- Johnson & Johnson applied for an emergency use authorization from the FDA for its coronavirus vaccine.
- The company released data last week showing it was about 66% effective in protecting against the virus.
- If J&J’s application is approved, it would be the third Covid-19 vaccine authorized for emergency use in the U.S. behind those developed by Pfizer-BioNTech and Moderna.
Johnson & Johnson applied for an emergency use authorization from the Food and Drug Administration for its coronavirus vaccine after releasing data last week showing it was about 66% effective in protecting against the virus.
If J&J’s application is approved, it would be the third Covid-19 vaccine authorized for emergency use in the U.S. behind those developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was authorized by the FDA on Dec. 11, and Moderna’s was authorized a week later.
“Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” J&J’s chief scientific officer, Dr. Paul Stoffels, said in a statement.
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” he said. “With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 26 to discuss the emergency use authorization.
“A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” acting FDA Commissioner Janet Woodcock said in a statement. “The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines.”
U.S. officials and Wall Street analysts are eagerly anticipating the authorization of J&J’s vaccine, which could happen as early as this month. President Joe Biden is trying to pick up the pace of vaccinations in the U.S. and experts say his administration will need an array of drugs and vaccines to defeat the virus, which has killed more than 450,000 Americans over the last year, according to data compiled by Johns Hopkins University.