FDA Endorses Johnson & Johnson Single-Shot Covid-19 Vaccine
The FDA has officially cleared the way for a third Coronavirus vaccine in the U.S.
A third vaccine to protect against Covid-19 could be entering the marketplace after the Food and Drug Administration endorsed Johnson & Johnson’s single-shot vaccine for emergency use on February 24.
The FDA staff said the data from the Johnson & Johnson clinical trials was “consistent with the recommendation set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”
Johnson & Johnson submitted its Covid-19 vaccine data to the FDA on Feb. 4. The vaccine’s level of protection varied by region, with the shot demonstrating 66 percent effectiveness overall, 72 percent in the United States, 66 percent in Latin American and 57 percent in South Africa (where the B.1.351 variant is rapidly spreading).
The company said the vaccine prevented 100 percent of hospitalizations and deaths. As of Feb. 5, there were seven Covid-19 deaths in the study in the placebo group and no Covid-19 related deaths in the vaccine group, according to the FDA.
The FDA staff report, where the Johnson & Johnson vaccination was endorsed, is meant to brief the FDA’s Vaccines and Related Biological Product Advisory Committee, which will meet Friday to review J&J’s request for emergency use authorization.
During similar requests by Pfizer and Moderna, the agency authorized those companies’ vaccinations one day after the committee outside medical advisors backed emergency use authorization. The committee is expected to recommend Johnson & Johnson’s vaccine.