FDA committee votes unanimously, says benefits of J&J’s COVID-19 vaccine outweigh the risks


Shares of Johnson & Johnson
were up 1.3% in after-hours trading on Friday after a Food and Drug Administration advisory committee vote 22-0 in favor of the regulator authorizing the company’s COVID-19 vaccine candidate. The FDA is not required to follow the advice of the committee but often does. The single-dose vaccine had an overall efficacy rate of about 66% in the Phase 3 clinical trial, and the U.S. arm of the trial showed an efficacy rate of about 72% and of 85% when protecting against severe or critical disease. The most common adverse events were pain at the injection site and fatigue. The trial was conducted in the U.S., South Africa, and several Central and South American countries. If the FDA moves forward with authorizing the experimental vaccine, it will be the third COVID-19 vaccine to be available in the U.S. – and the first to require only one dose. Both the Moderna Inc.
and BioNTech SE
and Pfizer Inc.’s
vaccines, which were separately authorized in December, require two doses spaced several weeks apart. J&J’s stock has gained 10.7% over the past 12 months, while the broader S&P 500
is up 22.4%


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