The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster doses Monday, allowing 12- to 15-year-olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the agency’s deliberations.

Regulators also plan to allow both adolescents and adults to seek an extra shot of Pfizer’s vaccine five months after receiving a second dose, instead of the current period of six months. A booster shot is also expected to be authorized for younger children, ages 5 to 11, with immune deficiencies.

The Centers for Disease Control and Prevention’s vaccine advisory committee is planning to meet by the middle of next week to vote on whether to recommend the changes. If the committee agrees with the FDA’s authorizations, Dr. Rochelle Walensky, the CDC director, is expected to promptly endorse the revisions.

The move to expand boosters comes as the highly contagious omicron variant is infecting a record number of Americans with the coronavirus, putting more pressure on hospitals already deluged by COVID-19 patients from the delta variant.

More than 70% of people in the United States 12 years and older are fully vaccinated, according to the CDC. Children can better withstand coronavirus infections but in rare instances still can get very sick and even die. At least 1.8 million adolescents between 12 and 15 years old have tested positive for the virus, according to the CDC.

The FDA had hoped to announce its decision as early as Thursday, the people familiar with the deliberations said, but agreed to wait until Monday because Walensky said she wanted to hear recommendations from her agency’s outside advisory group before signing off on the changes. That group, which has met throughout the pandemic to consider FDA decisions around vaccines, might not meet until Wednesday.

The two agencies share responsibility for setting the nation’s vaccine policy and have worked to present a unified front in their reviews of booster shots. But the FDA has been more willing to act without the advice of its outside advisory committee, with some top officials arguing that the agency needs to respond as quickly as possible in the face of the ongoing public health crisis.

Federal regulators based their decision at least in part on data from Israel that showed no serious safety concerns in thousands of 12- to 15-year-olds who received a third dose of the Pfizer vaccine. There were no reports of myocarditis, a rare side effect seen mostly in younger men that has been linked to the Pfizer and Moderna vaccines. The condition involves inflammation of the heart muscle.

The FDA wants to allow a booster dose as early as five months after the second Pfizer dose in part because Israeli data suggests that the shorter interval is effective, according to people familiar with the government’s deliberations.

One recent South African study showed that the effectiveness of Pfizer’s vaccine against severe illness and hospitalization was about 70% after two doses.

Pfizer and BioNTech, its German partner, have both said their studies show that a third dose is needed to protect against omicron. Dr. Albert Bourla, the CEO of Pfizer, said earlier this month that while two doses may still prevent severe disease from omicron, a third strengthens protection.

Dr. Ugur Sahin, the CEO of BioNTech, said three doses “could still offer a sufficient level of protection from disease of any severity” caused by the variant.

Although the FDA convened its outside advisory committee repeatedly earlier this year, it has not asked the committee for recommendations before its most recent decisions to expand boosters.

Walensky earlier this month endorsed offering Pfizer-BioNTech booster shots to 16- and 17-year-olds without convening her agency’s expert committee. But she was unwilling to do that for younger adolescents, people familiar with the government’s deliberations said.

Some outside experts have argued that by bypassing the outside committees, the CDC and FDA were wrongly limiting public discussion about the evidence to justify expanding the use of boosters.

The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster doses Monday, allowing 12- to 15-year-olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the agency’s deliberations.

