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The US Food and Drug Administration (FDA) vaccine committee has given the green light to the the Pfizer/BioNTech vaccine, meaning approval may happen in a matter of days.
The US Food and Drug Administration vaccine advisory committee has given their approval for the Pfizer/BioNTech COVID-19 messenger RNA vaccine candidate to continue on to approval through emergency use authorization.1 The vaccine is would be approved for use in people aged 16 years and older. The vaccine is currently in trial to judge its efficacy in children aged 12 to 15 years. The vaccine is given in 2 doses of µg30 each, with the doses administered 21 days apart.
The clinical trial for the vaccine included over 38,000 participants in the United States, Argentina, Brazil, Germany, South Africa, and Turkey. The most common adverse reactions to the vaccine included reaction at the injection site, fatigue, headaches, muscle pain, chills, joint pain, and fever. A summary of the vaccine’s efficacy showed it was 95%, 7 days after receiving the second dose (95% CI 90.3; 97.6) in people who had no evidence of a COVID-19 infection. In a group with or without prior infection, efficacy was >94% and were robust across demographic subgroups. Efficacy against severe COVID-19 that occurred after the first dose was 88.9% (95% CI 20.1, 99.7) with an estimated efficacy of 75.0% (95% CI -152.6, 99.5) against severe COVID-19 7 days after receiving dose 2.
Common adverse events included reaction at injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and fever (14.2%). Serious adverse events were rare with just 0.6% of the vaccine group and 0.5% of the placebo group reporting them. It’s expected that health care workers and the groups most at risk of the disease, such as adults who live in nursing homes will be in the first group to receive the vaccine, which should start being administered within 48 hours of its approval.
1. Food Drug Administration. Vaccines and related biological products advisory committee meeting. Fda.gov. Published December 10, 2020. Accessed December 10, 2020. https://www.fda.gov/media/144245/download.