The U.S. Food and Drug Administration’s staff endorsed Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine for emergency use, a critical step in bringing a third shot to the American marketplace.
The staff report 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.
During similar requests by Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA), the agency authorized those companies’ vaccinations one day after the committee of outside medical advisors backed emergency use authorization. The committee is expected to recommend J&J’s vaccine. The FDA doesn’t have to follow the committee’s recommendation, but it often does.
J&J submitted its COVID vaccine data to the FDA on Feb. 4. The vaccine’s level of protection varied by region, J&J said, with the shot demonstrating 66% effectiveness overall, 72% in the United States, 66% in Latin America and 57% in South Africa, where the B.1.351 variant is rapidly spreading. The company said the vaccine prevented 100% of hospitalizations and deaths.
The news comes as the Biden administration works to ramp up the supply of doses after states complained that demand for the shots was rapidly outpacing supply. Roughly 44.1 million out of some 331 million Americans have received at least their first dose of Pfizer’s and Moderna’s two-dose vaccines, according to data compiled by the Centers for Disease Control and Prevention. More than 19 million have already received their second shot.
JNJ shares gained $1.20 to $161.64.
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