The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster doses Monday, allowing 12- to 15-year-olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the agency’s deliberations. Regulators also plan to allow both adolescents and adults to seek an extra shot of Pfizer’s vaccine five months after receiving a second dose, instead of the current period of six months. A booster shot is also expected to be authorized for younger children, ages 5 to 11, with immune deficiencies. The Centers for Disease Control and Prevention’s vaccine advisory committee is planning to meet by the middle of next week to vote on whether to recommend the changes. If the committee agrees with the FDA’s authorizations, Dr. Rochelle Walensky, the CDC director, is expected to promptly endorse the revisions. The move to expand boosters comes as the highly contagious omicron variant is infecting a record number of Americans with the coronavirus, putting more pressure on hospitals already deluged by COVID-19 patients from the delta variant. More than 70% of people in the United States 12 years and older are fully vaccinated, according to the CDC. Children can better withstand coronavirus infections but in rare instances still can get very sick and even die. At least 1.8 million adolescents between 12 and 15 years old have tested positive for the virus, according to the CDC. The FDA had hoped to announce its decision as early as Thursday, the people familiar with the deliberations said, but agreed to wait until Monday because Walensky said she wanted to hear recommendations from her agency’s outside advisory group before signing off on the changes. That group, which has met throughout the pandemic to consider FDA decisions around vaccines, might not meet until Wednesday. The two agencies share responsibility for setting the nation’s vaccine policy and have worked to present a unified front in their reviews of booster shots. But the FDA has been more willing to act without the advice of its outside advisory committee, with some top officials arguing that the agency needs to respond as quickly as possible in the face of the ongoing public health crisis. Federal regulators based their decision at least in part on data from Israel that showed no serious safety concerns in thousands of 12- to 15-year-olds who received a third dose of the Pfizer vaccine. There were no reports of myocarditis, a rare side effect seen mostly in younger men that has been linked to the Pfizer and Moderna vaccines. The condition involves inflammation of the heart muscle. The FDA wants to allow a booster dose as early as five months after the second Pfizer dose in part because Israeli data suggests that the shorter interval is effective, according to people familiar with the government’s deliberations. One recent South African study showed that the effectiveness of Pfizer’s vaccine against severe illness and hospitalization was about 70% after two doses. Pfizer and BioNTech, its German partner, have both said their studies show that a third dose is needed to protect against omicron. Dr. Albert Bourla, the CEO of Pfizer, said earlier this month that while two doses may still prevent severe disease from omicron, a third strengthens protection. Dr. Ugur Sahin, the CEO of BioNTech, said three doses “could still offer a sufficient level of protection from disease of any severity” caused by the variant. Although the FDA convened its outside advisory committee repeatedly earlier this year, it has not asked the committee for recommendations before its most recent decisions to expand boosters. Walensky earlier this month endorsed offering Pfizer-BioNTech booster shots to 16- and 17-year-olds without convening her agency’s expert committee. But she was unwilling to do that for younger adolescents, people familiar with the government’s deliberations said. Some outside experts have argued that by bypassing the outside committees, the CDC and FDA were wrongly limiting public discussion about the evidence to justify expanding the use of boosters.

FDA plans to allow 12- to 15-year-olds to receive Pfizer boosters

As concerns grow about the impact of the new Omicron variant, Pfizer announced on Tuesday it was seeking US authorization for booster shots for adolescents aged 16 and 17.

So far, FDA has approved emergency use authorizations (EUAs) for boosters only for those aged 18 and over, six months after the primary series of the Pfizer or Moderna Covid vaccine, or two months after the Johnson &amp; Johnson booster.

Also read |&nbsp;<a href="https://www.wionews.com/science/will-the-vaccines-stop-omicron-scientists-are-racing-to-find-out-432692">Will the vaccines stop Omicron? Scientists are racing to find out.</a>

"Today, we submitted a request to the @US_FDA to expand the emergency use authorization of a booster dose of our COVID-19 vaccine to include 16- and 17-year-olds," Pfizer CEO Albert Bourla wrote on Twitter.

"It is our hope to provide strong protection for as many people as possible, particularly in light of the new variant."&nbsp;

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false">
<blockquote class="twitter-tweet">
Today, we submitted a request to the <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> to expand the emergency use authorization of a booster dose of our COVID-19 vaccine to include 16- and 17-year-olds. It is our hope to provide strong protection for as many people as possible, particularly in light of the new variant.
— Albert Bourla (@AlbertBourla) <a href="https://twitter.com/AlbertBourla/status/1465804576372703241?ref_src=twsrc%5Etfw">November 30, 2021</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
<a class="close-mark close-div" href="#" id="jqclosemark">×</a></div>

Due to the mutation pattern detected on the Omicron variant, experts fear that protection offered by the current vaccine generation may be compromised.

Within a few weeks, lab results will reveal whether or not the hypothesis is correct. However, US health authorities are insisting that everyone who is eligible for a booster get one, to ensure protection against severe Covid, even if not infection itself.

