 IU/mL or choosing to give a booster between 3 weeks and 3 years after the second dose.

The same groups are covered in risk group 4, but these are expected to have less than 3 years of potential exposure after PrEP. They would receive two doses on days 0 and 7.

Finally, group 5, at the lowest risk, includes most of the U.S. population. They do not require any PrEP.

Agam Rao, MD, CAPT, U.S. Public Health Service, CDC, told this news organization that the CDC’s Advisory Committee on Immunization Practices (ACIP) has been working on updating the 2008 rabies PrEP recommendations for several years. The committee wanted the new guideline to be “as easily followable as possible but also based on the evidence itself.”

There were two significant problems the committee tried to address. “One was that travelers who book their travel on kind of short notice don’t have enough time to get that third dose, which at the earliest can be given on day 21,” Dr. Rao said.

The second problem is that “a three-dose series [is] just really expensive. And what we found from data that had been published since the last ACIP recommendations is that fewer people than we recommend get vaccinated were getting vaccinated. So hopefully, the two-dose series helps with that.”

The ACIP used an adapted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to determine the certainty of the evidence for immunogenicity. The ACIP also used an evidence to recommendations (EtR) framework. “This incorporates a lot of other factors like the acceptability, usability, equity, all of these other variables that are important to the evidence being translated into recommendations,” Dr. Rao said. A table details their analysis.

Rabies expert Thiravat Hemachudha, MD, professor of neurology at WHO Collaborating Centre for Research and Training on Viral Zoonoses, Chulalongkorn University Hospital, Bangkok, told this news organization via email that “the ACIP relies mostly on serology, whereas the rest of the world cannot afford the test or testing may not be available.”

He added: “The issue of ‘long-term immunogenicity’ after receiving [PrEP is] an anamnestic response. All standard tissue culture rabies vaccines with appropriate dosage and route of delivery, either IM or ID, are considered safe and effective. There are many studies in Asian countries confirming that with only one primary series of PrEP, ID or IM with reduced doses, can produce immunity for as long as 20 years. Therefore, serology check is not necessary in general populations in rabies endemic countries where most of the rabies deaths occur. Investigation of all death cases was performed in Thailand and did not reveal any failure. Cases with PrEP in the past who died did not receive a booster after exposure.”

Dr. Rao offered one additional suggestion to clinicians faced with an urgent need to get a rabies titer: “They really should reach out to the lab (with all the information) before they send the specimen for the titer check ... so that the testing can be facilitated. All of these laboratories have the capacity to do stat and ASAP testing ... Clinicians do not know that they can call laboratories directly and expedite this sort of testing.” 

Dr. Rao emphasized that PrEP does not eliminate the need for postexposure prophylaxis (PEP). Still, it eliminates the need for rabies immunoglobulin and decreases the number of vaccine doses required for PEP. “I hope more people will take advantage of the titer checks and potentially save the patient some money,” she concluded.

Dr. Rao and Dr. Hemachudha have disclosed no relevant financial relationships.

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

Each year, there are about 59,000 deaths from rabies globally. Most of these occur outside the United States and are the result of dog bites. Since infection with rabies is almost always fatal, there has been considerable attention given to vaccinating people at high risk before likely exposure and responding immediately to those bitten by a rabid animal.

The Centers for Disease Control and Prevention recently revised its preexposure prophylaxis (PrEP) recommendations for rabies. Under the previous 2008 guidelines, PrEP injections were given on days 0, 7, and 21 and cost more than $1,100. In trying to simplify recommendations and make immunization less expensive, the agency designated five risk levels with different advice based on the level of risk.

The first two groups are those with very high risk of occupational exposures – either working with rabies virus in the laboratory or working with or having contact with bats or performing animal necropsies. They are now advised to get two doses of rabies vaccine on days 0 and 7. The lab workers should have titers checked every 6 months to ensure that they remain adequately protected. And a booster should be given if the titer drops to < 0.5 IU/mL. The second group, with bat exposures, should have titers checked every 2 years.

Risk category 3 is those with long-term (> 3 years) exposure to mammals other than bats that might be rabid. This group would include veterinarians, wildlife biologists, animal control officers, and spelunkers (cavers). Category 3 also includes travelers who may encounter rabid dogs, which is not a risk in the United States. They would get the same initial two doses. The new recommendations for a third dose are based either on a titer drawn 1-3 years later being < 0.5 IU/mL or choosing to give a booster between 3 weeks and 3 years after the second dose.

