MDedge Pediatrics

Because the Delta variant of SARS-CoV-2 spreads more easily than the original virus, the proportion of the population that needs to be vaccinated to reach herd immunity could be upward of 80% or more, experts say.

Also, it could be time to consider wearing an N95 mask in public indoor spaces regardless of vaccination status, according to a media briefing on Aug. 3 sponsored by the Infectious Diseases Society of America.

Furthermore, giving booster shots to the fully vaccinated is not the top public health priority now. Instead, third vaccinations should be reserved for more vulnerable populations – and efforts should focus on getting first vaccinations to unvaccinated people in the United States and around the world.

“The problem here is that the Delta variant is ... more transmissible than the original virus. That pushes the overall population herd immunity threshold much higher,” Ricardo Franco, MD, assistant professor of medicine at the University of Alabama at Birmingham, said during the briefing.

“For Delta, those threshold estimates go well over 80% and may be approaching 90%,” he said.

To put that figure in context, the original SARS-CoV-2 virus required an estimated 67% of the population to be vaccinated to achieve herd immunity. Also, measles has one of the highest herd immunity thresholds at 95%, Dr. Franco added.

Herd immunity is the point at which enough people are immunized that the entire population gains protection. And it’s already happening. “Unvaccinated people are actually benefiting from greater herd immunity protection in high-vaccination counties compared to low-vaccination ones,” he said.
 

Maximize mask protection

Unlike early in the COVID-19 pandemic with widespread shortages of personal protective equipment, face masks are now readily available. This includes N95 masks, which offer enhanced protection against SARS-CoV-2, Ezekiel J. Emanuel, MD, PhD, said during the briefing.

Following the July 27 CDC recommendation that most Americans wear masks indoors when in public places, “I do think we need to upgrade our masks,” said Dr. Emanuel, who is Diane v.S. Levy & Robert M. Levy professor at the University of Pennsylvania, Philadelphia.

“It’s not just any mask,” he added. “Good masks make a big difference and are very important.”

Mask protection is about blocking 0.3-mcm particles, “and I think we need to make sure that people have masks that can filter that out,” he said. Although surgical masks are very good, he added, “they’re not quite as good as N95s.” As their name implies, N95s filter out 95% of these particles.

Dr. Emanuel acknowledged that people are tired of COVID-19 and complying with public health measures but urged perseverance. “We’ve sacrificed a lot. We should not throw it away in just a few months because we are tired. We’re all tired, but we do have to do the little bit extra getting vaccinated, wearing masks indoors, and protecting ourselves, our families, and our communities.”
 

Dealing with a disconnect

In response to a reporter’s question about the possibility that the large crowd at the Lollapalooza music festival in Chicago could become a superspreader event, Dr. Emanuel said, “it is worrisome.”

“I would say that, if you’re going to go to a gathering like that, wearing an N95 mask is wise, and not spending too long at any one place is also wise,” he said.

On the plus side, the event was held outdoors with lots of air circulation, Dr. Emanuel said.

However, “this is the kind of thing where we’ve got a sort of disconnect between people’s desire to get back to normal ... and the fact that we’re in the middle of this upsurge.”

Another potential problem is the event brought people together from many different locations, so when they travel home, they could be “potentially seeding lots of other communities.”
 

Boosters for some, for now

Even though not officially recommended, some fully vaccinated Americans are seeking a third or booster vaccination on their own.

Asked for his opinion, Dr. Emanuel said: “We’re probably going to have to be giving boosters to immunocompromised people and people who are susceptible. That’s where we are going to start.”

More research is needed regarding booster shots, he said. “There are very small studies – and the ‘very small’ should be emphasized – given that we’ve given shots to over 160 million people.”

“But it does appear that the boosters increase the antibodies and protection,” he said.

Instead of boosters, it is more important for people who haven’t been vaccinated to get fully vaccinated.

“We need to put our priorities in the right places,” he said.

Emanuel noted that, except for people in rural areas that might have to travel long distances, access to vaccines is no longer an issue. “It’s very hard not to find a vaccine if you want it.”

A remaining hurdle is “battling a major disinformation initiative. I don’t think this is misinformation. I think there’s very clear evidence that it is disinformation – false facts about the vaccines being spread,” Dr. Emanuel said.
 

The breakthrough infection dilemma

Breakthrough cases “remain the vast minority of infections at this time ... that is reassuring,” Dr. Franco said.

Also, tracking symptomatic breakthrough infections remains easier than studying fully vaccinated people who become infected with SARS-CoV-2 but remain symptom free.

“We really don’t have a good handle on the frequency of asymptomatic cases,” Dr. Emanuel said. “If you’re missing breakthrough infections, a lot of them, you may be missing some [virus] evolution that would be very important for us to follow.” This missing information could include the emergence of new variants.

The asymptomatic breakthrough cases are the most worrisome group,” Dr. Emanuel said. “You get infected, you’re feeling fine. Maybe you’ve got a little sneeze or cough, but nothing unusual. And then you’re still able to transmit the Delta variant.”
 

The big picture

The upsurge in cases, hospitalizations, and deaths is a major challenge, Dr. Emanuel said. “We need to address that by getting many more people vaccinated right now with what are very good vaccines.”

“But it also means that we have to stop being U.S. focused alone.” He pointed out that Delta and other variants originated overseas, “so getting the world vaccinated ... has to be a top priority.”

“We are obviously all facing a challenge as we move into the fall,” Dr. Emanuel said. “With schools opening and employers bringing their employees back together, even if these groups are vaccinated, there are going to be major challenges for all of us.”

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

Because the Delta variant of SARS-CoV-2 spreads more easily than the original virus, the proportion of the population that needs to be vaccinated to reach herd immunity could be upward of 80% or more, experts say.

Also, it could be time to consider wearing an N95 mask in public indoor spaces regardless of vaccination status, according to a media briefing on Aug. 3 sponsored by the Infectious Diseases Society of America.

Furthermore, giving booster shots to the fully vaccinated is not the top public health priority now. Instead, third vaccinations should be reserved for more vulnerable populations – and efforts should focus on getting first vaccinations to unvaccinated people in the United States and around the world.

“The problem here is that the Delta variant is ... more transmissible than the original virus. That pushes the overall population herd immunity threshold much higher,” Ricardo Franco, MD, assistant professor of medicine at the University of Alabama at Birmingham, said during the briefing.

“For Delta, those threshold estimates go well over 80% and may be approaching 90%,” he said.

To put that figure in context, the original SARS-CoV-2 virus required an estimated 67% of the population to be vaccinated to achieve herd immunity. Also, measles has one of the highest herd immunity thresholds at 95%, Dr. Franco added.

Herd immunity is the point at which enough people are immunized that the entire population gains protection. And it’s already happening. “Unvaccinated people are actually benefiting from greater herd immunity protection in high-vaccination counties compared to low-vaccination ones,” he said.
 

Maximize mask protection

Unlike early in the COVID-19 pandemic with widespread shortages of personal protective equipment, face masks are now readily available. This includes N95 masks, which offer enhanced protection against SARS-CoV-2, Ezekiel J. Emanuel, MD, PhD, said during the briefing.

Following the July 27 CDC recommendation that most Americans wear masks indoors when in public places, “I do think we need to upgrade our masks,” said Dr. Emanuel, who is Diane v.S. Levy & Robert M. Levy professor at the University of Pennsylvania, Philadelphia.

“It’s not just any mask,” he added. “Good masks make a big difference and are very important.”

Mask protection is about blocking 0.3-mcm particles, “and I think we need to make sure that people have masks that can filter that out,” he said. Although surgical masks are very good, he added, “they’re not quite as good as N95s.” As their name implies, N95s filter out 95% of these particles.

Dr. Emanuel acknowledged that people are tired of COVID-19 and complying with public health measures but urged perseverance. “We’ve sacrificed a lot. We should not throw it away in just a few months because we are tired. We’re all tired, but we do have to do the little bit extra getting vaccinated, wearing masks indoors, and protecting ourselves, our families, and our communities.”
 

Dealing with a disconnect

In response to a reporter’s question about the possibility that the large crowd at the Lollapalooza music festival in Chicago could become a superspreader event, Dr. Emanuel said, “it is worrisome.”

“I would say that, if you’re going to go to a gathering like that, wearing an N95 mask is wise, and not spending too long at any one place is also wise,” he said.

On the plus side, the event was held outdoors with lots of air circulation, Dr. Emanuel said.

However, “this is the kind of thing where we’ve got a sort of disconnect between people’s desire to get back to normal ... and the fact that we’re in the middle of this upsurge.”

Another potential problem is the event brought people together from many different locations, so when they travel home, they could be “potentially seeding lots of other communities.”
 

Boosters for some, for now

Even though not officially recommended, some fully vaccinated Americans are seeking a third or booster vaccination on their own.

Asked for his opinion, Dr. Emanuel said: “We’re probably going to have to be giving boosters to immunocompromised people and people who are susceptible. That’s where we are going to start.”

More research is needed regarding booster shots, he said. “There are very small studies – and the ‘very small’ should be emphasized – given that we’ve given shots to over 160 million people.”

“But it does appear that the boosters increase the antibodies and protection,” he said.

Instead of boosters, it is more important for people who haven’t been vaccinated to get fully vaccinated.

“We need to put our priorities in the right places,” he said.

Emanuel noted that, except for people in rural areas that might have to travel long distances, access to vaccines is no longer an issue. “It’s very hard not to find a vaccine if you want it.”

A remaining hurdle is “battling a major disinformation initiative. I don’t think this is misinformation. I think there’s very clear evidence that it is disinformation – false facts about the vaccines being spread,” Dr. Emanuel said.
 

The breakthrough infection dilemma

Breakthrough cases “remain the vast minority of infections at this time ... that is reassuring,” Dr. Franco said.

Also, tracking symptomatic breakthrough infections remains easier than studying fully vaccinated people who become infected with SARS-CoV-2 but remain symptom free.

“We really don’t have a good handle on the frequency of asymptomatic cases,” Dr. Emanuel said. “If you’re missing breakthrough infections, a lot of them, you may be missing some [virus] evolution that would be very important for us to follow.” This missing information could include the emergence of new variants.

The asymptomatic breakthrough cases are the most worrisome group,” Dr. Emanuel said. “You get infected, you’re feeling fine. Maybe you’ve got a little sneeze or cough, but nothing unusual. And then you’re still able to transmit the Delta variant.”
 

