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An FDA panel vote treats the Biden administration’s push for universal booster shots as a setback.


The Biden administration’s drive to make Covid-19 booster injections available to most fully vaccinated adults has been hampered for the time being by the recommendation of a Food and Drug Administration advisory panel to make Pfizer boosters available only to people over 65 and people at high risk of severe Covid.

However, the swirling debate over whether the shots are needed wider remains unsettled.

The panel of experts voted by an overwhelming majority on Friday not to recommend boosters for people over 16 after a tense day-long debate that showed divisions within the agency and the administration to the public.

The vote was a blow to President Biden and reinforced criticism for his attempt to boost the immunity of already vaccinated Americans at a time when most residents of poor countries have not even had the first doses. The FDA and the Centers for Disease Control and Prevention approved third injections for some immunocompromised individuals over a month ago, on the grounds that the extra dose would simply boost their protection to the level other people achieve with two injections. .

Some FDA experts said the data from Pfizer and elsewhere still seemed to show that two injections months later protected against serious illness or hospitalization, and that there was not enough evidence that a third injection would stop the spread of infection. Some also criticized a lack of data that an additional injection would be safe for younger people.

The panel’s final recommendations left the White House some room to argue that the core of its booster strategy remained intact. Depending on how “high-risk” is defined, tens of millions of Americans could be eligible for additional injections of the Pfizer vaccine. And a small but growing number of people are no longer waiting for federal clearance and are finding ways to get booster shots.

Before the panel met on Friday, the Centers for Disease Control and Prevention released data indicating that for some people, the level of protection from Covid hospitalizations afforded by the Pfizer-BioNTech vaccine dropped significantly four months after full inoculation.

The CDC study supported some others that suggest that the Pfizer vaccine may offer less protection against hospitalization over time. The available data is far from unanimous, but so far it suggests that only older adults need boosters. Participants in the CDC study were older, and it was unclear whether the same decrease in vaccine effectiveness occurred in younger vaccinated people.

Other studies have shown that the effectiveness of Pfizer against hospitalization has remained above 90 percent, despite the rapid spread of the Delta variant and the passage of time. Pfizer has said data from Israel points to declining effectiveness against serious illness, although it seems that Israel and the United States define “serious illness” differently.

The debate is unfolding as the Delta variant continues to devastate the less vaccinated parts of the country. New cases of coronavirus and Covid hospitalizations in the United States are beginning to show signs of decline, though they remain much higher than earlier in the summer. And the average number of daily deaths has risen since early July, from this year’s low of 175 to nearly 2,000 by the end of this week, according to a New York Times database. About one in 500 Americans has died from the disease.

The pace of vaccinations remains relatively slow. Providers are administering an average of about 775,000 doses per day, according to federal data, a fraction of the April peak, but still more than 250,000 higher than the July low. About 54 percent of Americans are fully vaccinated, according to a New York Times database, the second-lowest of the group of 7 wealthy nations — but Japan’s now-aggressive vaccination campaign is likely to leave the United States at the G -7.

The FDA has the final say on vaccine approval, and while it’s not required to follow the advisory committee’s recommendations, it usually does. The agency is likely to make a decision on boosters early next week.

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