The same groups are covered in risk group 4, but these are expected to have less than 3 years of potential exposure after PrEP. They would receive two doses on days 0 and 7.

Finally, group 5, at the lowest risk, includes most of the U.S. population. They do not require any PrEP.

Agam Rao, MD, CAPT, U.S. Public Health Service, CDC, told this news organization that the CDC’s Advisory Committee on Immunization Practices (ACIP) has been working on updating the 2008 rabies PrEP recommendations for several years. The committee wanted the new guideline to be “as easily followable as possible but also based on the evidence itself.”

There were two significant problems the committee tried to address. “One was that travelers who book their travel on kind of short notice don’t have enough time to get that third dose, which at the earliest can be given on day 21,” Dr. Rao said.

The second problem is that “a three-dose series [is] just really expensive. And what we found from data that had been published since the last ACIP recommendations is that fewer people than we recommend get vaccinated were getting vaccinated. So hopefully, the two-dose series helps with that.”

The ACIP used an adapted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to determine the certainty of the evidence for immunogenicity. The ACIP also used an evidence to recommendations (EtR) framework. “This incorporates a lot of other factors like the acceptability, usability, equity, all of these other variables that are important to the evidence being translated into recommendations,” Dr. Rao said. A table details their analysis.

Rabies expert Thiravat Hemachudha, MD, professor of neurology at WHO Collaborating Centre for Research and Training on Viral Zoonoses, Chulalongkorn University Hospital, Bangkok, told this news organization via email that “the ACIP relies mostly on serology, whereas the rest of the world cannot afford the test or testing may not be available.”

He added: “The issue of ‘long-term immunogenicity’ after receiving [PrEP is] an anamnestic response. All standard tissue culture rabies vaccines with appropriate dosage and route of delivery, either IM or ID, are considered safe and effective. There are many studies in Asian countries confirming that with only one primary series of PrEP, ID or IM with reduced doses, can produce immunity for as long as 20 years. Therefore, serology check is not necessary in general populations in rabies endemic countries where most of the rabies deaths occur. Investigation of all death cases was performed in Thailand and did not reveal any failure. Cases with PrEP in the past who died did not receive a booster after exposure.”

Dr. Rao offered one additional suggestion to clinicians faced with an urgent need to get a rabies titer: “They really should reach out to the lab (with all the information) before they send the specimen for the titer check ... so that the testing can be facilitated. All of these laboratories have the capacity to do stat and ASAP testing ... Clinicians do not know that they can call laboratories directly and expedite this sort of testing.” 

Dr. Rao emphasized that PrEP does not eliminate the need for postexposure prophylaxis (PEP). Still, it eliminates the need for rabies immunoglobulin and decreases the number of vaccine doses required for PEP. “I hope more people will take advantage of the titer checks and potentially save the patient some money,” she concluded.

Dr. Rao and Dr. Hemachudha have disclosed no relevant financial relationships.

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

Each year, there are about 59,000 deaths from rabies globally. Most of these occur outside the United States and are the result of dog bites. Since infection with rabies is almost always fatal, there has been considerable attention given to vaccinating people at high risk before likely exposure and responding immediately to those bitten by a rabid animal.

The Centers for Disease Control and Prevention recently revised its preexposure prophylaxis (PrEP) recommendations for rabies. Under the previous 2008 guidelines, PrEP injections were given on days 0, 7, and 21 and cost more than $1,100. In trying to simplify recommendations and make immunization less expensive, the agency designated five risk levels with different advice based on the level of risk.

The first two groups are those with very high risk of occupational exposures – either working with rabies virus in the laboratory or working with or having contact with bats or performing animal necropsies. They are now advised to get two doses of rabies vaccine on days 0 and 7. The lab workers should have titers checked every 6 months to ensure that they remain adequately protected. And a booster should be given if the titer drops to < 0.5 IU/mL. The second group, with bat exposures, should have titers checked every 2 years.

Risk category 3 is those with long-term (> 3 years) exposure to mammals other than bats that might be rabid. This group would include veterinarians, wildlife biologists, animal control officers, and spelunkers (cavers). Category 3 also includes travelers who may encounter rabid dogs, which is not a risk in the United States. They would get the same initial two doses. The new recommendations for a third dose are based either on a titer drawn 1-3 years later being < 0.5 IU/mL or choosing to give a booster between 3 weeks and 3 years after the second dose.

