Wednesday, January 20, 2021

FDA panel debates authorization of Pfizer / BioNTech vaccine

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The United States took a step closer to a decision on the Pfizer / BioNTech Covid-19 vaccine on Thursday, as a panel of experts began deliberations on whether it would recommend that the vaccine receive a emergency clearance.

After a full-day meeting of scientists on the Vaccines and Related Biologics Advisory Committee, the panel will vote on a single question: whether or not the benefits of the Pfizer / BioNTech vaccine outweigh its risks for a vaccine. use in individuals 16 years of age and over.

It will also consider whether there are any gaps in the evidence provided by Pfizer / BioNTech and if and when the placebo group in the trial should be vaccinated.

Ahead of the meeting, Stephen Hahn, the head of the U.S. Food and Drug Administration, who will make the final decision on whether to release the vaccine for public use, vowed to make a decision soon after the committee’s recommendation. .

Dr Hahn said in a statement, “In this time of great urgency, FDA staff feel a responsibility to move forward through the review process as quickly as possible.

“However, they know they must fulfill their mandate to protect public health and ensure that any licensed vaccine meets our rigorous standards for safety and efficacy that Americans have come to expect.”

Separately, he told NBC News, “Our initial assessment is that this is a vaccine that meets our criteria. . . But we want to hear from the vaccine advisory committee.

The vaccine has so far been authorized in the UK, Canada, Bahrain and Saudi Arabia.

The FDA said earlier this week that test data confirmed Pfizer’s claim that his vaccine was effective on average 95% and started to work about 10 days after the first of the two doses was given.

Based on this information, the UK last week became the first country to give the green light to start vaccinations. Margaret Keenan, 90, and William Shakespeare, 81, became the the first people receive injections outside of the testing process.

At the same time, the New England Journal of Medicine published the results of Pfizer / BioNTech’s Phase 3 trial data, the first time they were published in a peer-reviewed journal.

He confirmed that the vaccine had a similar rate of effectiveness across all age groups, race, ethnicity, weight and underlying chronic diseases. The authors concluded that the safety profile – studied for an average of two months after vaccination – was similar to that of other viral vaccines.

The document said there was one case of severe Covid-19 in the vaccination group, compared to nine in the placebo group. The committee will likely want to discuss the reasons why a participant became seriously ill, as well as a some cases of allergic reactions seen in the UK this week.

In a separate editorial in the same journal, Eric Rubin, an immunologist at Harvard University and a member of the FDA advisory board, called the results a “triumph.”

He wrote: “Most vaccines have taken decades to develop, but this one is likely to move from conception to full scale implementation within a year.”

The meeting comes as the toll of the pandemic in the United States continues to worsen, with infections and hospitalizations reaching record levels. On Wednesday, the country recorded more than 3,000 coronavirus deaths For the very first time.

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