While Omicron has been detected in more than a dozen countries, it has yet to be detected in the United States, where Delta accounts for more than 99 per cent of all infections.

Watch |&nbsp;Gravitas: India helps Africa amid Omicron alert

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/gravitas-india-helps-africa-amid-omicron-alert-433080/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

There is disagreement among health experts regarding boosters for healthy teens, who are at less risk of developing severe Covid, especially when males exposed to the Pfizer and Moderna messenger RNA vaccines, are at higher risk of developing vaccine-linked myocarditis.

"If the FDA takes this action, it will be a total gamble," tweeted Vinay Prasad, a haematologist-oncologist at the University of San Francisco with expertise in biostatistics and epidemiology.

<div class="ui-state-default" contenteditable="false">
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<blockquote class="twitter-tweet">
As long as it is so uncertain, the decision must be made solely on the basis of what is best for those actually getting the shot. 
 
If the FDA takes this action it will be a total gamble 
 
it won't be the first one. 
 
But each of these gambles is dangerous.
— Vinay Prasad, MD MPH 🎙️📷 (@VPrasadMDMPH) <a href="https://twitter.com/VPrasadMDMPH/status/1465712589447446540?ref_src=twsrc%5Etfw">November 30, 2021</a></blockquote>
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(With inputs from agencies)

As concerns grow about the impact of the new Omicron variant, Pfizer announced on Tuesday it was seeking US authorization for booster shots for adolescents aged 16 and 17.

As concerns grow about the impact of the new Omicron variant, Pfizer announced on Tuesday it was seeking US authorization for booster shots for adolescents aged 16 and 17. So far, FDA has approved emergency use authorizations (EUAs) for boosters only for those aged 18 and over, six months after the primary series of the Pfizer or Moderna Covid vaccine, or two months after the Johnson & Johnson booster. Also read | Will the vaccines stop Omicron? Scientists are racing to find out. "Today, we submitted a request to the @US_FDA to expand the emergency use authorization of a booster dose of our COVID-19 vaccine to include 16- and 17-year-olds," Pfizer CEO Albert Bourla wrote on Twitter. "It is our hope to provide strong protection for as many people as possible, particularly in light of the new variant." Today, we submitted a request to the @US_FDA to expand the emergency use authorization of a booster dose of our COVID-19 vaccine to include 16- and 17-year-olds. It is our hope to provide strong protection for as many people as possible, particularly in light of the new variant. — Albert Bourla (@AlbertBourla) November 30, 2021 × Due to the mutation pattern detected on the Omicron variant, experts fear that protection offered by the current vaccine generation may be compromised. Within a few weeks, lab results will reveal whether or not the hypothesis is correct. However, US health authorities are insisting that everyone who is eligible for a booster get one, to ensure protection against severe Covid, even if not infection itself. While Omicron has been detected in more than a dozen countries, it has yet to be detected in the United States, where Delta accounts for more than 99 per cent of all infections. Watch | Gravitas: India helps Africa amid Omicron alert There is disagreement among health experts regarding boosters for healthy teens, who are at less risk of developing severe Covid, especially when males exposed to the Pfizer and Moderna messenger RNA vaccines, are at higher risk of developing vaccine-linked myocarditis. "If the FDA takes this action, it will be a total gamble," tweeted Vinay Prasad, a haematologist-oncologist at the University of San Francisco with expertise in biostatistics and epidemiology. As long as it is so uncertain, the decision must be made solely on the basis of what is best for those actually getting the shot. If the FDA takes this action it will be a total gamble it won't be the first one. But each of these gambles is dangerous. — Vinay Prasad, MD MPH 🎙️📷 (@VPrasadMDMPH) November 30, 2021 × (With inputs from agencies)

Pfizer seeks US FDA approval for Covid boosters for teens aged 16-17

US President Joe Biden on Monday took a COVID-19 booster shot as he urged Americans to take the vaccine.

It was the US president's third Pfizer dose after the government approved booster doses for those over 65.

"I know it doesn't look like it, but I am over 65," Biden said while imploring others to complete their coronavirus vaccine shots.

