Novavax Covid-19 vaccine wins FDA authorization

The Food and Drug Administration on Wednesday granted emergency use authorization to Novavax’s Covid-19 vaccine, opening up another option for adults who have not received immunization against the virus.

The vaccine, a two-dose series administered three weeks apart, is manufactured using a lab-made spike protein produced in insect cells and an adjuvant obtained from the bark of a tree native to Chile, offering a different and older vaccine technology than is used in the messenger RNA vaccines and Johnson & Johnson shot. It is authorized for people ages 18 and older as a primary series, meaning the shot is intended for the roughly 10 percent of adults who have not yet received a Covid-19 vaccine.

Novavax executives have said they hope the shot will see uptake in individuals who have expressed hesitancy toward other Covid-19 vaccines or are allergic to components of the others' ingredients.

“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 for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf said in a statement.

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

In a trial of more than 26,000 adults in the U.S. and Mexico, two doses of the Novavax Covid vaccine were more than 90 percent effective at preventing symptomatic disease. For adults 65 and older, effectiveness was more than 78 percent. There were no serious side effects or safety concerns, including for the approximately 21,000 adults who were followed for more than two months after their second shot.

In a press release, the FDA noted that it had conducted a thorough analysis of Novavax’s production capacity as part of its decision to authorize the shot.

The shot received strong backing from the Trump-era Operation Warp Speed effort, but faced difficulties with manufacturing throughout its lengthy vaccine development process.

What’s next: The Centers for Disease Control and Prevention will next decide whether it will endorse the vaccine for adults. The agency’s Advisory Committee on Immunization Practices is scheduled to convene on July 19, but an agenda for the meeting has not yet been published.

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 next few weeks, which would support final release of the product.”

If the vaccine garners a favorable recommendation from the CDC, HHS said the protein-based vaccine will be made available at no cost to states, jurisdictions, federal pharmacy partners and federally qualified health centers.

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

Adam Cancryn contributed to this report.