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Its use is prohibited from 16 years of age …
The United States Food and Drug Administration (FDA) advisory committee recommended approval of the BNT162b2 COVID-19 mRNA vaccine from Pfizer and Bioentech.
Foreign media, including Reuters, reported on the 10th (local time) that a committee of outside experts from the US Food and Drug Administration overwhelmingly approved Pfizer’s emergency use of the COVID-19 vaccine. .
Consequently, the FDA is expected to approve the urgent use of the vaccine within a few days. Transportation and vaccination of the vaccine in the United States will begin immediately after approval.
At the advisory committee meeting, the results of voting on whether the benefits provided by the vaccine to people 16 years of age or older outweighed the risk were 17 in favor, 4 in favor, and 1 in favor of abstention.
Pfizer has applied for approval of the vaccine for use in two doses in people ages 16 to 85.
Some advisory committee members raised questions about including this in the scope of approval, saying that 16- and 17-year-olds are low risk and lack evidence from clinical trials.
The advisory committee also discussed concerns raised by two serious allergic reactions reported in the UK, where vaccination had already started, and the possibility of their use in pregnant women.
The FDA noted that there was insufficient data to support or refute the use of vaccines in pregnant women and recommended that the decision be made with the advice of a physician.
Documents prepared by the FDA prior to the Advisory Committee meeting did not indicate any new safety or efficacy concerns. The US Food and Drug Administration generally makes decisions based on the advice of the advisory board, but is not required to follow it.
Meanwhile, on the 9th, British health officials advised against giving the vaccine to people who have experienced anaphylaxis, an overreaction of the immune system.
FDA Director Stephen Han said he was carefully reviewing all vaccine data, including allergic reactions, following warnings from British authorities.
He added that the vaccine label will contain detailed information on who is advised to get vaccinated and who is not.
Pfizer and Bioentech’s COVID-19 vaccine showed a 95% preventive effect in clinical trials. According to the FDA documents, it was found that there were cases in which the preventive effect appeared after the first vaccination.
Detailed results of the clinical trial were published in the international journal The New England Journal of Medicine.
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