The big picture

The upsurge in cases, hospitalizations, and deaths is a major challenge, Dr. Emanuel said. “We need to address that by getting many more people vaccinated right now with what are very good vaccines.”

“But it also means that we have to stop being U.S. focused alone.” He pointed out that Delta and other variants originated overseas, “so getting the world vaccinated ... has to be a top priority.”

“We are obviously all facing a challenge as we move into the fall,” Dr. Emanuel said. “With schools opening and employers bringing their employees back together, even if these groups are vaccinated, there are going to be major challenges for all of us.”

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

Because the Delta variant of SARS-CoV-2 spreads more easily than the original virus, the proportion of the population that needs to be vaccinated to reach herd immunity could be upward of 80% or more, experts say.

Also, it could be time to consider wearing an N95 mask in public indoor spaces regardless of vaccination status, according to a media briefing on Aug. 3 sponsored by the Infectious Diseases Society of America.

Furthermore, giving booster shots to the fully vaccinated is not the top public health priority now. Instead, third vaccinations should be reserved for more vulnerable populations – and efforts should focus on getting first vaccinations to unvaccinated people in the United States and around the world.

“The problem here is that the Delta variant is ... more transmissible than the original virus. That pushes the overall population herd immunity threshold much higher,” Ricardo Franco, MD, assistant professor of medicine at the University of Alabama at Birmingham, said during the briefing.

“For Delta, those threshold estimates go well over 80% and may be approaching 90%,” he said.

To put that figure in context, the original SARS-CoV-2 virus required an estimated 67% of the population to be vaccinated to achieve herd immunity. Also, measles has one of the highest herd immunity thresholds at 95%, Dr. Franco added.

Herd immunity is the point at which enough people are immunized that the entire population gains protection. And it’s already happening. “Unvaccinated people are actually benefiting from greater herd immunity protection in high-vaccination counties compared to low-vaccination ones,” he said.
 

Maximize mask protection

Unlike early in the COVID-19 pandemic with widespread shortages of personal protective equipment, face masks are now readily available. This includes N95 masks, which offer enhanced protection against SARS-CoV-2, Ezekiel J. Emanuel, MD, PhD, said during the briefing.

Following the July 27 CDC recommendation that most Americans wear masks indoors when in public places, “I do think we need to upgrade our masks,” said Dr. Emanuel, who is Diane v.S. Levy & Robert M. Levy professor at the University of Pennsylvania, Philadelphia.

“It’s not just any mask,” he added. “Good masks make a big difference and are very important.”

Mask protection is about blocking 0.3-mcm particles, “and I think we need to make sure that people have masks that can filter that out,” he said. Although surgical masks are very good, he added, “they’re not quite as good as N95s.” As their name implies, N95s filter out 95% of these particles.

Dr. Emanuel acknowledged that people are tired of COVID-19 and complying with public health measures but urged perseverance. “We’ve sacrificed a lot. We should not throw it away in just a few months because we are tired. We’re all tired, but we do have to do the little bit extra getting vaccinated, wearing masks indoors, and protecting ourselves, our families, and our communities.”
 

Dealing with a disconnect

In response to a reporter’s question about the possibility that the large crowd at the Lollapalooza music festival in Chicago could become a superspreader event, Dr. Emanuel said, “it is worrisome.”

“I would say that, if you’re going to go to a gathering like that, wearing an N95 mask is wise, and not spending too long at any one place is also wise,” he said.

On the plus side, the event was held outdoors with lots of air circulation, Dr. Emanuel said.

However, “this is the kind of thing where we’ve got a sort of disconnect between people’s desire to get back to normal ... and the fact that we’re in the middle of this upsurge.”

Another potential problem is the event brought people together from many different locations, so when they travel home, they could be “potentially seeding lots of other communities.”
 

Boosters for some, for now

Even though not officially recommended, some fully vaccinated Americans are seeking a third or booster vaccination on their own.

Asked for his opinion, Dr. Emanuel said: “We’re probably going to have to be giving boosters to immunocompromised people and people who are susceptible. That’s where we are going to start.”

More research is needed regarding booster shots, he said. “There are very small studies – and the ‘very small’ should be emphasized – given that we’ve given shots to over 160 million people.”

“But it does appear that the boosters increase the antibodies and protection,” he said.

Instead of boosters, it is more important for people who haven’t been vaccinated to get fully vaccinated.

“We need to put our priorities in the right places,” he said.

Emanuel noted that, except for people in rural areas that might have to travel long distances, access to vaccines is no longer an issue. “It’s very hard not to find a vaccine if you want it.”

A remaining hurdle is “battling a major disinformation initiative. I don’t think this is misinformation. I think there’s very clear evidence that it is disinformation – false facts about the vaccines being spread,” Dr. Emanuel said.
 

The breakthrough infection dilemma

Breakthrough cases “remain the vast minority of infections at this time ... that is reassuring,” Dr. Franco said.

Also, tracking symptomatic breakthrough infections remains easier than studying fully vaccinated people who become infected with SARS-CoV-2 but remain symptom free.

“We really don’t have a good handle on the frequency of asymptomatic cases,” Dr. Emanuel said. “If you’re missing breakthrough infections, a lot of them, you may be missing some [virus] evolution that would be very important for us to follow.” This missing information could include the emergence of new variants.

The asymptomatic breakthrough cases are the most worrisome group,” Dr. Emanuel said. “You get infected, you’re feeling fine. Maybe you’ve got a little sneeze or cough, but nothing unusual. And then you’re still able to transmit the Delta variant.”
 

The big picture

The upsurge in cases, hospitalizations, and deaths is a major challenge, Dr. Emanuel said. “We need to address that by getting many more people vaccinated right now with what are very good vaccines.”

“But it also means that we have to stop being U.S. focused alone.” He pointed out that Delta and other variants originated overseas, “so getting the world vaccinated ... has to be a top priority.”

“We are obviously all facing a challenge as we move into the fall,” Dr. Emanuel said. “With schools opening and employers bringing their employees back together, even if these groups are vaccinated, there are going to be major challenges for all of us.”

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

New COVID-19 cases in children soared by almost 86% over the course of just 1 week, while the number of 12- to 17-year-old children who have received at least one dose of vaccine rose by 5.4%, according to two separate sources.

There were 71,726 new cases reported during the week of July 23-29, compared with 38,654 the previous week, an increase of 85.6%. Meanwhile, the increase over the past 2 weeks – from 23,551 new cases for July 16-22 to almost 72,000 – works out to almost 205%, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children represented 19.0% of the cases reported during the week of July 23-29, and they have made up 14.3% of all cases since the pandemic began, with the total number of cases in children now approaching 4.2 million, the AAP and CHA said in their weekly COVID report. About 22% of the U.S. population is under the age of 18 years.

As of Aug. 2, just over 9.8 million children aged 12-17 years had received at least one dose of the COVID vaccine, which was up by about 500,000, or 5.4%, from a week earlier, based on data from the Centers for Disease Control and Prevention.

Children aged 16-17 have reached a notable milestone on the journey that started with vaccine approval in December: 50.2% have gotten at least one dose and 40.3% are fully vaccinated. Among children aged 12-15 years, the proportion with at least one dose of vaccine is up to 39.5%, compared with 37.1% the previous week, while 29.0% are fully vaccinated (27.8% the week before), the CDC said on its COVID Data Tracker.

The national rates for child vaccination, however, tend to hide the disparities between states. There is a gap between Mississippi (lowest), where just 17% of children aged 12-17 years have gotten at least one dose, and Vermont (highest), which is up to 69%. Vermont also has the highest rate of vaccine completion (60%), while Alabama and Mississippi have the lowest (10%), according to a solo report from the AAP.

[email protected]

New COVID-19 cases in children soared by almost 86% over the course of just 1 week, while the number of 12- to 17-year-old children who have received at least one dose of vaccine rose by 5.4%, according to two separate sources.

There were 71,726 new cases reported during the week of July 23-29, compared with 38,654 the previous week, an increase of 85.6%. Meanwhile, the increase over the past 2 weeks – from 23,551 new cases for July 16-22 to almost 72,000 – works out to almost 205%, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children represented 19.0% of the cases reported during the week of July 23-29, and they have made up 14.3% of all cases since the pandemic began, with the total number of cases in children now approaching 4.2 million, the AAP and CHA said in their weekly COVID report. About 22% of the U.S. population is under the age of 18 years.

As of Aug. 2, just over 9.8 million children aged 12-17 years had received at least one dose of the COVID vaccine, which was up by about 500,000, or 5.4%, from a week earlier, based on data from the Centers for Disease Control and Prevention.

Children aged 16-17 have reached a notable milestone on the journey that started with vaccine approval in December: 50.2% have gotten at least one dose and 40.3% are fully vaccinated. Among children aged 12-15 years, the proportion with at least one dose of vaccine is up to 39.5%, compared with 37.1% the previous week, while 29.0% are fully vaccinated (27.8% the week before), the CDC said on its COVID Data Tracker.

The national rates for child vaccination, however, tend to hide the disparities between states. There is a gap between Mississippi (lowest), where just 17% of children aged 12-17 years have gotten at least one dose, and Vermont (highest), which is up to 69%. Vermont also has the highest rate of vaccine completion (60%), while Alabama and Mississippi have the lowest (10%), according to a solo report from the AAP.

[email protected]

New COVID-19 cases in children soared by almost 86% over the course of just 1 week, while the number of 12- to 17-year-old children who have received at least one dose of vaccine rose by 5.4%, according to two separate sources.

There were 71,726 new cases reported during the week of July 23-29, compared with 38,654 the previous week, an increase of 85.6%. Meanwhile, the increase over the past 2 weeks – from 23,551 new cases for July 16-22 to almost 72,000 – works out to almost 205%, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children represented 19.0% of the cases reported during the week of July 23-29, and they have made up 14.3% of all cases since the pandemic began, with the total number of cases in children now approaching 4.2 million, the AAP and CHA said in their weekly COVID report. About 22% of the U.S. population is under the age of 18 years.

As of Aug. 2, just over 9.8 million children aged 12-17 years had received at least one dose of the COVID vaccine, which was up by about 500,000, or 5.4%, from a week earlier, based on data from the Centers for Disease Control and Prevention.