<a href="https://www.wionews.com/world/new-york-hospitals-face-possible-mass-firings-as-workers-spurn-vaccines-415880">Also Read:&nbsp;New York hospitals face possible mass firings as workers spurn vaccines</a>

The US president had taken the first Pfizer vaccine shot in December last year and then again in January this year to complete his two doses.&nbsp;

The US president informed that at least 77 per cent of Americans had taken both the vaccine shots,&nbsp;however, a large number of people were still unvaccinated and were refusing to take shots. Biden announced that over 60 million Americans are set to take the Pfizer booster shots in the country.

<a href="https://www.wionews.com/world/us-fda-authorises-third-dose-of-pfizer-covid-19-vaccine-for-older-americans-415159">Also Read:&nbsp;US FDA authorises third dose of Pfizer COVID-19 vaccine for older Americans</a>

The US president informed that&nbsp;he didn't suffer from any side effects after the first or the second dose.

The president said the United States will continue to fund Covax and give away&nbsp;vaccines to the world so that "everyone in the world" gets it.

<a href="https://www.wionews.com/world/france-to-double-covid-19-vaccine-doses-for-poorer-countries-416113">Also Read:&nbsp;France to double COVID-19 vaccine doses for poorer countries</a>

"We play our part, the largest part in the world to get everyone vaccinated," Biden said after getting the booster dose.

However, Biden maintained that a "quarter of the country can't go unvaccinated" as America remains open and schools reopen.

"Let me be clear -&nbsp;boosters are important but the most important thing we need to do is get more people vaccinated," the president said.

(With inputs from Agencies)

US President Joe Biden on Monday took a COVID-19 booster shot as he urged Americans to take the vaccine. It was the US president's third Pfizer dose after the government approved booster doses for those over 65.

US President Joe Biden on Monday took a COVID-19 booster shot as he urged Americans to take the vaccine. It was the US president's third Pfizer dose after the government approved booster doses for those over 65. "I know it doesn't look like it, but I am over 65," Biden said while imploring others to complete their coronavirus vaccine shots. Also Read: New York hospitals face possible mass firings as workers spurn vaccines The US president had taken the first Pfizer vaccine shot in December last year and then again in January this year to complete his two doses. The US president informed that at least 77 per cent of Americans had taken both the vaccine shots, however, a large number of people were still unvaccinated and were refusing to take shots. Biden announced that over 60 million Americans are set to take the Pfizer booster shots in the country. Also Read: US FDA authorises third dose of Pfizer COVID-19 vaccine for older Americans The US president informed that he didn't suffer from any side effects after the first or the second dose. The president said the United States will continue to fund Covax and give away vaccines to the world so that "everyone in the world" gets it. Also Read: France to double COVID-19 vaccine doses for poorer countries "We play our part, the largest part in the world to get everyone vaccinated," Biden said after getting the booster dose. However, Biden maintained that a "quarter of the country can't go unvaccinated" as America remains open and schools reopen. "Let me be clear - boosters are important but the most important thing we need to do is get more people vaccinated," the president said. (With inputs from Agencies)

'Can't go unvaccinated': President Biden gets vaccine booster shot

Israeli President Isaac Herzog receives the third dose of the Pfizer vaccine&nbsp;kicking off a campaign to give booster doses to people aged over 60 as part of efforts to slow the spread of the highly contagious Delta variant.

He said he was proud to launch the booster vaccination initiative "which is so vital to enable normal circumstances of life as much as possible in this very challenging pandemic". Herzog's wife Michal also received a shot.

The couple were accompanied by Prime Minister Naftali Bennett, who urged the importance of booster shots in fighting the COVID-19 pandemic and pledged that&nbsp;Israel&nbsp;would share all the information it gleans from the public inoculation rollout.

"Israel&nbsp;is a pioneer in going ahead with the third dose for older people of the age of 60 and above. The fight against the COVID pandemic is a global fight. The only way we can defeat COVID is together," Bennett said.

Israel's digitised medical databases allowed for rapid large-scale studies, and its initial vaccine rollout of the jab was among the world's fastest.

The country was quick to roll out its vaccination campaign and had dropped many restrictions on public gatherings in June, but infections soared, and masks are once again mandatory in enclosed public places.

Daily new infections have spiked to more than 2,000, up from a handful of cases per day a few months ago and about 160 people are currently hospitalised with severe symptoms. More than 6,400 people have died from the virus.