The same groups are covered in risk group 4, but these are expected to have less than 3 years of potential exposure after PrEP. They would receive two doses on days 0 and 7.

Finally, group 5, at the lowest risk, includes most of the U.S. population. They do not require any PrEP.

Agam Rao, MD, CAPT, U.S. Public Health Service, CDC, told this news organization that the CDC’s Advisory Committee on Immunization Practices (ACIP) has been working on updating the 2008 rabies PrEP recommendations for several years. The committee wanted the new guideline to be “as easily followable as possible but also based on the evidence itself.”

There were two significant problems the committee tried to address. “One was that travelers who book their travel on kind of short notice don’t have enough time to get that third dose, which at the earliest can be given on day 21,” Dr. Rao said.

The second problem is that “a three-dose series [is] just really expensive. And what we found from data that had been published since the last ACIP recommendations is that fewer people than we recommend get vaccinated were getting vaccinated. So hopefully, the two-dose series helps with that.”

The ACIP used an adapted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to determine the certainty of the evidence for immunogenicity. The ACIP also used an evidence to recommendations (EtR) framework. “This incorporates a lot of other factors like the acceptability, usability, equity, all of these other variables that are important to the evidence being translated into recommendations,” Dr. Rao said. A table details their analysis.

Rabies expert Thiravat Hemachudha, MD, professor of neurology at WHO Collaborating Centre for Research and Training on Viral Zoonoses, Chulalongkorn University Hospital, Bangkok, told this news organization via email that “the ACIP relies mostly on serology, whereas the rest of the world cannot afford the test or testing may not be available.”

He added: “The issue of ‘long-term immunogenicity’ after receiving [PrEP is] an anamnestic response. All standard tissue culture rabies vaccines with appropriate dosage and route of delivery, either IM or ID, are considered safe and effective. There are many studies in Asian countries confirming that with only one primary series of PrEP, ID or IM with reduced doses, can produce immunity for as long as 20 years. Therefore, serology check is not necessary in general populations in rabies endemic countries where most of the rabies deaths occur. Investigation of all death cases was performed in Thailand and did not reveal any failure. Cases with PrEP in the past who died did not receive a booster after exposure.”

Dr. Rao offered one additional suggestion to clinicians faced with an urgent need to get a rabies titer: “They really should reach out to the lab (with all the information) before they send the specimen for the titer check ... so that the testing can be facilitated. All of these laboratories have the capacity to do stat and ASAP testing ... Clinicians do not know that they can call laboratories directly and expedite this sort of testing.” 

Dr. Rao emphasized that PrEP does not eliminate the need for postexposure prophylaxis (PEP). Still, it eliminates the need for rabies immunoglobulin and decreases the number of vaccine doses required for PEP. “I hope more people will take advantage of the titer checks and potentially save the patient some money,” she concluded.

Dr. Rao and Dr. Hemachudha have disclosed no relevant financial relationships.

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

Respiratory syncytial virus (RSV) caused more than 100,000 deaths in children under age 5 years globally in 2019, according to an analysis published online in The Lancet.

Researchers, led by You Li, PhD, of Nanjing (China) Medical University, found that nearly half of those (more than 45,000) occurred in children younger than 6 months old.

They estimated that RSV causes 1 in 50 deaths among children under 5 years old, and 1 in 28 deaths in children under 6 months old.

Additionally, RSV is responsible for an estimated 3.6 million hospital admissions globally each year, according to the report.

This analysis is the first to sift RSV disease burden into narrow age brackets, the authors said.

The numbers highlight that almost all of the deaths (97%) were in low- and middle-income countries.
 

Messages for prevention

Tina Hartert, MD, MPH, a professor in the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., who was not part of the study, wrote in an invited commentary that these findings will be important in RSV prevention.

Among the most notable findings, she wrote, is the heavy mortality in the 0- to 6-month age group, which she notes is “the age group targeted by vaccination during pregnancy and birth-dose immunoprophylaxis.”

Dr. Hartert, who coauthored the commentary with Justin R. Ortiz, MD, MS, with the Center for Vaccine Development and Global Health, University of Maryland, Baltimore, told this news organization, “RSV is a respiratory virus that infects nearly every child by the time they are 2-3 years of age, with severe infection and death most common in the youngest infants. Vaccines that prevent the most severe infections in these young infants will likely be one of the best ways to prevent these severe infections and death.”

