FDA panel vote on Covid boosters puts Biden's plan backwards

Pressure from the Biden administration to make Covid-19 boosters available to most fully vaccinated adults has so far been blocked by a ...

Pressure from the Biden administration to make Covid-19 boosters available to most fully vaccinated adults has so far been blocked by a recommendation from a Food and Drug Administration advisory group that Pfizer boosters be made available than to people 65 years of age and over and those at high risk of severe Covid.

However, the heated debate over the need for the shots more generally remains unresolved.

Friday’s expert panel voted overwhelmingly not to recommend boosters for over 16s after a tense one-day debate that highlighted divisions within the agency and administration.

The vote was a blow to President Biden, stepping up criticism of his efforts to bolster the immunity of Americans already vaccinated at a time when most people in poor countries haven’t even had the first few doses. The FDA and the Centers for Disease Control and Prevention third injections authorized for certain immunocompromised people over a month ago, on the grounds that the extra dose would simply increase their protection to the level other people achieve with two injections.

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

The panel’s final recommendations left some leeway for the White House to assert that the core of its recall strategy remained intact. Depending on the definition of “high risk,” tens of millions of Americans could potentially be considered eligible for additional injections of the Pfizer vaccine. And a small but growing number of people have stopped waiting for federal clearance and are find ways to get booster shots.

Before the panel meets on Friday, the Centers for Disaster Control and Prevention published data indicating that, for some people, the level of protection against Covid hospitalizations offered by the Pfizer-BioNTech vaccine has dropped significantly four months after full inoculation.

The CDC study supported others who suggest that the Pfizer vaccine may offer less protection against hospitalization over time. The data available is far from unanimous, although so far it suggests that only the elderly will need boosters. Participants in the CDC study were older, and it was not clear whether the same decline in vaccine effectiveness occurred in young people who were vaccinated.

Other studies have shown that Pfizer’s effectiveness against hospitalization has remained above 90 percent, despite the rapid spread of the Delta variant and the passage of time. Pfizer said data from Israel suggests a decrease in effectiveness against serious illnesses, although it appears that Israel and the United States define “critical illness” differently.

The debate unfolds as the Delta variant continues to ravage the least vaccinated areas of the country. New coronavirus cases and Covid hospitalizations across the United States have started to show signs of decline, although they remain much higher than they were at the start of the summer. And the average daily death toll 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 administer about 775,000 doses per day on average, according to federal data, a fraction of the April peak but still more than 250,000 more than the July low. About 54 percent of Americans are fully immunized, according to a New York Times Database, the second lowest proportion among Group of 7 rich nations – but Japan’s now aggressive vaccination campaign will likely leave the United States last in the G-7 shortly.

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

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Newsrust - US Top News: FDA panel vote on Covid boosters puts Biden's plan backwards
FDA panel vote on Covid boosters puts Biden's plan backwards
Newsrust - US Top News
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