Children aged 16-17 have reached a notable milestone on the journey that started with vaccine approval in December: 50.2% have gotten at least one dose and 40.3% are fully vaccinated. Among children aged 12-15 years, the proportion with at least one dose of vaccine is up to 39.5%, compared with 37.1% the previous week, while 29.0% are fully vaccinated (27.8% the week before), the CDC said on its COVID Data Tracker.

The national rates for child vaccination, however, tend to hide the disparities between states. There is a gap between Mississippi (lowest), where just 17% of children aged 12-17 years have gotten at least one dose, and Vermont (highest), which is up to 69%. Vermont also has the highest rate of vaccine completion (60%), while Alabama and Mississippi have the lowest (10%), according to a solo report from the AAP.

[email protected]

Like many colleagues, I have been working to change the minds and behaviors of acquaintances and patients who are opting to forgo a COVID vaccine. The large numbers of these unvaccinated Americans, combined with the surging Delta coronavirus variant, are endangering the health of us all.

When I spoke with the 22-year-old daughter of a family friend about what was holding her back, she told me that she would “never” get vaccinated. I shared my vaccination experience and told her that, except for a sore arm both times for a day, I felt no side effects. Likewise, I said, all of my adult family members are vaccinated, and everyone is fine. She was neither moved nor convinced.

Finally, I asked her whether she attended school (knowing that she was a college graduate), and she said “yes.” So I told her that all 50 states require children attending public schools to be vaccinated for diseases such as diphtheria, tetanus, polio, and the chickenpox – with certain religious, philosophical, and medical exemptions. Her response was simple: “I didn’t know that. Anyway, my parents were in charge.” Suddenly, her thinking shifted. “You’re right,” she said. She got a COVID shot the next day. Success for me.

When I asked another acquaintance whether he’d been vaccinated, he said he’d heard people were getting very sick from the vaccine – and was going to wait. Another gentleman I spoke with said that, at age 45, he was healthy. Besides, he added, he “doesn’t get sick.” When I asked another acquaintance about her vaccination status, her retort was that this was none of my business. So far, I’m batting about .300.

But as a physician, I believe that we – and other health care providers – must continue to encourage the people in our lives to care for themselves and others by getting vaccinated. One concrete step advised by the Centers for Disease Control and Prevention is to help people make an appointment for a shot. Some sites no longer require appointments, and New York City, for example, offers in-home vaccinations to all NYC residents.

Also, NYC Mayor Bill de Blasio announced Aug. 3 the “Key to NYC Pass,” which he called a “first-in-the-nation approach” to vaccination. Under this new policy, vaccine-eligible people aged 12 and older in New York City will need to prove with a vaccination card, an app, or an Excelsior Pass that they have received at least one dose of vaccine before participating in indoor venues such as restaurants, bars, gyms, and movie theaters within the city. Mayor de Blasio said the new initiative, which is still being finalized, will be phased in starting the week of Aug. 16. I see this as a major public health measure that will keep people healthy – and get them vaccinated.

The medical community should support this move by the city of New York and encourage people to follow CDC guidance on wearing face coverings in public settings, especially schools. New research shows that physicians continue to be among the most trusted sources of vaccine-related information.

Another strategy we might use is to point to the longtime practices of surgeons. We could ask: Why do surgeons wear face masks in the operating room? For years, these coverings have been used to protect patients from the nasal and oral bacteria generated by operating room staff. Likewise, we can tell those who remain on the fence that, by wearing face masks, we are protecting others from all variants, but specifically from Delta – which the CDC now says can be transmitted by people who are fully vaccinated.

Why did the CDC lift face mask guidance for fully vaccinated people in indoor spaces in May? It was clear to me and other colleagues back then that this was not a good idea. Despite that guidance, I continued to wear a mask in public places and advised anyone who would listen to do the same.

The development of vaccines in the 20th and 21st centuries has saved millions of lives. The World Health Organization reports that 4 million to 5 million lives a year are saved by immunizations. In addition, research shows that, before the emergence of SARS-CoV-2, vaccinations led to the eradication of smallpox and polio, and a 74% drop in measles-related deaths between 2004 and 2014.
 

Protecting the most vulnerable

With COVID cases surging, particularly in parts of the South and Midwest, I am concerned about children under age 12 who do not yet qualify for a vaccine. Certainly, unvaccinated parents could spread the virus to their young children, and unvaccinated children could transmit the illness to immediate and extended family. Now that the CDC has said that there is a risk of SARS-CoV-2 breakthrough infection among fully vaccinated people in areas with high community transmission, should we worry about unvaccinated young children with vaccinated parents? I recently spoke with James C. Fagin, MD, a board-certified pediatrician and immunologist, to get his views on this issue.

Dr. Fagin, who is retired, said he is in complete agreement with the Food and Drug Administration when it comes to approving medications for children. However, given the seriousness of the pandemic and the need to get our children back to in-person learning, he would like to see the approval process safely expedited. Large numbers of unvaccinated people increase the pool for the Delta variant and could increase the likelihood of a new variant that is more resistant to the vaccines, said Dr. Fagin, former chief of academic pediatrics at North Shore University Hospital and a former faculty member in the allergy/immunology division of Cohen Children’s Medical Center, both in New York.

Meanwhile, I agree with the American Academy of Pediatrics’ recommendations that children, teachers, and school staff and other adults in school settings should wear masks regardless of vaccination status. Kids adjust well to masks – as my grandchildren and their friends have.

The bottom line is that we need to get as many people as possible vaccinated as soon as possible, and while doing so, we must continue to wear face coverings in public spaces. As clinicians, we have a special responsibility to do all that we can to change minds – and behaviors.

Dr. London is a practicing psychiatrist who has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

Like many colleagues, I have been working to change the minds and behaviors of acquaintances and patients who are opting to forgo a COVID vaccine. The large numbers of these unvaccinated Americans, combined with the surging Delta coronavirus variant, are endangering the health of us all.

When I spoke with the 22-year-old daughter of a family friend about what was holding her back, she told me that she would “never” get vaccinated. I shared my vaccination experience and told her that, except for a sore arm both times for a day, I felt no side effects. Likewise, I said, all of my adult family members are vaccinated, and everyone is fine. She was neither moved nor convinced.

Finally, I asked her whether she attended school (knowing that she was a college graduate), and she said “yes.” So I told her that all 50 states require children attending public schools to be vaccinated for diseases such as diphtheria, tetanus, polio, and the chickenpox – with certain religious, philosophical, and medical exemptions. Her response was simple: “I didn’t know that. Anyway, my parents were in charge.” Suddenly, her thinking shifted. “You’re right,” she said. She got a COVID shot the next day. Success for me.

When I asked another acquaintance whether he’d been vaccinated, he said he’d heard people were getting very sick from the vaccine – and was going to wait. Another gentleman I spoke with said that, at age 45, he was healthy. Besides, he added, he “doesn’t get sick.” When I asked another acquaintance about her vaccination status, her retort was that this was none of my business. So far, I’m batting about .300.

But as a physician, I believe that we – and other health care providers – must continue to encourage the people in our lives to care for themselves and others by getting vaccinated. One concrete step advised by the Centers for Disease Control and Prevention is to help people make an appointment for a shot. Some sites no longer require appointments, and New York City, for example, offers in-home vaccinations to all NYC residents.

Also, NYC Mayor Bill de Blasio announced Aug. 3 the “Key to NYC Pass,” which he called a “first-in-the-nation approach” to vaccination. Under this new policy, vaccine-eligible people aged 12 and older in New York City will need to prove with a vaccination card, an app, or an Excelsior Pass that they have received at least one dose of vaccine before participating in indoor venues such as restaurants, bars, gyms, and movie theaters within the city. Mayor de Blasio said the new initiative, which is still being finalized, will be phased in starting the week of Aug. 16. I see this as a major public health measure that will keep people healthy – and get them vaccinated.

The medical community should support this move by the city of New York and encourage people to follow CDC guidance on wearing face coverings in public settings, especially schools. New research shows that physicians continue to be among the most trusted sources of vaccine-related information.

Another strategy we might use is to point to the longtime practices of surgeons. We could ask: Why do surgeons wear face masks in the operating room? For years, these coverings have been used to protect patients from the nasal and oral bacteria generated by operating room staff. Likewise, we can tell those who remain on the fence that, by wearing face masks, we are protecting others from all variants, but specifically from Delta – which the CDC now says can be transmitted by people who are fully vaccinated.

Why did the CDC lift face mask guidance for fully vaccinated people in indoor spaces in May? It was clear to me and other colleagues back then that this was not a good idea. Despite that guidance, I continued to wear a mask in public places and advised anyone who would listen to do the same.

The development of vaccines in the 20th and 21st centuries has saved millions of lives. The World Health Organization reports that 4 million to 5 million lives a year are saved by immunizations. In addition, research shows that, before the emergence of SARS-CoV-2, vaccinations led to the eradication of smallpox and polio, and a 74% drop in measles-related deaths between 2004 and 2014.
 

Protecting the most vulnerable

With COVID cases surging, particularly in parts of the South and Midwest, I am concerned about children under age 12 who do not yet qualify for a vaccine. Certainly, unvaccinated parents could spread the virus to their young children, and unvaccinated children could transmit the illness to immediate and extended family. Now that the CDC has said that there is a risk of SARS-CoV-2 breakthrough infection among fully vaccinated people in areas with high community transmission, should we worry about unvaccinated young children with vaccinated parents? I recently spoke with James C. Fagin, MD, a board-certified pediatrician and immunologist, to get his views on this issue.

Dr. Fagin, who is retired, said he is in complete agreement with the Food and Drug Administration when it comes to approving medications for children. However, given the seriousness of the pandemic and the need to get our children back to in-person learning, he would like to see the approval process safely expedited. Large numbers of unvaccinated people increase the pool for the Delta variant and could increase the likelihood of a new variant that is more resistant to the vaccines, said Dr. Fagin, former chief of academic pediatrics at North Shore University Hospital and a former faculty member in the allergy/immunology division of Cohen Children’s Medical Center, both in New York.

Meanwhile, I agree with the American Academy of Pediatrics’ recommendations that children, teachers, and school staff and other adults in school settings should wear masks regardless of vaccination status. Kids adjust well to masks – as my grandchildren and their friends have.

The bottom line is that we need to get as many people as possible vaccinated as soon as possible, and while doing so, we must continue to wear face coverings in public spaces. As clinicians, we have a special responsibility to do all that we can to change minds – and behaviors.

