J&J Closing in on Emergency Authorization of COVID-19 Vaccine
- February 26, 2021
Johnson & Johnson’s (J&J’s) COVID-19 vaccine candidate passed a critical milestone after the Food and Drug Administration (FDA) confirmed February 23 that data on its safety and efficacy met the requirements for an emergency use authorization (EUA).
The FDA released the briefing document in advance of an independent advisory panel meeting scheduled on February 26 to consider whether to recommend issuing an EUA. In the document, the FDA outlined its confirmation of results from a late-stage clinical trial of roughly 40,000 participants, which found the single-dose vaccine was 66.9% effective across all geographic areas at least 14 days after vaccination and 66.1% effective at least 28 days after vaccination.
FDA said the data submitted to date for the vaccine “is consistent with the recommendations” issued in October 2020 for granting an EUA. “As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the briefing document said.
FDA also noted “a favorable safety profile for the vaccine with no specific safety concerns identified that would preclude issuance of an EUA.” The most common adverse reactions associated with the vaccine were injection site pain (48.6%), headache (38.9%), fatigue (38.2%), and myalgia (33.2%). These adverse reactions were predominantly mild and moderate, FDA said.
In December 2020, the FDA issued EUAs to Pfizer Inc. and Moderna Inc. for their vaccines. Unlike the single-dose J&J vaccines, both the Pfizer and Moderna vaccines require two doses spaced about three to four weeks apart.