FDA panel discusses the booster of Pfizer’s Covid vaccine

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Covid-19 vaccine update

Consultants from the U.S. Food and Drug Administration have begun to debate whether to recommend authorizing Pfizer’s application to provide a broad booster dose of its Covid-19 vaccine.

Members of the Regulatory Vaccine Advisory Committee are expected to vote on whether to approve the third dose of BioNTech/Pfizer vaccine at the end of the meeting on Friday. Although the Biden administration has announced plans to launch a booster program next week, some health officials have postponed it.

Marion Gruber, director of the FDA’s Office of Vaccine Review, is one of two senior officials approved. Publicly opposed the Biden administration’s boost plan, Believes that there is not enough data to show that the effectiveness of the two vaccine doses will diminish over time. Gruber will retire from the FDA next month, and allies expressed her dissatisfaction with the way other parts of the Biden administration have weakened regulators.

At the beginning of the meeting on Friday, Gruber emphasized the high standards of the proposed approval. “People expect to prove the effectiveness of additional doses based on adequate and well-controlled clinical trials,” she said.

Pfizer told the committee that boosters are needed to maintain the effectiveness of the vaccine to ensure that there will be no new wave of serious diseases in the United States in the next few months.

William Gruber, senior vice president of clinical research and development of Pfizer vaccines, told the committee: “Over time, the protective effect of the vaccine against Covid-19 has diminished significantly, and emerging data shows the protective effect on hospitalization. Is weakening,” he added, “it’s time to restore protection with a safe and effective booster dose… It is now.”

Sara Oliver, a scientist in the Viral Diseases Department of the Centers for Disease Control and Prevention, points out that although protection against infection has declined in recent months, “it is difficult to distinguish between the time-increasing impact since the main series and the delta impact variant.”

Pfizer is seeking to provide a booster of its double-dose messenger RNA injection to people 16 years and older at least six months after receiving the second injection. US regulators can choose to limit the availability of booster doses to 65 years and older, which is much narrower than the plan outlined by the White House a month ago.

Andy Slavitt, a former Covid adviser to US President Joe Biden, told the Financial Times: “The CDC may decide that we recommend that people over 65 use this Drugs, but it’s up to the patient to discuss with the doctor whether to receive a booster dose.”

If the committee recommends approval of the application, the FDA may make a final approval within a few days. Once the CDC has issued guidelines on who should qualify, Americans should be able to start receiving booster shots next week.

Earlier this week, both Pfizer and Moderna released data showing that the effectiveness of their mRNA vaccine can be Decline in a few months After the second shot.

Data from Israel It shows that about 10 days after the start of the strengthening plan, severe Covid cases began to drop sharply. The country’s data show that from early July to August, the number of Covid cases there increased by more than 10 times, with 60% of the cases being fully vaccinated people.

Sharon Elroy-Preiss, Director of Public Health Services of the Israeli Ministry of Health, told the expert group: “If we do not start the booster dose at the end of July, we will reach Israel’s hospital capacity and may Exceed it.” On Friday.

The FDA has authorized the injection of mRNA vaccines to people with weakened immune systems. But the idea of ​​allowing more extensive injections is controversial, both because of the limited data available on the long-term effectiveness of the vaccine, and because many countries are still struggling to ensure initial supplies.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, supports strengthening the widespread distribution of injections. He told the committee on Friday that they should “focus on the science related to the application being considered today, not on operational issues related to boosting activities or issues related to global vaccine equity.”

In a report released on Wednesday, FDA staff stated that the data is still inconclusive regarding whether the vaccine’s ability to prevent symptomatic infections will decrease significantly over time. Signs of friction.

Others believe that US regulators should act quickly to contain the recent rise in coronavirus cases.

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

In an open letter published before the FDA meeting on Thursday, Pfizer’s CEO Albert Burla stated that allowing people in rich countries to obtain boosters will not divert supply from those in need: “If the data Show their needs, safety and effectiveness, then they should be approved.”

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