About 55 percent of its nine million population has been double vaccinated, most with the Pfizer-BioNTech jab, thanks to a massive campaign launched in late December after an agreement with its developers.

Pfizer, which produces the vaccine used in&nbsp;Israel, has said research shows that a third dose has neutralising effects against the Delta variant of Covid.

But the US Food and Drug Administration, whose recommendations&nbsp;Israel&nbsp;generally follows, has yet to give the green light to administering a third dose to the elderly.

(With inputs from agencies)

Israeli President Isaac Herzog receives the third dose of the Pfizer vaccine kicking off a campaign to give booster doses to people aged over 60 as part of efforts to slow the spread of the highly contagious Delta variant.

Israeli President Isaac Herzog receives the third dose of the Pfizer vaccine kicking off a campaign to give booster doses to people aged over 60 as part of efforts to slow the spread of the highly contagious Delta variant. He said he was proud to launch the booster vaccination initiative "which is so vital to enable normal circumstances of life as much as possible in this very challenging pandemic". Herzog's wife Michal also received a shot. The couple were accompanied by Prime Minister Naftali Bennett, who urged the importance of booster shots in fighting the COVID-19 pandemic and pledged that Israel would share all the information it gleans from the public inoculation rollout. "Israel is a pioneer in going ahead with the third dose for older people of the age of 60 and above. The fight against the COVID pandemic is a global fight. The only way we can defeat COVID is together," Bennett said. Israel's digitised medical databases allowed for rapid large-scale studies, and its initial vaccine rollout of the jab was among the world's fastest. The country was quick to roll out its vaccination campaign and had dropped many restrictions on public gatherings in June, but infections soared, and masks are once again mandatory in enclosed public places. Daily new infections have spiked to more than 2,000, up from a handful of cases per day a few months ago and about 160 people are currently hospitalised with severe symptoms. More than 6,400 people have died from the virus. About 55 percent of its nine million population has been double vaccinated, most with the Pfizer-BioNTech jab, thanks to a massive campaign launched in late December after an agreement with its developers. Pfizer, which produces the vaccine used in Israel, has said research shows that a third dose has neutralising effects against the Delta variant of Covid. But the US Food and Drug Administration, whose recommendations Israel generally follows, has yet to give the green light to administering a third dose to the elderly. (With inputs from agencies)

Israeli President Isaac Herzog gets third dose of Pfizer vaccine, urges boosters for over-60s

Representatives of Pfizer met privately with senior US&nbsp;scientists and regulators Monday to press their case for swift authorization of coronavirus booster vaccines, amid growing public confusion about whether they will be needed and pushback from federal health officials who say the extra doses are not necessary now.

The high-level online meeting, which lasted an hour and involved Pfizer’s chief scientific officer briefing virtually every top doctor in the federal government, came on the same day Israel started administering third doses of the Pfizer-BioNTech vaccine to heart transplant patients and others with compromised immune systems. Officials said after the meeting that more data — and possibly several more months — would be needed before regulators could determine whether booster shots were necessary.

The twin developments underscored the intensifying debate about whether booster shots are needed in the United States, at what point and for whom. Many American experts, including Dr. Anthony Fauci, President Joe Biden’s chief medical adviser for the pandemic, have said there is insufficient evidence yet that boosters are necessary. Some, though, say Israel’s move may foreshadow a government decision to at least recommend them for the vulnerable.

Pfizer is gathering information on antibody responses in those who receive a third dose, as well as data from Israel, and expects to submit at least some of that to the Food and Drug Administration in the coming weeks in a formal request to broaden the emergency authorization for its coronavirus vaccine.

But the final decision on booster shots, several officials said after the meeting, will also depend on real-world information gathered by the Centers for Disease Control and Prevention about breakthrough infections — those occurring in vaccinated people — that cause serious disease or hospitalization.

And any recommendations about booster shots are likely to be calibrated, even within age groups, officials said. For example, if booster shots are recommended, they might go first to nursing home residents who received their vaccines in late 2020 or early 2021, while elderly people who received their first shots in the spring might have a longer wait. And then there is the question of what kind of booster: a third dose of the original vaccine, or perhaps a shot tailored to the highly infectious delta variant, which is surging in the United States.