Dr. London is a practicing psychiatrist who has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

Like many colleagues, I have been working to change the minds and behaviors of acquaintances and patients who are opting to forgo a COVID vaccine. The large numbers of these unvaccinated Americans, combined with the surging Delta coronavirus variant, are endangering the health of us all.

When I spoke with the 22-year-old daughter of a family friend about what was holding her back, she told me that she would “never” get vaccinated. I shared my vaccination experience and told her that, except for a sore arm both times for a day, I felt no side effects. Likewise, I said, all of my adult family members are vaccinated, and everyone is fine. She was neither moved nor convinced.

Finally, I asked her whether she attended school (knowing that she was a college graduate), and she said “yes.” So I told her that all 50 states require children attending public schools to be vaccinated for diseases such as diphtheria, tetanus, polio, and the chickenpox – with certain religious, philosophical, and medical exemptions. Her response was simple: “I didn’t know that. Anyway, my parents were in charge.” Suddenly, her thinking shifted. “You’re right,” she said. She got a COVID shot the next day. Success for me.

When I asked another acquaintance whether he’d been vaccinated, he said he’d heard people were getting very sick from the vaccine – and was going to wait. Another gentleman I spoke with said that, at age 45, he was healthy. Besides, he added, he “doesn’t get sick.” When I asked another acquaintance about her vaccination status, her retort was that this was none of my business. So far, I’m batting about .300.

But as a physician, I believe that we – and other health care providers – must continue to encourage the people in our lives to care for themselves and others by getting vaccinated. One concrete step advised by the Centers for Disease Control and Prevention is to help people make an appointment for a shot. Some sites no longer require appointments, and New York City, for example, offers in-home vaccinations to all NYC residents.

Also, NYC Mayor Bill de Blasio announced Aug. 3 the “Key to NYC Pass,” which he called a “first-in-the-nation approach” to vaccination. Under this new policy, vaccine-eligible people aged 12 and older in New York City will need to prove with a vaccination card, an app, or an Excelsior Pass that they have received at least one dose of vaccine before participating in indoor venues such as restaurants, bars, gyms, and movie theaters within the city. Mayor de Blasio said the new initiative, which is still being finalized, will be phased in starting the week of Aug. 16. I see this as a major public health measure that will keep people healthy – and get them vaccinated.

The medical community should support this move by the city of New York and encourage people to follow CDC guidance on wearing face coverings in public settings, especially schools. New research shows that physicians continue to be among the most trusted sources of vaccine-related information.

Another strategy we might use is to point to the longtime practices of surgeons. We could ask: Why do surgeons wear face masks in the operating room? For years, these coverings have been used to protect patients from the nasal and oral bacteria generated by operating room staff. Likewise, we can tell those who remain on the fence that, by wearing face masks, we are protecting others from all variants, but specifically from Delta – which the CDC now says can be transmitted by people who are fully vaccinated.

Why did the CDC lift face mask guidance for fully vaccinated people in indoor spaces in May? It was clear to me and other colleagues back then that this was not a good idea. Despite that guidance, I continued to wear a mask in public places and advised anyone who would listen to do the same.

The development of vaccines in the 20th and 21st centuries has saved millions of lives. The World Health Organization reports that 4 million to 5 million lives a year are saved by immunizations. In addition, research shows that, before the emergence of SARS-CoV-2, vaccinations led to the eradication of smallpox and polio, and a 74% drop in measles-related deaths between 2004 and 2014.
 

Protecting the most vulnerable

With COVID cases surging, particularly in parts of the South and Midwest, I am concerned about children under age 12 who do not yet qualify for a vaccine. Certainly, unvaccinated parents could spread the virus to their young children, and unvaccinated children could transmit the illness to immediate and extended family. Now that the CDC has said that there is a risk of SARS-CoV-2 breakthrough infection among fully vaccinated people in areas with high community transmission, should we worry about unvaccinated young children with vaccinated parents? I recently spoke with James C. Fagin, MD, a board-certified pediatrician and immunologist, to get his views on this issue.

Dr. Fagin, who is retired, said he is in complete agreement with the Food and Drug Administration when it comes to approving medications for children. However, given the seriousness of the pandemic and the need to get our children back to in-person learning, he would like to see the approval process safely expedited. Large numbers of unvaccinated people increase the pool for the Delta variant and could increase the likelihood of a new variant that is more resistant to the vaccines, said Dr. Fagin, former chief of academic pediatrics at North Shore University Hospital and a former faculty member in the allergy/immunology division of Cohen Children’s Medical Center, both in New York.

Meanwhile, I agree with the American Academy of Pediatrics’ recommendations that children, teachers, and school staff and other adults in school settings should wear masks regardless of vaccination status. Kids adjust well to masks – as my grandchildren and their friends have.

The bottom line is that we need to get as many people as possible vaccinated as soon as possible, and while doing so, we must continue to wear face coverings in public spaces. As clinicians, we have a special responsibility to do all that we can to change minds – and behaviors.

Dr. London is a practicing psychiatrist who has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

Internal Centers for Disease Control and Prevention documents support the high transmission rate of the Delta variant and put the risk in easier to understand terms.

In addition, the agency released a new study that shows that breakthrough infections in the vaccinated make people about as contagious as those who are unvaccinated. The new report, published July 30 in Morbidity and Mortality Weekly Report (MMWR), also reveals that the Delta variant likely causes more severe COVID-19 illness.

Given these recent findings, the internal CDC slide show advises that the agency  should “acknowledge the war has changed.”
 

A ‘pivotal discovery’

CDC Director Rochelle Walensky, MD, MPH, said in a statement that the MMWR report demonstrates “that [D]elta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people.

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with [D]elta can transmit the virus,” she added. “This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation.”

The investigators analyzed 469 COVID-19 cases reported in Massachusetts residents July 3 through 17, 2021. The infections were associated with an outbreak following multiple events and large gatherings in Provincetown in that state’s easternmost Barnstable County, also known as Cape Cod.

Notably, 346 infections, or 74%, of the cases occurred in fully vaccinated individuals. This group had a median age of 42, and 87% were male. Also, 79% of the breakthrough infections were symptomatic.

Researchers also identified the Delta variant in 90% of 133 specimens collected for analysis. Furthermore, viral loads were about the same between samples taken from people who were fully vaccinated and those who were not.

Four of the five people hospitalized were fully vaccinated. No deaths were reported. 

The publication of these results was highly anticipated following the CDC’s updated mask recommendations on July 27.

Outside the scope of the MMWR report is the total number of cases associated with the outbreak, including visitors from outside Massachusetts, which now approach 900 infections, NBC Boston reported.
 

‘Very sobering’ data

“The new information from the CDC around the [D]elta variant is very sobering,” David Hirschwerk, MD, infectious disease specialist at Northwell Health in New Hyde Park, N.Y., said in an interview.

“The CDC is trying to convey and present this uncertain situation clearly to the public based on new, accumulated data,” he said. For example, given the evidence for higher contagiousness of the Delta variant, Dr. Hirschwerk added, “there will be situations where vaccinated people get infected, because the amount of the virus overwhelms the immune protection.

“What is new that is concerning is that people who are vaccinated still have the potential to transmit the virus to the same degree,” he said.

The MMWR study “helps us better understand the question related to whether or not a person who has completed a COVID-19 series can spread the infection,” agreed Michelle Barron, MD, a professor in the division of infectious disease at the University of Colorado, Aurora.

“The message is that, because the [D]elta variant is much more contagious than the original strain, unvaccinated persons need to get vaccinated because it is nearly impossible to avoid the virus indefinitely,” Michael Lin, MD, MPH, infectious diseases specialist and epidemiologist at Rush University Medical Center, Chicago, said when asked to comment.

The new data highlight “that vaccinated persons, if they become sick, should still seek COVID-19 testing and should still isolate, as they are likely contagious,” Dr. Lin added.
 

More contagious than other infections

The internal CDC slide presentation also puts the new transmission risk in simple terms. Saying that the Delta variant is about as contagious as chicken pox, for example, immediately brings back vivid memories for some of staying indoors and away from friends during childhood or teenage outbreaks.

“A lot of people will remember getting chicken pox and then having their siblings get it shortly thereafter,” Dr. Barron said. “The only key thing to note is that this does not mean that the COVID-19 [D]elta variant mechanism of spread is the same as chicken pox and Ebola. The primary means of spread of COVID-19, even the Delta variant, is via droplets.”

This also means each person infected with the Delta variant could infect an average of eight or nine others.

In contrast, the original strain of the SARS-CoV-2 virus was about as infectious as the common cold. In other words, someone was likely to infect about two other people on average.

In addition to the cold, the CDC notes that the Delta variant is now more contagious than Ebola, the seasonal flu, or small pox.

These Delta variant comparisons are one tangible way of explaining why the CDC on July 27 recommended a return to masking in schools and other indoor spaces for people – vaccinated and unvaccinated – in about 70% of the counties across the United States.

In comparing the Delta variant with other infections, “I think the CDC is trying to help people understand a little bit better the situation we now face since the information is so new. We are in a very different position now than just a few weeks ago, and it is hard for people to accept this,” Dr. Hirschwerk said.

The Delta variant is so different that the CDC considers it almost acting like a new virus altogether.

The CDC’s internal documents were first released by The Washington Post on July 29. The slides cite communication challenges for the agency to continue promoting vaccination while also acknowledging that breakthrough cases are occurring and therefore the fully vaccinated, in some instances, are likely infecting others.

Moving back to science talk, the CDC used the recent outbreak in Barnstable County as an example. The cycle threshold, or Ct values, a measure of viral load, were about the same between 80 vaccinated people linked to the outbreak who had a mean Ct value of 21.9, compared with 65 other unvaccinated people with a Ct of 21.5.

Many experts are quick to note that vaccination remains essential, in part because a vaccinated person also walks around with a much lower risk for severe outcomes, hospitalization, and death. In the internal slide show, the CDC points out that vaccination reduces the risk for infection threefold.

“Even with this high amount of virus, [the Delta variant] did not necessarily make the vaccinated individuals as sick,” Dr. Barron said.

In her statement, Dr. Walensky credited collaboration with the Commonwealth of Massachusetts Department of Public Health and the CDC for the new data. She also thanked the residents of Barnstable County for participating in interviews done by contact tracers and their willingness to get tested and adhere to safety protocols after learning of their exposure.
 

