Sunday, October 17, 2021

FDA Panel Discusses Drivers of Pfizer’s Covid Vaccine

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Covid-19 vaccine updates

Advisers to the US Food and Drug Administration have begun debating whether to recommend authorization of Pfizer’s application to offer generalized booster doses of its Covid-19 vaccine.

Members of the regulator’s vaccine advisory committee are expected to vote at the end of Friday’s meeting on approval of a third dose of the BioNTech / Pfizer vaccine. While the Biden administration has already announced plans to launch a booster program next week, some health officials have rejected it.

Marion Gruber, director of the FDA’s office of vaccine review, is one of two senior officials who have spoken out against the plan, arguing that there is insufficient data to show that the effectiveness of two doses of vaccines decreases with the weather. Gruber is retiring from the FDA next month, and her allies have said she’s unhappy about the way the regulator has been undermined by other parts of the Biden administration.

Speaking at the start of Friday’s meeting, Gruber emphasized the high bar in recommending approval. “There is an expectation that the demonstration of the efficacy of the additional dose will be based on adequate and well-controlled clinical trials,” he said.

“The data available to support the efficacy of a booster dose, specifically against currently circulating Sars-Cov-2 variants, and the benefit of the booster dose must be considered in relation to the benefit already provided by previous vaccines with the primary series “.

Sara Oliver, a scientist in the division of viral diseases at the Centers for Disease Control and Prevention, said: “Protection against infection. . .[is]lower in recent months. However, it is difficult to distinguish the effects of the increase in time from the primary series versus the impact of the Delta variant. “

Pfizer is seeking permission to offer people over 16 years of age a two-dose messenger RNA injection booster at least six months after receiving the second injection. US regulators could choose to limit the availability of booster doses to only those 65 and older, a significantly narrower plan than the one outlined by the White House a month ago.

Andy Slavitt, former Covid adviser to US President Joe Biden, told the Financial Times: “The CDC may decide to say that we recommend this for those over 65, but it is up to patients to discuss with their doctors whether they should receive a booster dose. . . “

If the committee recommends approving the application, the FDA will likely give its final approval in a few days. Once the CDC has issued guidelines on who should be eligible, Americans should be able to start receiving booster doses next week.

Earlier this week, Pfizer and Moderna published data suggesting that the effectiveness of their mRNA vaccines may decrease months after a second injection.

Israel data, which will be presented to the advisory panel on Friday, shows that severe Covid cases began to decline dramatically about 10 days after the booster program began.

The FDA has already authorized mRNA vaccine booster injections for people with weakened immune systems. But the idea of ​​allowing booster vaccines more broadly is controversial, both because of the limited data available on the long-term effectiveness of vaccines in the real world, and because many countries are still struggling to secure initial supplies.

In a report released Wednesday, FDA staff said data was inconclusive on whether the vaccine’s ability to stop symptomatic infection declined significantly over time, a sign of internal friction within the regulator over whether boosters are needed. .

“Overall, the data indicates that currently licensed or licensed Covid-19 vaccines in the United States still provide protection against severe Covid-19 illness and death in the United States,” the agency said in a briefing document also released on Thursday. Wednesday.

Others argue that US regulators should act quickly to stop the recent surge in coronavirus cases.

Ali Mokdad, professor of global health at the University of Washington, said: “We need a booster for everyone and move on. Once we have reinforcements, we can donate vaccines. “

In an open letter published Thursday before the FDA meeting, Pfizer CEO Albert Bourla said that allowing people in rich countries to get reinforcements would not divert supplies from those in need.

“If the data shows its need, safety and efficacy, then it should be approved. Otherwise, they should not be approved. However, I believe that the introduction of booster doses should not change the number of doses that each country receives, ”he wrote.

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