The Food and Drug Administration’s staff endorsed Johnson & Johnson’s Covid-19 vaccine for emergency use, a critical step in bringing a third shot to the U.S. marketplace.
The staff report released Wednesday is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which will meet Friday to review J&J’s request for emergency use authorization.
The FDA staff said it determined that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”
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BREAKING: FDA scientists confirm safety & efficacy of one-dose Johnson & Johnson #covid19 vaccine.
* 86% effective against severe disease in the U.S. & 82% in South Africa (with predominant B.1.351 variant)
* Consistent across ages
* Possible reduction of asymptomatic infection
— Leana Wen, M.D. (@DrLeanaWen) February 24, 2021