Next moves by CDC?

The agency notes that next steps include consideration of prevention measures such as vaccine mandates for healthcare professionals to protect vulnerable populations, universal masking for source control and prevention, and reconsidering other community mitigation strategies.

Asked if this potential policy is appropriate and feasible, Dr. Lin said, “Yes, I believe that every person working in health care should be vaccinated for COVID-19, and it is feasible.”

Dr. Barron agreed as well. “We as health care providers choose to work in health care, and we should be doing everything feasible to ensure that we are protecting our patients and keeping our coworkers safe.”

“Whether you are a health care professional or not, I would urge everyone to get the COVID-19 vaccine, especially as cases across the country continue to rise,” Dr. Hirschwerk said. “Unequivocally vaccines protect you from the virus.”

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

Internal Centers for Disease Control and Prevention documents support the high transmission rate of the Delta variant and put the risk in easier to understand terms.

In addition, the agency released a new study that shows that breakthrough infections in the vaccinated make people about as contagious as those who are unvaccinated. The new report, published July 30 in Morbidity and Mortality Weekly Report (MMWR), also reveals that the Delta variant likely causes more severe COVID-19 illness.

Given these recent findings, the internal CDC slide show advises that the agency  should “acknowledge the war has changed.”
 

A ‘pivotal discovery’

CDC Director Rochelle Walensky, MD, MPH, said in a statement that the MMWR report demonstrates “that [D]elta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people.

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with [D]elta can transmit the virus,” she added. “This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation.”

The investigators analyzed 469 COVID-19 cases reported in Massachusetts residents July 3 through 17, 2021. The infections were associated with an outbreak following multiple events and large gatherings in Provincetown in that state’s easternmost Barnstable County, also known as Cape Cod.

Notably, 346 infections, or 74%, of the cases occurred in fully vaccinated individuals. This group had a median age of 42, and 87% were male. Also, 79% of the breakthrough infections were symptomatic.

Researchers also identified the Delta variant in 90% of 133 specimens collected for analysis. Furthermore, viral loads were about the same between samples taken from people who were fully vaccinated and those who were not.

Four of the five people hospitalized were fully vaccinated. No deaths were reported. 

The publication of these results was highly anticipated following the CDC’s updated mask recommendations on July 27.

Outside the scope of the MMWR report is the total number of cases associated with the outbreak, including visitors from outside Massachusetts, which now approach 900 infections, NBC Boston reported.
 

‘Very sobering’ data

“The new information from the CDC around the [D]elta variant is very sobering,” David Hirschwerk, MD, infectious disease specialist at Northwell Health in New Hyde Park, N.Y., said in an interview.

“The CDC is trying to convey and present this uncertain situation clearly to the public based on new, accumulated data,” he said. For example, given the evidence for higher contagiousness of the Delta variant, Dr. Hirschwerk added, “there will be situations where vaccinated people get infected, because the amount of the virus overwhelms the immune protection.

“What is new that is concerning is that people who are vaccinated still have the potential to transmit the virus to the same degree,” he said.

The MMWR study “helps us better understand the question related to whether or not a person who has completed a COVID-19 series can spread the infection,” agreed Michelle Barron, MD, a professor in the division of infectious disease at the University of Colorado, Aurora.

“The message is that, because the [D]elta variant is much more contagious than the original strain, unvaccinated persons need to get vaccinated because it is nearly impossible to avoid the virus indefinitely,” Michael Lin, MD, MPH, infectious diseases specialist and epidemiologist at Rush University Medical Center, Chicago, said when asked to comment.

The new data highlight “that vaccinated persons, if they become sick, should still seek COVID-19 testing and should still isolate, as they are likely contagious,” Dr. Lin added.
 

More contagious than other infections

The internal CDC slide presentation also puts the new transmission risk in simple terms. Saying that the Delta variant is about as contagious as chicken pox, for example, immediately brings back vivid memories for some of staying indoors and away from friends during childhood or teenage outbreaks.

“A lot of people will remember getting chicken pox and then having their siblings get it shortly thereafter,” Dr. Barron said. “The only key thing to note is that this does not mean that the COVID-19 [D]elta variant mechanism of spread is the same as chicken pox and Ebola. The primary means of spread of COVID-19, even the Delta variant, is via droplets.”

This also means each person infected with the Delta variant could infect an average of eight or nine others.

In contrast, the original strain of the SARS-CoV-2 virus was about as infectious as the common cold. In other words, someone was likely to infect about two other people on average.

In addition to the cold, the CDC notes that the Delta variant is now more contagious than Ebola, the seasonal flu, or small pox.

These Delta variant comparisons are one tangible way of explaining why the CDC on July 27 recommended a return to masking in schools and other indoor spaces for people – vaccinated and unvaccinated – in about 70% of the counties across the United States.

In comparing the Delta variant with other infections, “I think the CDC is trying to help people understand a little bit better the situation we now face since the information is so new. We are in a very different position now than just a few weeks ago, and it is hard for people to accept this,” Dr. Hirschwerk said.

The Delta variant is so different that the CDC considers it almost acting like a new virus altogether.

The CDC’s internal documents were first released by The Washington Post on July 29. The slides cite communication challenges for the agency to continue promoting vaccination while also acknowledging that breakthrough cases are occurring and therefore the fully vaccinated, in some instances, are likely infecting others.

Moving back to science talk, the CDC used the recent outbreak in Barnstable County as an example. The cycle threshold, or Ct values, a measure of viral load, were about the same between 80 vaccinated people linked to the outbreak who had a mean Ct value of 21.9, compared with 65 other unvaccinated people with a Ct of 21.5.

Many experts are quick to note that vaccination remains essential, in part because a vaccinated person also walks around with a much lower risk for severe outcomes, hospitalization, and death. In the internal slide show, the CDC points out that vaccination reduces the risk for infection threefold.

“Even with this high amount of virus, [the Delta variant] did not necessarily make the vaccinated individuals as sick,” Dr. Barron said.

In her statement, Dr. Walensky credited collaboration with the Commonwealth of Massachusetts Department of Public Health and the CDC for the new data. She also thanked the residents of Barnstable County for participating in interviews done by contact tracers and their willingness to get tested and adhere to safety protocols after learning of their exposure.
 

Next moves by CDC?

The agency notes that next steps include consideration of prevention measures such as vaccine mandates for healthcare professionals to protect vulnerable populations, universal masking for source control and prevention, and reconsidering other community mitigation strategies.

Asked if this potential policy is appropriate and feasible, Dr. Lin said, “Yes, I believe that every person working in health care should be vaccinated for COVID-19, and it is feasible.”

Dr. Barron agreed as well. “We as health care providers choose to work in health care, and we should be doing everything feasible to ensure that we are protecting our patients and keeping our coworkers safe.”

“Whether you are a health care professional or not, I would urge everyone to get the COVID-19 vaccine, especially as cases across the country continue to rise,” Dr. Hirschwerk said. “Unequivocally vaccines protect you from the virus.”

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

Internal Centers for Disease Control and Prevention documents support the high transmission rate of the Delta variant and put the risk in easier to understand terms.

In addition, the agency released a new study that shows that breakthrough infections in the vaccinated make people about as contagious as those who are unvaccinated. The new report, published July 30 in Morbidity and Mortality Weekly Report (MMWR), also reveals that the Delta variant likely causes more severe COVID-19 illness.

Given these recent findings, the internal CDC slide show advises that the agency  should “acknowledge the war has changed.”
 

A ‘pivotal discovery’

CDC Director Rochelle Walensky, MD, MPH, said in a statement that the MMWR report demonstrates “that [D]elta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people.

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with [D]elta can transmit the virus,” she added. “This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation.”

The investigators analyzed 469 COVID-19 cases reported in Massachusetts residents July 3 through 17, 2021. The infections were associated with an outbreak following multiple events and large gatherings in Provincetown in that state’s easternmost Barnstable County, also known as Cape Cod.

Notably, 346 infections, or 74%, of the cases occurred in fully vaccinated individuals. This group had a median age of 42, and 87% were male. Also, 79% of the breakthrough infections were symptomatic.

Researchers also identified the Delta variant in 90% of 133 specimens collected for analysis. Furthermore, viral loads were about the same between samples taken from people who were fully vaccinated and those who were not.

Four of the five people hospitalized were fully vaccinated. No deaths were reported. 

The publication of these results was highly anticipated following the CDC’s updated mask recommendations on July 27.

Outside the scope of the MMWR report is the total number of cases associated with the outbreak, including visitors from outside Massachusetts, which now approach 900 infections, NBC Boston reported.
 

‘Very sobering’ data

“The new information from the CDC around the [D]elta variant is very sobering,” David Hirschwerk, MD, infectious disease specialist at Northwell Health in New Hyde Park, N.Y., said in an interview.

“The CDC is trying to convey and present this uncertain situation clearly to the public based on new, accumulated data,” he said. For example, given the evidence for higher contagiousness of the Delta variant, Dr. Hirschwerk added, “there will be situations where vaccinated people get infected, because the amount of the virus overwhelms the immune protection.

“What is new that is concerning is that people who are vaccinated still have the potential to transmit the virus to the same degree,” he said.

The MMWR study “helps us better understand the question related to whether or not a person who has completed a COVID-19 series can spread the infection,” agreed Michelle Barron, MD, a professor in the division of infectious disease at the University of Colorado, Aurora.

“The message is that, because the [D]elta variant is much more contagious than the original strain, unvaccinated persons need to get vaccinated because it is nearly impossible to avoid the virus indefinitely,” Michael Lin, MD, MPH, infectious diseases specialist and epidemiologist at Rush University Medical Center, Chicago, said when asked to comment.

The new data highlight “that vaccinated persons, if they become sick, should still seek COVID-19 testing and should still isolate, as they are likely contagious,” Dr. Lin added.
 

More contagious than other infections

The internal CDC slide presentation also puts the new transmission risk in simple terms. Saying that the Delta variant is about as contagious as chicken pox, for example, immediately brings back vivid memories for some of staying indoors and away from friends during childhood or teenage outbreaks.

“A lot of people will remember getting chicken pox and then having their siblings get it shortly thereafter,” Dr. Barron said. “The only key thing to note is that this does not mean that the COVID-19 [D]elta variant mechanism of spread is the same as chicken pox and Ebola. The primary means of spread of COVID-19, even the Delta variant, is via droplets.”

