FDA Panel Discusses Pfizer’s Covid Vaccine Booster

Covid-19 vaccine update

US Food and Drug Administration advisors have begun discussions on whether to recommend approval for Pfizer’s application to provide a wide range of booster immunizations for the Covid-19 vaccine.

Members of the Regulatory Vaccine Advisory Board are expected to vote at the end of Friday’s meeting on whether to approve a third dose of the BioNTech / Pfizer vaccine. The Biden administration has already announced plans to launch a booster program next week, but some health officials are against it.

Marion Gruber, director of the FDA’s Vaccine Review Board, is one of two senior officials. Speaked against the planThe data argue that there is insufficient data to show that the efficacy of the two vaccines diminishes over time. Gruber retired from the FDA next month, and allies said they were dissatisfied with how regulators were weakened by other parts of the Biden administration.

At the beginning of Friday’s meeting, Gruber emphasized high standards for recommending approval. “Demonstration of the efficacy of additional doses is expected to be based on well-managed and well-controlled clinical trials,” she said.

“Available data supporting the effectiveness of booster doses, especially for the currently circulating Sars-Cov-2 variant, and the benefits of booster doses are compared to those already provided by previous vaccinations in the primary series. Should be considered. “

Sarah Oliver, a scientist in the Viral Infections Division of the US Centers for Disease Control and Prevention, said: .. ..[is]It has been low in recent months. However, it is difficult to distinguish between the effects of increasing time since the primary series and the effects of delta variants. “

Pfizer is seeking permission from people over the age of 16 to provide a double-dose messenger RNA jab booster at least 6 months after receiving the second shot. US regulators can choose to limit the availability of booster doses to those in their 65s and above. This is a much narrower plan than the plan outlined by the White House a month ago.

Andy Slavit, a former Covid adviser to US President Joe Biden, told the Financial Times: .. “

If the Commission recommends approval of the application, the FDA may give final approval within a few days. With the CDC issuing guidelines on who is eligible, Americans should be able to start getting booster jabs next week.

Earlier this week, both Pfizer and Moderna released data suggesting the effectiveness of the mRNA vaccine. Decline within a few months After the second shot.

Data from IsraelScheduled to be submitted to the Advisory Board on Friday, it indicates that serious Covid cases began to decline sharply about 10 days after the booster program began.

The FDA has already approved booster shots of the mRNA vaccine for people with weakened immunity. However, boosters are due to both the limited data available on the long-term efficacy of vaccines in the real world and the fact that many countries are still struggling to secure initial supply. The idea of ​​allowing shots more widely is controversial.

In a report released Wednesday, FDA staff said the data on whether the vaccine’s ability to block symptomatic infections declined significantly over time was not conclusive and regulated whether boosters were needed. He said it was a sign of internal friction within the authorities.

“Overall, the data show that the Covid-19 vaccine currently licensed or licensed in the United States still provides protection against severe Covid-19 disease and death in the United States,” officials said Wednesday. Said in a briefing document published in.

Some US regulators argue that action should be taken swiftly to stop the recent increase in cases of coronavirus.

Ali Mokudad, a professor of global health at the University of Washington, said: Once you have a booster, you can donate the vaccine. “

Pfizer CEO Albert Bourla said in an open letter released Thursday prior to the FDA meeting that people in rich countries were allowed to get boosters, but those in need. He said he would not divert supplies.

“If the data indicate their need, safety, and efficacy, they should be approved. If not, they should not be approved. However, the introduction of booster doses is not possible for each country. I believe we shouldn’t change the number of doses we receive, “he writes.

FDA Panel Discusses Pfizer’s Covid Vaccine Booster

Source link FDA Panel Discusses Pfizer’s Covid Vaccine Booster

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