Though the authors found most deaths occur in low- and middle-income countries, RSV is one of the most common reasons for infant hospitalization in the US and affects 1% to 3% of infants, half of whom are full-term and otherwise healthy, Dr. Hartert said.

It is also one of the most common causes of infant lower respiratory tract infection in young children in the United States, she said, and it causes the most severe disease at the age extremes, with older adults experiencing significant morbidity with RSV.

Dr. Li said in an interview that although the team did not focus on reporting country-specific estimates in this work, their previous work, resulted in estimates of 98,000-155,000 RSV-related hospitalizations in children under 5 years old in the United States in 2019. Between 65,000 and 86,000 were in infants less than 1 year old.

Currently, he said, the only available RSV prophylaxis is palivizumab (Synagis), which is expensive and given only to high-risk infants in high-income countries, including the United States.

“There have been a number of promising RSV prophylactic products including maternal vaccine and monoclonal antibodies that have the potential for targeting the general infant population – not just high-risk infants – in late-phase clinical trials,” he said. “Our estimates of RSV-related disease burden will help anticipate the impact of future RSV immunization programs.”
 

Pandemic changed patterns

This research was completed before the COVID-19 pandemic, and it is not yet known how that could affect RSV disease burden long term.

However, Dr. Hartert said, RSV circulation has been significantly changed during the pandemic, both in intensity and timing, likely because of a combination of COVID and the public health preventive measures.

“As people return to normal activities and the public health measures put in place to stop the spread of COVID are eased, we are likely to see increases in circulation of RSV and return to its circulation during the winter months – typically similar to circulation of flu – from November through March in temperate climates in the northern hemisphere,” she said.

A coauthor of the paper, Harish Nair, PhD, with the Centre for Global Health, Usher Institute, University of Edinburgh, said in a press release that their findings have particular significance as COVID restrictions ease around the globe.

“The majority of the young children born in the last 2 years have never been exposed to RSV (and therefore have no immunity against this virus),” Nair wrote.
 

Most deaths occurring outside hospitals

A challenge in reducing the deaths in those 5 years old and younger is that most (76%) of deaths are happening in the community outside hospitals.

The authors wrote: “For every RSV-associated acute lower respiratory infection in-hospital death, we estimate approximately three more deaths attributable to RSV in the community.”

The percentage dying outside hospitals is even larger (81%) in low- to middle-income countries.

This work built on a previous review by the team that analyzed 317 studies. They updated their search with 113 new eligible studies and unpublished data from 51 papers published between Jan. 1, 2017, and Dec. 31, 2020.

The authors acknowledged some limitations, including variations in study settings and in definitions for acute lower respiratory infection, healthcare access, and eligibility for RSV testing.

The study was funded by EU Innovative Medicines Initiative Respiratory Syncytial Virus Consortium in Europe. Dr. Li reported grants from Wellcome Trust and the World Health Organization outside the submitted work. Dr. Hartert, Dr. Ortiz, and Dr. Nair disclosed no relevant financial relationships.

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

Respiratory syncytial virus (RSV) caused more than 100,000 deaths in children under age 5 years globally in 2019, according to an analysis published online in The Lancet.

Researchers, led by You Li, PhD, of Nanjing (China) Medical University, found that nearly half of those (more than 45,000) occurred in children younger than 6 months old.

They estimated that RSV causes 1 in 50 deaths among children under 5 years old, and 1 in 28 deaths in children under 6 months old.

Additionally, RSV is responsible for an estimated 3.6 million hospital admissions globally each year, according to the report.

This analysis is the first to sift RSV disease burden into narrow age brackets, the authors said.

The numbers highlight that almost all of the deaths (97%) were in low- and middle-income countries.
 

Messages for prevention

Tina Hartert, MD, MPH, a professor in the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., who was not part of the study, wrote in an invited commentary that these findings will be important in RSV prevention.

Among the most notable findings, she wrote, is the heavy mortality in the 0- to 6-month age group, which she notes is “the age group targeted by vaccination during pregnancy and birth-dose immunoprophylaxis.”

Dr. Hartert, who coauthored the commentary with Justin R. Ortiz, MD, MS, with the Center for Vaccine Development and Global Health, University of Maryland, Baltimore, told this news organization, “RSV is a respiratory virus that infects nearly every child by the time they are 2-3 years of age, with severe infection and death most common in the youngest infants. Vaccines that prevent the most severe infections in these young infants will likely be one of the best ways to prevent these severe infections and death.”

