Novavax Covid-19 Vaccine Receives FDA Clearance

“Today’s approval offers adults in the United States who have not yet received a Covid-19 vaccine another option that meets the FDA’s stringent safety, efficacy and manufacturing quality standards needed to support emergency use approval,” it says. in a statement by FDA Commissioner Robert Califf. .

Background: The Novavax vaccine contains a synthetic coronavirus spike protein made from moth cells and compounds that stimulate an immune response. This formula is similar to older vaccines.

In a study 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 illness. For adults 65 and older, the effectiveness was over 78 percent. There were no serious side effects or safety concerns, including in 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 thorough review of Novavax’s manufacturing facilities as part of its vaccine approval decision.

shot received strong support from Trump’s Operation Warp Speed efforts, but faced difficulties in making throughout the lengthy vaccine development process.

What’s next: The Centers for Disease Control and Prevention will then decide whether the adult vaccine will be approved. Agency Advisory Committee on Immunization Practices scheduled for July 19but the agenda of the meeting has not yet been published.

Earlier this week, the Biden administration announced that it had purchased 3.2 million doses of the Novavax vaccine. The Department of Health and Human Services said on Monday that Novavax “is expected to complete all necessary quality testing in the next few weeks to support final product release.”

If the vaccine receives a positive recommendation from the CDC, HHS said the protein-based vaccine will be available free of charge to states, jurisdictions, federal pharmacy partners and federally qualified medical centers.

The FDA said it expects Novavax to continue clinical trials to obtain data supporting full approval of the vaccine.

Adam Kankrin contributed to this report.