This also means each person infected with the Delta variant could infect an average of eight or nine others.

In contrast, the original strain of the SARS-CoV-2 virus was about as infectious as the common cold. In other words, someone was likely to infect about two other people on average.

In addition to the cold, the CDC notes that the Delta variant is now more contagious than Ebola, the seasonal flu, or small pox.

These Delta variant comparisons are one tangible way of explaining why the CDC on July 27 recommended a return to masking in schools and other indoor spaces for people – vaccinated and unvaccinated – in about 70% of the counties across the United States.

In comparing the Delta variant with other infections, “I think the CDC is trying to help people understand a little bit better the situation we now face since the information is so new. We are in a very different position now than just a few weeks ago, and it is hard for people to accept this,” Dr. Hirschwerk said.

The Delta variant is so different that the CDC considers it almost acting like a new virus altogether.

The CDC’s internal documents were first released by The Washington Post on July 29. The slides cite communication challenges for the agency to continue promoting vaccination while also acknowledging that breakthrough cases are occurring and therefore the fully vaccinated, in some instances, are likely infecting others.

Moving back to science talk, the CDC used the recent outbreak in Barnstable County as an example. The cycle threshold, or Ct values, a measure of viral load, were about the same between 80 vaccinated people linked to the outbreak who had a mean Ct value of 21.9, compared with 65 other unvaccinated people with a Ct of 21.5.

Many experts are quick to note that vaccination remains essential, in part because a vaccinated person also walks around with a much lower risk for severe outcomes, hospitalization, and death. In the internal slide show, the CDC points out that vaccination reduces the risk for infection threefold.

“Even with this high amount of virus, [the Delta variant] did not necessarily make the vaccinated individuals as sick,” Dr. Barron said.

In her statement, Dr. Walensky credited collaboration with the Commonwealth of Massachusetts Department of Public Health and the CDC for the new data. She also thanked the residents of Barnstable County for participating in interviews done by contact tracers and their willingness to get tested and adhere to safety protocols after learning of their exposure.
 

Next moves by CDC?

The agency notes that next steps include consideration of prevention measures such as vaccine mandates for healthcare professionals to protect vulnerable populations, universal masking for source control and prevention, and reconsidering other community mitigation strategies.

Asked if this potential policy is appropriate and feasible, Dr. Lin said, “Yes, I believe that every person working in health care should be vaccinated for COVID-19, and it is feasible.”

Dr. Barron agreed as well. “We as health care providers choose to work in health care, and we should be doing everything feasible to ensure that we are protecting our patients and keeping our coworkers safe.”

“Whether you are a health care professional or not, I would urge everyone to get the COVID-19 vaccine, especially as cases across the country continue to rise,” Dr. Hirschwerk said. “Unequivocally vaccines protect you from the virus.”

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

People who are seen after a patient with an influenzalike illness are 31.8% more likely to return to a their doctor’s office within 2 weeks with similar symptoms, new research shows.

Prior research has examined the issue of hospital-acquired infections. A 2014 study published in the New England Journal of Medicine, for example, found that 4% of hospitalized patients acquired a health care–associated infection during their stay. Furthermore, the Centers for Disease Control and Prevention estimates that, on any given day, one in 31 hospital patients has at least one health care–associated infection. However, researchers for the new study, published in Health Affairs, said evidence about the risk of acquiring respiratory viral infections in medical office settings is limited.

“Hospital-acquired infections has been a problem for a while,” study author Hannah Neprash, PhD, of the department of health policy and management at the University of Minnesota School of Public Health, Minneapolis, said in an interview. “However, there’s never been a similar study of whether a similar phenomenon happens in physician offices. This is especially relevant now when we’re dealing with respiratory infections.”

Methods and results

For the new study, Dr. Neprash and her colleagues analyzed deidentified billing and scheduling data from 2016-2017 for 105,462,600 outpatient visits that occurred at 6,709 office-based primary care practices. They used the World Health Organization case definition for influenzalike illness “to capture cases in which the physician may suspect this illness even if a specific diagnosis code was not present.” Their control conditions included exposure to urinary tract infections and back pain.

Doctor visits were considered unexposed if they were scheduled to start at least 90 minutes before the first influenzalike illness visit of the day. They were considered exposed if they were scheduled to start at the same time or after the first influenzalike illness visit of the day at that practice.

Researchers quantified whether exposed patients were more likely to return with a similar illness in the next 2 weeks, compared with nonexposed patients seen earlier in the day

They found that 2.7 patients per 1,000 returned within 2 weeks with an influenzalike illness.

Patients were more likely to return with influenzalike illness if their visit occurred after an influenzalike illness visit versus before, the researchers said.

The authors of the paper said their new research highlights the importance of infection control in health care settings, including outpatient offices.

Where did the exposure occur?

Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis, Tenn., said he was not surprised by the findings, but noted that it’s hard to say if the exposure to influenzalike illnesses happened in the office or in the community.

“If you start to see individuals with influenza in your office it’s because [there’s influenza] in the community,” Dr. Hijano explained. “So that means that you will have more patients coming in with influenza.”

To reduce the transmission of infections, Dr. Neprash suggested that doctors’ offices follow the CDC guidelines for indoor conduct, which include masking, washing hands, and “taking appropriate infection control measures.”

So potentially masking within offices is a way to minimize transmission between whatever people are there to be seen when it’s contagious, Dr. Neprash said.

“Telehealth really took off in 2020 and it’s unclear what the state of telehealth will be going forward. [These findings] suggest that there’s a patient safety argument for continuing to enable primary care physicians to provide visits either by phone or by video,” he added.

Dr. Hijano thinks it would be helpful for doctors to separate patients with respiratory illnesses from those without respiratory illnesses.

Driver of transmissions

Dr. Neprash suggested that another driver of these transmissions could be doctors not washing their hands, which is a “notorious issue,” and Dr. Hijano agreed with that statement.

“We did know that the hands of physicians and nurses and care providers are the main driver of infections in the health care setting,” Dr. Hijano explained. “I mean, washing your hands properly between encounters is the single best way that any given health care provider can prevent the spread of infections.”

“We have a unique opportunity with COVID-19 to change how these clinics are operating now,” Dr. Hijano said. “Many clinics are actually asking patients to call ahead of time if you have symptoms of a respiratory illness that could be contagious, and those who are not are still mandating the use of mask and physical distance in the waiting areas and limiting the amount of number of patients in any given hour. So I think that those are really big practices that would kind of make an impact in respiratory illness in terms of decreasing transmission in clinics.”

The authors, who had no conflicts of interest said their hope is that their study will help inform policy for reopening outpatient care settings. Dr. Hijano, who was not involved in the study also had no conflicts.

People who are seen after a patient with an influenzalike illness are 31.8% more likely to return to a their doctor’s office within 2 weeks with similar symptoms, new research shows.

Prior research has examined the issue of hospital-acquired infections. A 2014 study published in the New England Journal of Medicine, for example, found that 4% of hospitalized patients acquired a health care–associated infection during their stay. Furthermore, the Centers for Disease Control and Prevention estimates that, on any given day, one in 31 hospital patients has at least one health care–associated infection. However, researchers for the new study, published in Health Affairs, said evidence about the risk of acquiring respiratory viral infections in medical office settings is limited.

“Hospital-acquired infections has been a problem for a while,” study author Hannah Neprash, PhD, of the department of health policy and management at the University of Minnesota School of Public Health, Minneapolis, said in an interview. “However, there’s never been a similar study of whether a similar phenomenon happens in physician offices. This is especially relevant now when we’re dealing with respiratory infections.”

Methods and results

For the new study, Dr. Neprash and her colleagues analyzed deidentified billing and scheduling data from 2016-2017 for 105,462,600 outpatient visits that occurred at 6,709 office-based primary care practices. They used the World Health Organization case definition for influenzalike illness “to capture cases in which the physician may suspect this illness even if a specific diagnosis code was not present.” Their control conditions included exposure to urinary tract infections and back pain.

Doctor visits were considered unexposed if they were scheduled to start at least 90 minutes before the first influenzalike illness visit of the day. They were considered exposed if they were scheduled to start at the same time or after the first influenzalike illness visit of the day at that practice.

Researchers quantified whether exposed patients were more likely to return with a similar illness in the next 2 weeks, compared with nonexposed patients seen earlier in the day

They found that 2.7 patients per 1,000 returned within 2 weeks with an influenzalike illness.

Patients were more likely to return with influenzalike illness if their visit occurred after an influenzalike illness visit versus before, the researchers said.

The authors of the paper said their new research highlights the importance of infection control in health care settings, including outpatient offices.

Where did the exposure occur?

Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis, Tenn., said he was not surprised by the findings, but noted that it’s hard to say if the exposure to influenzalike illnesses happened in the office or in the community.

“If you start to see individuals with influenza in your office it’s because [there’s influenza] in the community,” Dr. Hijano explained. “So that means that you will have more patients coming in with influenza.”

To reduce the transmission of infections, Dr. Neprash suggested that doctors’ offices follow the CDC guidelines for indoor conduct, which include masking, washing hands, and “taking appropriate infection control measures.”

So potentially masking within offices is a way to minimize transmission between whatever people are there to be seen when it’s contagious, Dr. Neprash said.

“Telehealth really took off in 2020 and it’s unclear what the state of telehealth will be going forward. [These findings] suggest that there’s a patient safety argument for continuing to enable primary care physicians to provide visits either by phone or by video,” he added.

Dr. Hijano thinks it would be helpful for doctors to separate patients with respiratory illnesses from those without respiratory illnesses.

Driver of transmissions

Dr. Neprash suggested that another driver of these transmissions could be doctors not washing their hands, which is a “notorious issue,” and Dr. Hijano agreed with that statement.

“We did know that the hands of physicians and nurses and care providers are the main driver of infections in the health care setting,” Dr. Hijano explained. “I mean, washing your hands properly between encounters is the single best way that any given health care provider can prevent the spread of infections.”

“We have a unique opportunity with COVID-19 to change how these clinics are operating now,” Dr. Hijano said. “Many clinics are actually asking patients to call ahead of time if you have symptoms of a respiratory illness that could be contagious, and those who are not are still mandating the use of mask and physical distance in the waiting areas and limiting the amount of number of patients in any given hour. So I think that those are really big practices that would kind of make an impact in respiratory illness in terms of decreasing transmission in clinics.”