“It was an interesting meeting. They shared their data. There wasn’t anything resembling a decision,” Fauci said in a brief interview Monday evening, adding, “This is just one piece of a much bigger puzzle, and it’s one part of the data, so there isn’t a question of a convincing case one way or the other.”

Amy Rose, a Pfizer spokesperson, said in a statement, “We had a productive meeting with U.S. public health officials on the elements of our research program and the preliminary booster data.”

The Department of Health and Human Services, which convened the meeting, issued its own statement reiterating the administration’s stance. “At this time, fully vaccinated Americans do not need a booster shot,” it said.

With less than half of the United States population fully vaccinated, some experts said Monday that the country needed to remain focused on getting all Americans their first dose. The FDA's most important task, they said, is to increase public confidence by granting full approval to the coronavirus vaccines in use, which for now are authorized on an emergency basis.

“At this point, the most important booster we need is to get people vaccinated,” said Dr. Carlos del Rio, an infectious disease expert at Emory University in Atlanta. The booster doses in Israel, he added, “will help us answer some questions, but at the end of the day I don’t agree with what they’re doing. I think it’s awfully premature.”

Within the Biden administration, some fear that if Americans are convinced that coronavirus vaccines provide only short-lived immunity before requiring a booster, they will be less likely to accept a shot. But those concerns could fall by the wayside if new data from Israel, expected in the next several weeks, shows conclusively that immunity wanes after six to eight months, significantly raising the risks for the elderly or other vulnerable populations.

The administration convened Monday’s session in response to last week’s announcement by Pfizer and its German partner, BioNTech, that they were developing a version of their vaccine that targets the delta variant, and reporting promising results from studies of people who received a third dose of the original vaccine six months after the second.

The new data is not yet published or peer reviewed, but when the companies announced that they would submit data to the FDA for authorization of booster shots, it caught the Biden White House by surprise.

In an unusual joint statement Thursday evening, hours after the Pfizer-BioNTech announcement, the FDA and the CDC pushed back.

“Americans who have been fully vaccinated do not need a booster shot at this time,” the statement said, adding, “We are prepared for booster doses if and when the science demonstrates that they are needed.”

The move may make good business sense for Pfizer-BioNTech. Since the onset of the pandemic, the partner companies have pursued a “get to market first” strategy in manufacturing and marketing their vaccine.

The companies did not take federal money or participate in Operation Warp Speed, former President Donald Trump’s fast-track vaccine initiative. They were not only the first to win FDA authorization for their coronavirus vaccine, the first to use novel mRNA technology, but also the first to gain authorization for their vaccine’s use in adolescents.

The strategy has “paid off as handsomely as anyone could ask for,” said Steve Brozak, president of WBB Securities, a research investment bank focused on biotechnology.

Last week, Pfizer and BioNTech said a booster given six months after the second dose of the vaccine increased the potency of antibodies against the original virus and the beta variant by five- to tenfold. But antibody levels may not be the best biological measurement of the need for booster doses, according to experts, who say it is no surprise that antibodies would increase after taking a third dose.

“Antibody response is not the only measure of immune protection,” said Dr. Leana S. Wen, a former health commissioner for Baltimore. “There have been multiple studies that suggest these vaccines also stimulate B cell and T cell immunity, so even if there isn’t as much antibody, that doesn’t mean someone isn’t protected.”

In Israel, the government agreed to provide Pfizer with data on its vaccine recipients, and Pfizer has been matching the Israeli data with its own laboratory tests on antibody responses. Some people familiar with the data say that taken together, the two data sets indicate that immunity is waning among the vaccinated after roughly six to eight months, leading to a growing number of breakthrough infections.

The attendees at Monday’s session amounted to a who’s who of government doctors: Fauci; Dr. Rochelle Walensky, the director of the CDC; Dr. Francis Collins, the director of the National Institutes of Health; Dr. Vivek Murthy, the surgeon general; Dr. Rachel Levine, the assistant secretary for health; Dr. Janet Woodcock, the acting FDA commissioner; Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research; and Dr. David Kessler, a former FDA commissioner who is heading the Biden administration’s vaccine distribution effort, among others.

