The U.S. Food and Drug Administration (FDA) said it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech, a part of Johnson and Johnson, according to a news release from the agency.
The FDA said it plans to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting. After the meeting, the advisory committee will submit its recommendations about the EUA request to the FDA.
Janssen Biotech said the EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. It also said it expects to have product available to ship immediately following authorization.
The Janssen vaccine, which can be stored in most standard refrigerators at temperatures of 36°F–46°F, leverages the Company’s AdVac vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.
Meanwhile, Novavax, which is developing another COVID-19 vaccine candidate, said it has initiated a rolling submission process with multiple regulatory agencies, including the FDA, to expediate the review process. The ongoing reviews will continue while the company completes its Phase 3 trials in the United Kingdom and United States and continue after initial authorization for emergency use granted under each country’s specific regulations.
