J&J had previously said it would have a first chance to review data from its late-stage trial of 45,000 volunteers in the last week of January or the first week of February, consistent with Fauci’s timeline.
From there, J&J would need one to two weeks to analyze the data and prepare documents for regulators in the U.S. and elsewhere seeking emergency-use authorization, if the data demonstrates the shot’s safety and efficacy, Chief Scientific Officer Paul Stoffels told Bloomberg on Jan. 12.
Stoffels said he expects the vaccine won’t be authorized by the U.S. Food and Drug Administration until March. Once the FDA receives J&J’s submission for emergency use, it must convene a panel of outside experts to review the data and make an independent recommendation. That process can take weeks.
Pfizer Inc. and its partner BioNTech SE, for example, submitted such an application for the two-dose Covid-19 vaccine regimen on Nov. 20. The FDA then convened a panel of outside experts, known as the Vaccines and Related Biological Products Advisory Committee, on Dec. 10. The Pfizer-BioNTech vaccine was cleared for use on Dec. 11, three weeks after the companies’ submission.
J&J’s progress is being closely watched by infectious-disease experts because its vaccine has the potential to become the first that can protect people after just one shot, making mass-vaccination campaigns easier.
The U.S. has administered 17.2 million doses of the Pfizer-BioNTech and Moderna Inc. vaccines to date, according to Bloomberg’s Vaccine Tracker. It remains short of the Trump administration’s goal of 20 million administered doses before the end of 2020.
(Updates with details starting in fifth paragraph.)