Del Rio of Emory University complained about Monday’s meeting being conducted in private instead of Pfizer presenting its data publicly to the CDC’s advisory committee on vaccine practices, which will ultimately recommend whether booster shots are necessary.

Slightly more than two-thirds of American adults — 67.7% — have had at least one COVID-19 shot, according to the CDC. That figure falls short of the Biden administration’s goals; the president had hoped to have 70% of adults at least partially vaccinated by July 4.

Still, the national vaccination campaign has made clear that the vaccine succeeds at preventing disease, and studies suggest that vaccines remain effective against the delta variant. Outbreaks are occurring in areas with low rates of vaccination, and the national caseload has ticked up recently; according to a New York Times database.

World Health Organization officials emphasized Monday the importance of prioritizing global vaccine production and distribution over the development of boosters in light of the stark gaps among countries’ vaccination programs.

“It’s not to say one or the other; it’s putting things in a crisis in order,” said Dr. Michael Ryan, executive director of the organization’s health emergencies program, in reference to addressing what the organization calls a two-tier pandemic.

Representatives of Pfizer met privately with senior US scientists and regulators Monday to press their case for swift authorization of coronavirus booster vaccines, amid growing public confusion about whether they will be needed and pushback from federal health officials who say the extra doses are not necessary now.

Representatives of Pfizer met privately with senior US scientists and regulators Monday to press their case for swift authorization of coronavirus booster vaccines, amid growing public confusion about whether they will be needed and pushback from federal health officials who say the extra doses are not necessary now. The high-level online meeting, which lasted an hour and involved Pfizer’s chief scientific officer briefing virtually every top doctor in the federal government, came on the same day Israel started administering third doses of the Pfizer-BioNTech vaccine to heart transplant patients and others with compromised immune systems. Officials said after the meeting that more data — and possibly several more months — would be needed before regulators could determine whether booster shots were necessary. The twin developments underscored the intensifying debate about whether booster shots are needed in the United States, at what point and for whom. Many American experts, including Dr. Anthony Fauci, President Joe Biden’s chief medical adviser for the pandemic, have said there is insufficient evidence yet that boosters are necessary. Some, though, say Israel’s move may foreshadow a government decision to at least recommend them for the vulnerable. Pfizer is gathering information on antibody responses in those who receive a third dose, as well as data from Israel, and expects to submit at least some of that to the Food and Drug Administration in the coming weeks in a formal request to broaden the emergency authorization for its coronavirus vaccine. But the final decision on booster shots, several officials said after the meeting, will also depend on real-world information gathered by the Centers for Disease Control and Prevention about breakthrough infections — those occurring in vaccinated people — that cause serious disease or hospitalization. And any recommendations about booster shots are likely to be calibrated, even within age groups, officials said. For example, if booster shots are recommended, they might go first to nursing home residents who received their vaccines in late 2020 or early 2021, while elderly people who received their first shots in the spring might have a longer wait. And then there is the question of what kind of booster: a third dose of the original vaccine, or perhaps a shot tailored to the highly infectious delta variant, which is surging in the United States. “It was an interesting meeting. They shared their data. There wasn’t anything resembling a decision,” Fauci said in a brief interview Monday evening, adding, “This is just one piece of a much bigger puzzle, and it’s one part of the data, so there isn’t a question of a convincing case one way or the other.” Amy Rose, a Pfizer spokesperson, said in a statement, “We had a productive meeting with U.S. public health officials on the elements of our research program and the preliminary booster data.” The Department of Health and Human Services, which convened the meeting, issued its own statement reiterating the administration’s stance. “At this time, fully vaccinated Americans do not need a booster shot,” it said. With less than half of the United States population fully vaccinated, some experts said Monday that the country needed to remain focused on getting all Americans their first dose. The FDA's most important task, they said, is to increase public confidence by granting full approval to the coronavirus vaccines in use, which for now are authorized on an emergency basis. “At this point, the most important booster we need is to get people vaccinated,” said Dr. Carlos del Rio, an infectious disease expert at Emory University in