Though the authors found most deaths occur in low- and middle-income countries, RSV is one of the most common reasons for infant hospitalization in the US and affects 1% to 3% of infants, half of whom are full-term and otherwise healthy, Dr. Hartert said.

It is also one of the most common causes of infant lower respiratory tract infection in young children in the United States, she said, and it causes the most severe disease at the age extremes, with older adults experiencing significant morbidity with RSV.

Dr. Li said in an interview that although the team did not focus on reporting country-specific estimates in this work, their previous work, resulted in estimates of 98,000-155,000 RSV-related hospitalizations in children under 5 years old in the United States in 2019. Between 65,000 and 86,000 were in infants less than 1 year old.

Currently, he said, the only available RSV prophylaxis is palivizumab (Synagis), which is expensive and given only to high-risk infants in high-income countries, including the United States.

“There have been a number of promising RSV prophylactic products including maternal vaccine and monoclonal antibodies that have the potential for targeting the general infant population – not just high-risk infants – in late-phase clinical trials,” he said. “Our estimates of RSV-related disease burden will help anticipate the impact of future RSV immunization programs.”
 

Pandemic changed patterns

This research was completed before the COVID-19 pandemic, and it is not yet known how that could affect RSV disease burden long term.

However, Dr. Hartert said, RSV circulation has been significantly changed during the pandemic, both in intensity and timing, likely because of a combination of COVID and the public health preventive measures.

“As people return to normal activities and the public health measures put in place to stop the spread of COVID are eased, we are likely to see increases in circulation of RSV and return to its circulation during the winter months – typically similar to circulation of flu – from November through March in temperate climates in the northern hemisphere,” she said.

A coauthor of the paper, Harish Nair, PhD, with the Centre for Global Health, Usher Institute, University of Edinburgh, said in a press release that their findings have particular significance as COVID restrictions ease around the globe.

“The majority of the young children born in the last 2 years have never been exposed to RSV (and therefore have no immunity against this virus),” Nair wrote.
 

Most deaths occurring outside hospitals

A challenge in reducing the deaths in those 5 years old and younger is that most (76%) of deaths are happening in the community outside hospitals.

The authors wrote: “For every RSV-associated acute lower respiratory infection in-hospital death, we estimate approximately three more deaths attributable to RSV in the community.”

The percentage dying outside hospitals is even larger (81%) in low- to middle-income countries.

This work built on a previous review by the team that analyzed 317 studies. They updated their search with 113 new eligible studies and unpublished data from 51 papers published between Jan. 1, 2017, and Dec. 31, 2020.

The authors acknowledged some limitations, including variations in study settings and in definitions for acute lower respiratory infection, healthcare access, and eligibility for RSV testing.

The study was funded by EU Innovative Medicines Initiative Respiratory Syncytial Virus Consortium in Europe. Dr. Li reported grants from Wellcome Trust and the World Health Organization outside the submitted work. Dr. Hartert, Dr. Ortiz, and Dr. Nair disclosed no relevant financial relationships.

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

Respiratory syncytial virus (RSV) caused more than 100,000 deaths in children under age 5 years globally in 2019, according to an analysis published online in The Lancet.

Researchers, led by You Li, PhD, of Nanjing (China) Medical University, found that nearly half of those (more than 45,000) occurred in children younger than 6 months old.

They estimated that RSV causes 1 in 50 deaths among children under 5 years old, and 1 in 28 deaths in children under 6 months old.

Additionally, RSV is responsible for an estimated 3.6 million hospital admissions globally each year, according to the report.

This analysis is the first to sift RSV disease burden into narrow age brackets, the authors said.

The numbers highlight that almost all of the deaths (97%) were in low- and middle-income countries.
 

Messages for prevention

Tina Hartert, MD, MPH, a professor in the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., who was not part of the study, wrote in an invited commentary that these findings will be important in RSV prevention.

Among the most notable findings, she wrote, is the heavy mortality in the 0- to 6-month age group, which she notes is “the age group targeted by vaccination during pregnancy and birth-dose immunoprophylaxis.”

