FDA committee will vote unanimously, saying the benefits of J&J COVID-19 vaccine outweigh the risks

Shares of Johnson & Johnson JNJ,
-2.64%
they rose 1.3% in after-hours trading on Friday after the Food and Drug Administration’s advisory committee voted 22-0 for the regulator authorizing the company’s COVID-19 vaccine candidate. The FDA does not have to follow the committee’s advice but they often do. The single-dose vaccine had an overall efficacy rate of approximately 66% in a Phase 3 clinical trial, and the U.S. arm of trial showed an efficacy of approximately 72% and 85% when defending against severe disease. or acute infection. The most common adverse events were pain at the injection site and fatigue. The trial took place in the United States, South Africa, and several countries in Central and South America. If the FDA moves forward with approving the experimental vaccine, this will be the third COVID-19 vaccine to be available in the U.S. – and the first to require only one dose. Both MRNA Moderna Inc.
+ 4.33%
and BioNTech SE BNTX,
-2.94%
and PFE at Pfizer Inc.
-0.98%
Vaccines, which were separately approved in December, need to be dosed in two doses several weeks apart. J&J stock has gained 10.7% over the past 12 months, and the S&P 500 SPX more broadly,
-0.48%
up 22.4%

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