The authors, who had no conflicts of interest said their hope is that their study will help inform policy for reopening outpatient care settings. Dr. Hijano, who was not involved in the study also had no conflicts.

People who are seen after a patient with an influenzalike illness are 31.8% more likely to return to a their doctor’s office within 2 weeks with similar symptoms, new research shows.

Prior research has examined the issue of hospital-acquired infections. A 2014 study published in the New England Journal of Medicine, for example, found that 4% of hospitalized patients acquired a health care–associated infection during their stay. Furthermore, the Centers for Disease Control and Prevention estimates that, on any given day, one in 31 hospital patients has at least one health care–associated infection. However, researchers for the new study, published in Health Affairs, said evidence about the risk of acquiring respiratory viral infections in medical office settings is limited.

“Hospital-acquired infections has been a problem for a while,” study author Hannah Neprash, PhD, of the department of health policy and management at the University of Minnesota School of Public Health, Minneapolis, said in an interview. “However, there’s never been a similar study of whether a similar phenomenon happens in physician offices. This is especially relevant now when we’re dealing with respiratory infections.”

Methods and results

For the new study, Dr. Neprash and her colleagues analyzed deidentified billing and scheduling data from 2016-2017 for 105,462,600 outpatient visits that occurred at 6,709 office-based primary care practices. They used the World Health Organization case definition for influenzalike illness “to capture cases in which the physician may suspect this illness even if a specific diagnosis code was not present.” Their control conditions included exposure to urinary tract infections and back pain.

Doctor visits were considered unexposed if they were scheduled to start at least 90 minutes before the first influenzalike illness visit of the day. They were considered exposed if they were scheduled to start at the same time or after the first influenzalike illness visit of the day at that practice.

Researchers quantified whether exposed patients were more likely to return with a similar illness in the next 2 weeks, compared with nonexposed patients seen earlier in the day

They found that 2.7 patients per 1,000 returned within 2 weeks with an influenzalike illness.

Patients were more likely to return with influenzalike illness if their visit occurred after an influenzalike illness visit versus before, the researchers said.

The authors of the paper said their new research highlights the importance of infection control in health care settings, including outpatient offices.

Where did the exposure occur?

Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis, Tenn., said he was not surprised by the findings, but noted that it’s hard to say if the exposure to influenzalike illnesses happened in the office or in the community.

“If you start to see individuals with influenza in your office it’s because [there’s influenza] in the community,” Dr. Hijano explained. “So that means that you will have more patients coming in with influenza.”

To reduce the transmission of infections, Dr. Neprash suggested that doctors’ offices follow the CDC guidelines for indoor conduct, which include masking, washing hands, and “taking appropriate infection control measures.”

So potentially masking within offices is a way to minimize transmission between whatever people are there to be seen when it’s contagious, Dr. Neprash said.

“Telehealth really took off in 2020 and it’s unclear what the state of telehealth will be going forward. [These findings] suggest that there’s a patient safety argument for continuing to enable primary care physicians to provide visits either by phone or by video,” he added.

Dr. Hijano thinks it would be helpful for doctors to separate patients with respiratory illnesses from those without respiratory illnesses.

Driver of transmissions

Dr. Neprash suggested that another driver of these transmissions could be doctors not washing their hands, which is a “notorious issue,” and Dr. Hijano agreed with that statement.

“We did know that the hands of physicians and nurses and care providers are the main driver of infections in the health care setting,” Dr. Hijano explained. “I mean, washing your hands properly between encounters is the single best way that any given health care provider can prevent the spread of infections.”

“We have a unique opportunity with COVID-19 to change how these clinics are operating now,” Dr. Hijano said. “Many clinics are actually asking patients to call ahead of time if you have symptoms of a respiratory illness that could be contagious, and those who are not are still mandating the use of mask and physical distance in the waiting areas and limiting the amount of number of patients in any given hour. So I think that those are really big practices that would kind of make an impact in respiratory illness in terms of decreasing transmission in clinics.”

The authors, who had no conflicts of interest said their hope is that their study will help inform policy for reopening outpatient care settings. Dr. Hijano, who was not involved in the study also had no conflicts.

The Centers for Disease Control and Prevention is expected to announce in early August that new data shows people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, the New York Times reported on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the New York Times said. The bottom line is that the CDC data shows people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on Jul 29 that the CDC’s updated mask guidance followed an outbreak on Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

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

The Centers for Disease Control and Prevention is expected to announce in early August that new data shows people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, the New York Times reported on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the New York Times said. The bottom line is that the CDC data shows people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on Jul 29 that the CDC’s updated mask guidance followed an outbreak on Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

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

The Centers for Disease Control and Prevention is expected to announce in early August that new data shows people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, the New York Times reported on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the New York Times said. The bottom line is that the CDC data shows people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on Jul 29 that the CDC’s updated mask guidance followed an outbreak on Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

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

More children admitted to hospitals in 2018 had acute bronchitis than any other diagnosis, according to a recent report from the Agency for Healthcare Research and Quality.

About 7% (99,000) of the 1.47 million nonmaternal, nonneonatal hospital stays in children aged 0-17 years involved a primary diagnosis of acute bronchitis in 2018, representing the leading cause of admissions in boys (154.7 stays per 100,000 population) and the second-leading diagnosis in girls (113.1 stays per 100,000), Kimberly W. McDermott, PhD, and Marc Roemer, MS, said in a statistical brief.

Depressive disorders were the most common primary diagnosis in girls, with a rate of 176.7 stays per 100,000, and the second-leading diagnosis overall, although the rate was less than half that (74.0 per 100,000) in boys. Two other respiratory conditions, asthma and pneumonia, were among the top five for both girls and boys, as was epilepsy, they reported.

The combined rate for all diagnoses was slightly higher for boys, 2,051 per 100,000, compared with 1,922 for girls, they said based on data from the National Inpatient Sample.

“Identifying the most frequent primary conditions for which patients are admitted to the hospital is important to the implementation and improvement of health care delivery, quality initiatives, and health policy,” said Dr. McDermott of IBM Watson Health and Mr. Roemer of the AHRQ.

[email protected]

More children admitted to hospitals in 2018 had acute bronchitis than any other diagnosis, according to a recent report from the Agency for Healthcare Research and Quality.

About 7% (99,000) of the 1.47 million nonmaternal, nonneonatal hospital stays in children aged 0-17 years involved a primary diagnosis of acute bronchitis in 2018, representing the leading cause of admissions in boys (154.7 stays per 100,000 population) and the second-leading diagnosis in girls (113.1 stays per 100,000), Kimberly W. McDermott, PhD, and Marc Roemer, MS, said in a statistical brief.

Depressive disorders were the most common primary diagnosis in girls, with a rate of 176.7 stays per 100,000, and the second-leading diagnosis overall, although the rate was less than half that (74.0 per 100,000) in boys. Two other respiratory conditions, asthma and pneumonia, were among the top five for both girls and boys, as was epilepsy, they reported.

The combined rate for all diagnoses was slightly higher for boys, 2,051 per 100,000, compared with 1,922 for girls, they said based on data from the National Inpatient Sample.

“Identifying the most frequent primary conditions for which patients are admitted to the hospital is important to the implementation and improvement of health care delivery, quality initiatives, and health policy,” said Dr. McDermott of IBM Watson Health and Mr. Roemer of the AHRQ.

[email protected]

More children admitted to hospitals in 2018 had acute bronchitis than any other diagnosis, according to a recent report from the Agency for Healthcare Research and Quality.

About 7% (99,000) of the 1.47 million nonmaternal, nonneonatal hospital stays in children aged 0-17 years involved a primary diagnosis of acute bronchitis in 2018, representing the leading cause of admissions in boys (154.7 stays per 100,000 population) and the second-leading diagnosis in girls (113.1 stays per 100,000), Kimberly W. McDermott, PhD, and Marc Roemer, MS, said in a statistical brief.

Depressive disorders were the most common primary diagnosis in girls, with a rate of 176.7 stays per 100,000, and the second-leading diagnosis overall, although the rate was less than half that (74.0 per 100,000) in boys. Two other respiratory conditions, asthma and pneumonia, were among the top five for both girls and boys, as was epilepsy, they reported.

The combined rate for all diagnoses was slightly higher for boys, 2,051 per 100,000, compared with 1,922 for girls, they said based on data from the National Inpatient Sample.

“Identifying the most frequent primary conditions for which patients are admitted to the hospital is important to the implementation and improvement of health care delivery, quality initiatives, and health policy,” said Dr. McDermott of IBM Watson Health and Mr. Roemer of the AHRQ.

[email protected]

Physicians wearing white coats were rated as significantly more experienced and professional than peers wearing casual attire. Regardless of their attire, however, female physicians were more likely to be judged as appearing less professional and were more likely to be misidentified as medical technicians, physician assistants, or nurses, found research published in JAMA Network Open.

“A white coat with scrubs attire was most preferred for surgeons (mean preference index, 1.3), whereas a white coat with business attire was preferred for family physicians and dermatologists (mean preference indexes, 1.6 and 1.2, respectively; P < .001),” Helen Xun, MD, Johns Hopkins University, Baltimore, and colleagues wrote. “A male model wearing business inner wear with a white coat, fleece jacket, or softshell jacket was perceived as significantly more professional than a female model wearing the same attire (mean professionalism score: male, 65.8; female, 56.2; mean difference in professionalism score: white coat, 12.06; fleece, 7.89; softshell, 8.82; P < .001). ... A male model wearing hospital scrubs or fashion scrubs alone was also perceived as more professional than a female model in the same attire.”

While casual attire, such as fleece or softshell jackets emblazoned with the names of the institution and wearer, has become more popular attire for physicians in recent years, the researchers noted theirs is the first published research to identify associations between gender, attire, and how people distinguish between various health care roles. The study authors launched their web-based survey from May to June 2020 and asked people aged 18 years and older to rate a series of photographs of deidentified models wearing health care attire. Inner wear choices were business attire versus scrubs with and without outer wear options of a long white coat, gray fleece jacket, or black softshell jackets. Survey respondents ranked the images on a 6-point Likert scale with 1 being the least experienced, professional, and friendly and 6 being the most experienced, professional, and friendly. Survey respondents also viewed individual images of male or female models and were asked to rate their professionalism on a scale of 0-100 – with 100 as the “most professional” as well as to identify their profession as either physician, surgeon, nurse, medical technician, or physician assistant.

