F.D.A. Panel Recommends Pfizer Boosters for Those Over 65 or at Risk

The same advisers overwhelmingly recommended against authorizing boosters for people under 65, complicating the Biden administration’s hopes to offer them more broadly.,

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WASHINGTON — A scientific advisory committee to the Food and Drug Administration on Friday recommended booster shots for recipients of the Pfizer-BioNTech coronavirus vaccine who are 65 or older or are at high risk of severe Covid-19, at least six months after the second shot.

Committee members advised that those considered at high risk should include health care workers, emergency responders and others who are exposed to the virus by their jobs.

The move came shortly after the panel overwhelmingly recommended against approving a Pfizer booster for people 16 and older.

The committee voted 16 to 2 against that broader recommendation after an intense daylong public discussion. The initial vote was a resounding rejection of Pfizer’s request for third shots for those 16 and up. The panel then narrowed the group authorized for extra shots to the elderly and advised that high-risk workers also be included. A senior F.D.A. official suggested teachers would be considered part of that group.

The Biden administration had been hoping the F.D.A. and the Centers for Disease Control and Prevention would approve a third shot of the Pfizer vaccine in time to begin rolling out boosters for Pfizer recipients next week.

The committee’s recommendation was more narrow than some federal officials had been hoping, but still left some room for the White House to argue its strategy of offering extra shots to those who were fully vaccinated at least eight months ago remains intact. Biden aides noted that elderly people, including nursing home residents and health care and emergency workers, were among the first to be vaccinated and will remain first in line for the booster shots if the F.D.A. follows the expert panel’s advice.

Although the agency is not obliged to do so, it typically heeds the panel’s recommendations. The agency will likely make a decision by early next week. If cleared, the third shot would be authorized for emergency use.

The vote came after a sharp debate in which many of the panel’s independent experts, including infectious disease doctors and statisticians, challenged whether the data justified extra shots for so much of the population when the vaccines appear to still offer robust protection against severe Covid-19 disease and hospitalization, at least in the United States.

“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health.

The negative vote was the latest in a series of setbacks for President Biden’s booster plan since he first announced it a month ago. Mr. Biden said at the time that he wanted most adults who had gotten a second Pfizer or Moderna vaccine at least eight months ago to start receiving booster shots the week of Sept. 20.

But two weeks after his announcement, leaders of the F.D.A. and the C.D.C. told the White House that it would be impossible to authorize booster shots for recipients of the Moderna vaccine that soon. It is now unclear whether extra injections will be offered to Pfizer recipients, and if so, to how many.

In a remarkable public display of internal dissension, two F.D.A. scientists co-authored a medical journal article earlier this week arguing that there was no credible evidence yet in support of booster shots for the general population. Those officials, who are leaving the agency this fall, joined outside experts and other federal health officials who cast doubt at the meeting on whether Pfizer’s request should be approved.

On the other hand, Dr. Peter Marks, their superior and the official who oversees the F.D.A.’s vaccine division, noted that many well-known vaccines require booster shots and urged the committee to consider the importance of not just of preventing severe disease but of curbing the spread of infection.

After the F.D.A. rules on Pfizer’s request, an advisory committee to the C.D.C. will meet to recommend how exactly the extra doses should be used. Earlier public discussions suggest the C.D.C. committee was also leaning toward tailoring booster shots toward the elderly and others particularly vulnerable to worse outcomes from Covid-19, instead of to all those who received their second injection eight months earlier.

Federal officials argue that even if the C.D.C. adopts that approach, the White House’s original plan will still remain largely intact, because nursing home residents and other elderly people, along with health care and emergency workers, were primarily the groups vaccinated first.

The F.D.A. committee’s vote followed hours of presentations by officials from Pfizer, the C.D.C., the Israeli government and independent experts on the complex array of data they have collected up until now about the waning effectiveness of Pfizer and other vaccines over time.

Dr. Sara Oliver of the C.D.C. presented data showing that vaccines continue to strongly protect against severe forms of Covid-19 in the United States, even in people 75 and older.

