.FDA Panel Recommends Against Approving Pfizer-BioNTech Booster

By Noah Weiland and Sharon LaFraniere, The New York Times

WASHINGTON — A scientific advisory committee to the Food and Drug Administration on Friday overwhelmingly recommended against approving a booster shot of the Pfizer-BioNTech coronavirus vaccine for people 16 and older.

The committee voted 16-3 after holding an intense daylong public discussion on whether booster shots are necessary and, if so, for whom. The Biden administration has been hoping the FDA would approve a third shot of the Pfizer vaccine in time to begin rolling out boosters for Pfizer recipients next week.

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 a broad rollout of extra shots 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 Kurilla, a committee member and official at the National Institutes of Health.

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It was not immediately clear whether a second vote, on whether booster shots should be approved for older people, who are more vulnerable to severe COVID-19, would follow the first.

The recommendation was the latest in a series of setbacks for President Joe Biden’s booster plan since he first announced it a month ago. 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 FDA and the Centers for Disease Control and Prevention 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. Although the FDA is not obliged to follow its advisory committee’s recommendations, it typically does.The agency will likely make a decision by early next week.

In a remarkable public display of internal dissension, two FDA 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 FDA’s vaccine division, noted that many well-known vaccines require booster shots and urged the committee to consider the importance of not just preventing severe disease but of curbing the spread of infection.

After the FDA rules on Pfizer’s request, an advisory committee to the CDC will meet to recommend how exactly the extra doses should be used. Earlier public discussions suggest the CDC committee may be 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.

The FDA committee’s vote followed hours of presentations by officials from Pfizer, the CDC, 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 CDC 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 public health research 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, shows only that a booster can enhance protection for a few weeks in older adults.

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% of severely or critically ill patients and 45% 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 also “actually saved lives.”

Another Israeli scientist walked the panel through a new study of health records of more than 1.1. million people older than 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 Gruber, a Pfizer senior 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 5 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 than to the delta variant.

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

Oliver, the CDC official, questioned attempts to draw a parallel between the United States and Israel, noting that Israel has only 9 million residents and is less heterogenous 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 CDC official, Dr. Amanda Cohn, asked Israeli officials why the spread of the virus there had recently intensified, despite a broad rollout of boosters. 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.

This article originally appeared in The New York Times.


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