Dr. Hartert, who coauthored the commentary with Justin R. Ortiz, MD, MS, with the Center for Vaccine Development and Global Health, University of Maryland, Baltimore, told this news organization, “RSV is a respiratory virus that infects nearly every child by the time they are 2-3 years of age, with severe infection and death most common in the youngest infants. Vaccines that prevent the most severe infections in these young infants will likely be one of the best ways to prevent these severe infections and death.”

Though the authors found most deaths occur in low- and middle-income countries, RSV is one of the most common reasons for infant hospitalization in the US and affects 1% to 3% of infants, half of whom are full-term and otherwise healthy, Dr. Hartert said.

It is also one of the most common causes of infant lower respiratory tract infection in young children in the United States, she said, and it causes the most severe disease at the age extremes, with older adults experiencing significant morbidity with RSV.

Dr. Li said in an interview that although the team did not focus on reporting country-specific estimates in this work, their previous work, resulted in estimates of 98,000-155,000 RSV-related hospitalizations in children under 5 years old in the United States in 2019. Between 65,000 and 86,000 were in infants less than 1 year old.

Currently, he said, the only available RSV prophylaxis is palivizumab (Synagis), which is expensive and given only to high-risk infants in high-income countries, including the United States.

“There have been a number of promising RSV prophylactic products including maternal vaccine and monoclonal antibodies that have the potential for targeting the general infant population – not just high-risk infants – in late-phase clinical trials,” he said. “Our estimates of RSV-related disease burden will help anticipate the impact of future RSV immunization programs.”
 

Pandemic changed patterns

This research was completed before the COVID-19 pandemic, and it is not yet known how that could affect RSV disease burden long term.

However, Dr. Hartert said, RSV circulation has been significantly changed during the pandemic, both in intensity and timing, likely because of a combination of COVID and the public health preventive measures.

“As people return to normal activities and the public health measures put in place to stop the spread of COVID are eased, we are likely to see increases in circulation of RSV and return to its circulation during the winter months – typically similar to circulation of flu – from November through March in temperate climates in the northern hemisphere,” she said.

A coauthor of the paper, Harish Nair, PhD, with the Centre for Global Health, Usher Institute, University of Edinburgh, said in a press release that their findings have particular significance as COVID restrictions ease around the globe.

“The majority of the young children born in the last 2 years have never been exposed to RSV (and therefore have no immunity against this virus),” Nair wrote.
 

Most deaths occurring outside hospitals

A challenge in reducing the deaths in those 5 years old and younger is that most (76%) of deaths are happening in the community outside hospitals.

The authors wrote: “For every RSV-associated acute lower respiratory infection in-hospital death, we estimate approximately three more deaths attributable to RSV in the community.”

The percentage dying outside hospitals is even larger (81%) in low- to middle-income countries.

This work built on a previous review by the team that analyzed 317 studies. They updated their search with 113 new eligible studies and unpublished data from 51 papers published between Jan. 1, 2017, and Dec. 31, 2020.

The authors acknowledged some limitations, including variations in study settings and in definitions for acute lower respiratory infection, healthcare access, and eligibility for RSV testing.

The study was funded by EU Innovative Medicines Initiative Respiratory Syncytial Virus Consortium in Europe. Dr. Li reported grants from Wellcome Trust and the World Health Organization outside the submitted work. Dr. Hartert, Dr. Ortiz, and Dr. Nair disclosed no relevant financial relationships.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.

The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.

At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.

ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.

They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.

CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.

“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.

Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.

“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”

Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.

Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.

“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.

The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.

Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.

“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”

At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.

COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.

Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.

“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
 

Responding to early data

As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.

The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.

Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
 

CDC seeks help tracking vaccine complications

At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.

“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.

About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.

One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.

The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.

At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.

ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.

They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.

CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.

“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.

Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.

“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”

Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.

Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.

“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.

The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.

Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.

“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”

At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.

COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.

Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.

“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
 

Responding to early data

As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.

The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.

Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
 

CDC seeks help tracking vaccine complications

At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.

“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.

About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.

One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.

The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.

At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.

ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.

They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.

CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.

“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.

Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.

“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”

Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.

Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.

“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.

The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.

Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.

“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”

At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.

COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.

Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.

“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
 

Responding to early data

As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.

The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.

Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
 

CDC seeks help tracking vaccine complications

At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.

“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.

About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.

One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.

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

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

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

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

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

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

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

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

rfranki@mdedge.com

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

rfranki@mdedge.com

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

rfranki@mdedge.com

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.