Atlanta. The booster doses in Israel, he added, “will help us answer some questions, but at the end of the day I don’t agree with what they’re doing. I think it’s awfully premature.” Within the Biden administration, some fear that if Americans are convinced that coronavirus vaccines provide only short-lived immunity before requiring a booster, they will be less likely to accept a shot. But those concerns could fall by the wayside if new data from Israel, expected in the next several weeks, shows conclusively that immunity wanes after six to eight months, significantly raising the risks for the elderly or other vulnerable populations. The administration convened Monday’s session in response to last week’s announcement by Pfizer and its German partner, BioNTech, that they were developing a version of their vaccine that targets the delta variant, and reporting promising results from studies of people who received a third dose of the original vaccine six months after the second. The new data is not yet published or peer reviewed, but when the companies announced that they would submit data to the FDA for authorization of booster shots, it caught the Biden White House by surprise. In an unusual joint statement Thursday evening, hours after the Pfizer-BioNTech announcement, the FDA and the CDC pushed back. “Americans who have been fully vaccinated do not need a booster shot at this time,” the statement said, adding, “We are prepared for booster doses if and when the science demonstrates that they are needed.” The move may make good business sense for Pfizer-BioNTech. Since the onset of the pandemic, the partner companies have pursued a “get to market first” strategy in manufacturing and marketing their vaccine. The companies did not take federal money or participate in Operation Warp Speed, former President Donald Trump’s fast-track vaccine initiative. They were not only the first to win FDA authorization for their coronavirus vaccine, the first to use novel mRNA technology, but also the first to gain authorization for their vaccine’s use in adolescents. The strategy has “paid off as handsomely as anyone could ask for,” said Steve Brozak, president of WBB Securities, a research investment bank focused on biotechnology. Last week, Pfizer and BioNTech said a booster given six months after the second dose of the vaccine increased the potency of antibodies against the original virus and the beta variant by five- to tenfold. But antibody levels may not be the best biological measurement of the need for booster doses, according to experts, who say it is no surprise that antibodies would increase after taking a third dose. “Antibody response is not the only measure of immune protection,” said Dr. Leana S. Wen, a former health commissioner for Baltimore. “There have been multiple studies that suggest these vaccines also stimulate B cell and T cell immunity, so even if there isn’t as much antibody, that doesn’t mean someone isn’t protected.” In Israel, the government agreed to provide Pfizer with data on its vaccine recipients, and Pfizer has been matching the Israeli data with its own laboratory tests on antibody responses. Some people familiar with the data say that taken together, the two data sets indicate that immunity is waning among the vaccinated after roughly six to eight months, leading to a growing number of breakthrough infections. The attendees at Monday’s session amounted to a who’s who of government doctors: Fauci; Dr. Rochelle Walensky, the director of the CDC; Dr. Francis Collins, the director of the National Institutes of Health; Dr. Vivek Murthy, the surgeon general; Dr. Rachel Levine, the assistant secretary for health; Dr. Janet Woodcock, the acting FDA commissioner; Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research; and Dr. David Kessler, a former FDA commissioner who is heading the Biden administration’s vaccine distribution effort, among others. Del Rio of Emory University complained about Monday’s meeting being conducted in private instead of Pfizer presenting its data publicly to the CDC’s advisory committee on vaccine practices, which will ultimately recommend whether booster shots are necessary. Slightly more than two-thirds of American adults — 67.7% — have had at least one COVID-19 shot, according to the CDC. That figure falls short of the Biden administration’s goals; the president had hoped to have 70% of adults at least partially vaccinated by July 4. Still, the national vaccination campaign has made clear that the vaccine succeeds at preventing disease, and studies suggest that vaccines remain effective against the delta variant. Outbreaks are occurring in areas with low rates of vaccination, and the national caseload has ticked up recently; according to a New York Times database. World Health Organization officials emphasized Monday the importance of prioritizing global vaccine production and distribution over the development of boosters in light of the stark gaps among countries’ vaccination programs. “It’s not to say one or the other; it’s putting things in a crisis in order,” said Dr. Michael Ryan, executive director of the organization’s health emergencies program, in reference to addressing what the organization calls a two-tier pandemic.

US officials press Pfizer for more evidence of need for booster shot