The Food and Drug Administration (FDA) on Tuesday released a detailed analysis of the COVID-19 vaccine from Pfizer, deeming the two-shot immunization safe and effective.
The move comes two days ahead of an FDA meeting of the Vaccines and Related Biological Products Advisory Committee, a group of independent experts set to advise the agency on whether to grant the vaccine emergency use authorization (EUA).
The agency released two separate analyses, one from its own team of scientists and a second from the vaccine’s manufacturers, Pfizer Inc. and German partner BioNTech SE. They conclude that the vaccine “met the prescribed success criteria.” The vaccine, the FDA said, is “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”
“Safety data from approximately 38,000 participants [greater than or equal to] 16 years of age randomized 1:1 to vaccine or placebo with a median of 2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA,” the FDA wrote.
The FDA’s analysis finds “no specific safety concerns identified that would preclude issuance of an EUA.” The analysis found that serious reactions were rare but side effects were common, including reactions at the site of injection, headaches and fatigue.
The analysis also confirmed that the vaccine is 95% effective assessed two doses, 21 days apart, but also said it was 82% effective to prevent COVID-19 after a single dose.
The vaccine is already in use: A 90-year-old woman in Britain on Tuesday became the first person in the world to receive the Pfizer vaccine.
Pfizer’s is one of three vaccines currently in the works. Biotech firm Moderna on Nov. 30 moved to win emergency use authorization from the FDA for its experimental COVID-19 vaccine.
Moderna’s request came after Pfizer filed their application on Nov. 20. Moderna said its data showed their vaccine was 94.1% effective in its late-stage clinical trial. The Moderna vaccine was developed in conjunction with the Trump administration’s Operation Warp Speed.
A key advantage of Moderna’s vaccine is that it does not need sub-zero storage like Pfizer’s, which needs to be stored at -94 degrees.
A third vaccine is also in the pipeline. AstraZeneca and Oxford University on Nov. 23 said their jointly created COVID-19 vaccine has proven to be up to 90% effective, and the makers claim it will be easier to distribute.
The CDC’s Advisory Committee on Immunization Practices (ACIP) on Dec. 2 voted to direct that healthcare workers and residents of long-term care facilities will be the first to get the shots in the initial rollout — once federal regulators authorize use of a vaccine. The recommendation was approved by CDC Director Robert Redfield, but governors will eventually have the final say on who gets the vaccine first.
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