The study team included 487 (93.3%) of 522 completed surveys in their analyses. Respondents’ mean age was 36.2 years; 260 (53.4%) were female; 372 (76.4%) were White; 33 (6.8%) were Black or African American. Younger respondents and those living in the Western United States who had more exposure to physician casual attire appeared more accepting of it, the authors wrote.

“I remember attending my white-coat ceremony as a medical student, and the symbolism of it all representing me entering the profession. It felt very emotional and heavy and I felt very proud to be there. I also remember taking a ‘selfie’ in my long white coat as a doctor for the first time before my first shift as a resident. But, I’ve also been wearing that same white coat, and a large badge with a ‘DOCTOR’ label on it, and been mistaken by a patient or parent for something other than the physician,” Alexandra M. Sims, a pediatrician and health equity researcher in Cincinnati, said in an interview. “So, I’d really hope that the take-home here is not simply that we must wear our white coats to be considered more professional. I think we have to unpack and dismantle how we’ve even built this notion of ‘professionalism’ in the first place. Women, people of color, and other marginalized groups were certainly not a part of the defining, but we must be a part of the reimagining of an equitable health care profession in this new era.”

As sartorial trends usher in more casual attire, clinicians should redouble efforts to build rapport and enhance communication with patients, such as clarifying team members’ roles when introducing themselves. Dr. Xun and coauthors noted that addressing gender bias is important for all clinicians – not just women – and point to the need for institutional and organizational support for disciplines where gender bias is “especially prevalent,” like surgery. “This responsibility should not be undertaken only by the individuals that experience the biases, which may result in additional cumulative career disadvantages. The promotion of equality and diversity begins with recognition, characterization, and evidence-supported interventions and is a community operation,” Dr. Xun and colleagues concluded.

“I do not equate attire to professionalism or experience, nor is it connected to my satisfaction with the physician. For myself and my daughter, it is the experience of care that ultimately influences our perceptions regarding the professionalism of the physician,” Hala H. Durrah, MTA, parent to a chronically ill child with special health care needs and a Patient and Family Engagement Consultant, said in an interview. “My respect for a physician will ultimately be determined by how my daughter and I were treated, not just from a clinical perspective, but how we felt during those interactions.”

Physicians wearing white coats were rated as significantly more experienced and professional than peers wearing casual attire. Regardless of their attire, however, female physicians were more likely to be judged as appearing less professional and were more likely to be misidentified as medical technicians, physician assistants, or nurses, found research published in JAMA Network Open.

“A white coat with scrubs attire was most preferred for surgeons (mean preference index, 1.3), whereas a white coat with business attire was preferred for family physicians and dermatologists (mean preference indexes, 1.6 and 1.2, respectively; P < .001),” Helen Xun, MD, Johns Hopkins University, Baltimore, and colleagues wrote. “A male model wearing business inner wear with a white coat, fleece jacket, or softshell jacket was perceived as significantly more professional than a female model wearing the same attire (mean professionalism score: male, 65.8; female, 56.2; mean difference in professionalism score: white coat, 12.06; fleece, 7.89; softshell, 8.82; P < .001). ... A male model wearing hospital scrubs or fashion scrubs alone was also perceived as more professional than a female model in the same attire.”

While casual attire, such as fleece or softshell jackets emblazoned with the names of the institution and wearer, has become more popular attire for physicians in recent years, the researchers noted theirs is the first published research to identify associations between gender, attire, and how people distinguish between various health care roles. The study authors launched their web-based survey from May to June 2020 and asked people aged 18 years and older to rate a series of photographs of deidentified models wearing health care attire. Inner wear choices were business attire versus scrubs with and without outer wear options of a long white coat, gray fleece jacket, or black softshell jackets. Survey respondents ranked the images on a 6-point Likert scale with 1 being the least experienced, professional, and friendly and 6 being the most experienced, professional, and friendly. Survey respondents also viewed individual images of male or female models and were asked to rate their professionalism on a scale of 0-100 – with 100 as the “most professional” as well as to identify their profession as either physician, surgeon, nurse, medical technician, or physician assistant.

The study team included 487 (93.3%) of 522 completed surveys in their analyses. Respondents’ mean age was 36.2 years; 260 (53.4%) were female; 372 (76.4%) were White; 33 (6.8%) were Black or African American. Younger respondents and those living in the Western United States who had more exposure to physician casual attire appeared more accepting of it, the authors wrote.

“I remember attending my white-coat ceremony as a medical student, and the symbolism of it all representing me entering the profession. It felt very emotional and heavy and I felt very proud to be there. I also remember taking a ‘selfie’ in my long white coat as a doctor for the first time before my first shift as a resident. But, I’ve also been wearing that same white coat, and a large badge with a ‘DOCTOR’ label on it, and been mistaken by a patient or parent for something other than the physician,” Alexandra M. Sims, a pediatrician and health equity researcher in Cincinnati, said in an interview. “So, I’d really hope that the take-home here is not simply that we must wear our white coats to be considered more professional. I think we have to unpack and dismantle how we’ve even built this notion of ‘professionalism’ in the first place. Women, people of color, and other marginalized groups were certainly not a part of the defining, but we must be a part of the reimagining of an equitable health care profession in this new era.”

As sartorial trends usher in more casual attire, clinicians should redouble efforts to build rapport and enhance communication with patients, such as clarifying team members’ roles when introducing themselves. Dr. Xun and coauthors noted that addressing gender bias is important for all clinicians – not just women – and point to the need for institutional and organizational support for disciplines where gender bias is “especially prevalent,” like surgery. “This responsibility should not be undertaken only by the individuals that experience the biases, which may result in additional cumulative career disadvantages. The promotion of equality and diversity begins with recognition, characterization, and evidence-supported interventions and is a community operation,” Dr. Xun and colleagues concluded.

“I do not equate attire to professionalism or experience, nor is it connected to my satisfaction with the physician. For myself and my daughter, it is the experience of care that ultimately influences our perceptions regarding the professionalism of the physician,” Hala H. Durrah, MTA, parent to a chronically ill child with special health care needs and a Patient and Family Engagement Consultant, said in an interview. “My respect for a physician will ultimately be determined by how my daughter and I were treated, not just from a clinical perspective, but how we felt during those interactions.”

Physicians wearing white coats were rated as significantly more experienced and professional than peers wearing casual attire. Regardless of their attire, however, female physicians were more likely to be judged as appearing less professional and were more likely to be misidentified as medical technicians, physician assistants, or nurses, found research published in JAMA Network Open.

“A white coat with scrubs attire was most preferred for surgeons (mean preference index, 1.3), whereas a white coat with business attire was preferred for family physicians and dermatologists (mean preference indexes, 1.6 and 1.2, respectively; P < .001),” Helen Xun, MD, Johns Hopkins University, Baltimore, and colleagues wrote. “A male model wearing business inner wear with a white coat, fleece jacket, or softshell jacket was perceived as significantly more professional than a female model wearing the same attire (mean professionalism score: male, 65.8; female, 56.2; mean difference in professionalism score: white coat, 12.06; fleece, 7.89; softshell, 8.82; P < .001). ... A male model wearing hospital scrubs or fashion scrubs alone was also perceived as more professional than a female model in the same attire.”

While casual attire, such as fleece or softshell jackets emblazoned with the names of the institution and wearer, has become more popular attire for physicians in recent years, the researchers noted theirs is the first published research to identify associations between gender, attire, and how people distinguish between various health care roles. The study authors launched their web-based survey from May to June 2020 and asked people aged 18 years and older to rate a series of photographs of deidentified models wearing health care attire. Inner wear choices were business attire versus scrubs with and without outer wear options of a long white coat, gray fleece jacket, or black softshell jackets. Survey respondents ranked the images on a 6-point Likert scale with 1 being the least experienced, professional, and friendly and 6 being the most experienced, professional, and friendly. Survey respondents also viewed individual images of male or female models and were asked to rate their professionalism on a scale of 0-100 – with 100 as the “most professional” as well as to identify their profession as either physician, surgeon, nurse, medical technician, or physician assistant.

The study team included 487 (93.3%) of 522 completed surveys in their analyses. Respondents’ mean age was 36.2 years; 260 (53.4%) were female; 372 (76.4%) were White; 33 (6.8%) were Black or African American. Younger respondents and those living in the Western United States who had more exposure to physician casual attire appeared more accepting of it, the authors wrote.

“I remember attending my white-coat ceremony as a medical student, and the symbolism of it all representing me entering the profession. It felt very emotional and heavy and I felt very proud to be there. I also remember taking a ‘selfie’ in my long white coat as a doctor for the first time before my first shift as a resident. But, I’ve also been wearing that same white coat, and a large badge with a ‘DOCTOR’ label on it, and been mistaken by a patient or parent for something other than the physician,” Alexandra M. Sims, a pediatrician and health equity researcher in Cincinnati, said in an interview. “So, I’d really hope that the take-home here is not simply that we must wear our white coats to be considered more professional. I think we have to unpack and dismantle how we’ve even built this notion of ‘professionalism’ in the first place. Women, people of color, and other marginalized groups were certainly not a part of the defining, but we must be a part of the reimagining of an equitable health care profession in this new era.”

As sartorial trends usher in more casual attire, clinicians should redouble efforts to build rapport and enhance communication with patients, such as clarifying team members’ roles when introducing themselves. Dr. Xun and coauthors noted that addressing gender bias is important for all clinicians – not just women – and point to the need for institutional and organizational support for disciplines where gender bias is “especially prevalent,” like surgery. “This responsibility should not be undertaken only by the individuals that experience the biases, which may result in additional cumulative career disadvantages. The promotion of equality and diversity begins with recognition, characterization, and evidence-supported interventions and is a community operation,” Dr. Xun and colleagues concluded.

“I do not equate attire to professionalism or experience, nor is it connected to my satisfaction with the physician. For myself and my daughter, it is the experience of care that ultimately influences our perceptions regarding the professionalism of the physician,” Hala H. Durrah, MTA, parent to a chronically ill child with special health care needs and a Patient and Family Engagement Consultant, said in an interview. “My respect for a physician will ultimately be determined by how my daughter and I were treated, not just from a clinical perspective, but how we felt during those interactions.”

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

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

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

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

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

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