“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards of safety, efficacy, and manufacturing quality needed to support the authorization of the vaccine. emergency use,” FDA Commissioner Robert Califf said in a statement. .
Background: The Novavax vaccine contains a synthetic coronavirus spike protein made from moth cells and compounds that stimulate an immune response. This formulation is similar to older vaccines.
In a trial of more than 26,000 adults in the US and Mexico, two doses of the Novavax Covid vaccine were more than 90 percent effective in preventing symptomatic disease. For adults 65 and older, the effectiveness was greater than 78 percent. There were no serious side effects or safety concerns, even for the approximately 21,000 adults who were followed for more than two months after the second injection.
In a press release, the FDA noted that it had conducted a comprehensive analysis of the production capacity of Novavax as part of its decision to authorize the injection.
The shot received strong backing from the Trump-era Operation Warp Speed effort, but faced difficulties with manufacturing throughout its lengthy vaccine development process.
Whats Next: The Centers for Disease Control and Prevention will decide next whether to support the vaccine for adults. The agency’s Advisory Committee on Immunization Practices is scheduled to meet on July 19but an agenda for the meeting has not yet been released.
The Biden administration announced earlier this week that it had purchased 3.2 million doses of the Novavax vaccine. The Department of Health and Human Services said Monday that “Novavax is expected to complete all necessary quality testing in the coming weeks, which would support the final launch of the product.”
If the vaccine earns a favorable recommendation from the CDC, HHS said the protein-based vaccine will be available at no cost to states, jurisdictions, federal pharmaceutical partners and federally qualified health centers.
The FDA said it expects Novavax to continue clinical trials to obtain data to support full approval of the vaccine.
Adam Cancryn contributed to this report.