Jonathan Sterne, a professor of medical statistics and epidemiology in the United Kingdom, said he had analyzed 76 different studies on the vaccines’ real world effectiveness and found that multiple factors can skew the results, including how many unvaccinated people in a study have natural immunity from prior Covid-19 disease. He also warned against drawing conclusions from short-term results from booster shots; data from Israel, for example, only included a follow-up period of several weeks for older adults.

Understand Vaccine and Mask Mandates in the U.S.

Vaccine rules. On Aug. 23, the Food and Drug Administration granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, paving the way for an increase in mandates in both the public and private sectors. Private companies have been increasingly mandating vaccines for employees. Such mandates are legally allowed and have been upheld in court challenges.Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.Schools. Both California and New York City have introduced vaccine mandates for education staff. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots. Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.New York City. Proof of vaccination is required of workers and customers for indoor dining, gyms, performances and other indoor situations, although enforcement does not begin until Sept. 13. Teachers and other education workers in the city’s vast school system will need to have at least one vaccine dose by Sept. 27, without the option of weekly testing. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.

Israeli experts made a different argument, telling the committee that they believed third Pfizer shots helped dampen a fourth wave of transmission as the Delta variant swept the nation this summer. The Israeli government, which has relied almost entirely on the Pfizer vaccine, began offering booster shots in late July, starting with the elderly.

Dr. Sharon Alroy-Preis, Israel’s head of public health services said the summer’s rise in the number of hospitalized patients who had been fully vaccinated with Pfizer’s vaccine was “scary.” She said 60 percent of severely or critically ill patients and 45 percent of those who died during what she called the fourth surge had received two injections of Pfizer’s vaccine.

After offering boosters to the general population, she said, Israel is now averaging about half as many severe or critically ill patients as anticipated. She said boosters not only helped curb the spread of infection, but “actually saved lives.”

Another Israeli scientist walked the panel through a new study of health records of more than 1.1. million people over age 60. It found that at least 12 days after the booster, the rates of severe disease were nearly twentyfold lower among those who received a third Pfizer shot compared to those who did not.

Dr. William C. Gruber, a senior Pfizer vice president in charge of vaccine development, suggested that if the United States does not follow Israel’s lead, it could potentially face more than five million more infections a year among people who received their second dose 10 months earlier, compared to those who got the second shot five months earlier.

“Israel could portend the U.S. Covid-19 future, and soon,” he said.

He said Pfizer’s data shows a third shot elicits a robust antibody immune response that equals or greatly exceeds the response after the second dose. Data also show, he argued, that breakthrough infections among vaccinated Americans are linked more to the ebbing power of the vaccine over time instead than to the Delta variant.

But committee members, including some government officials, appeared deeply skeptical of the Pfizer’s data and Israel’s analyses. Dr. Philip Krause, one of the F.D.A. vaccine experts who authored the medical journal review, criticized Pfizer’s presentation of data that had not been peer-reviewed or evaluated by the F.D.A., arguing that possible problems in the modeling within could understate the vaccine’s efficacy.

Dr. Oliver, the C.D.C. official, questioned attempts to draw a parallel between the United States and Israel, noting that Israel has only nine million residents and is less diverse than the United States. Notably, she also said that Israel defines a severe case of Covid-19 more broadly than the United States does, which might help explain why Israel reports more serious breakthrough infections among its vaccinated.

Another C.D.C. official, Dr. Amanda Cohn, asked Israeli officials why the spread of the virus there had recently intensified, despite a broad rollout of boosters. Dr. Alroy-Preis said that the Jewish holidays, together with the start of the school year, had contributed to what she suggested would be a temporary surge in cases.

Committee members also said they were concerned about a paucity of safety data in younger recipients of a booster dose, since studies have shown a higher risk of the heart condition myocarditis in young men who received Pfizer-BioNTech’s vaccine. Several of them asked whether it would be better to wait for a booster vaccine designed specifically to fend off the Delta variant of the virus.

Apoorva Mandavilli and Sheryl Gay Stolberg contributed reporting.

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