FDA Grants Emergency Use Authorization to Novavax’s COVID-19 Vaccine

The Food and Drug Administration (FDA) has granted emergency use authorization to Novavax’s COVID-19 vaccine, adding to the arsenal of immunizations effective against the circulating strain of the virus.

Unlike the mRNA vaccines that have become commonplace, Novavax’s vaccine is a more traditional protein-based shot. The FDA has authorized its use for individuals aged 12 and older, with previously vaccinated individuals eligible for one dose and those not yet immunized eligible for two.

FDA Grants Emergency Use Authorization to Novavax's COVID-19 Vaccine

According to Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, this authorization provides an additional COVID-19 vaccine option that meets the FDA’s safety, effectiveness, and manufacturing quality standards.

Marks also encouraged eligible individuals to consider receiving an updated COVID-19 vaccine to provide better protection against the currently circulating variants as we move into the fall season and transition into the new year.

The authorization of Novavax’s vaccine comes shortly after the Centers for Disease Control and Prevention (CDC) approved the updated mRNA vaccines from Pfizer and Moderna. All three shots are designed to target the XBB.1.5 omicron subvariant, which, although no longer the predominant mutation in the U.S., is closely related to the current dominant EG.5 strain, accounting for approximately 30 percent of cases, according to the CDC.

Novavax expects doses of its vaccine to be available in thousands of locations across the U.S., including pharmacies, physician offices, public health clinics, and government entities. The company’s CEO, John Jacobs, stated that people should be able to get the updated shot at significant pharmacies, physicians’ offices, clinics, and various government entities within the coming days.

FDA Grants Emergency Use Authorization to Novavax's COVID-19 Vaccine

However, this year’s fall vaccine campaign against COVID-19, the first to have a commercialized approach without significant federal government subsidies, has faced some early challenges. Some insured patients have had to pay out-of-pocket, and many locations are still waiting to receive vaccine supplies.

Major insurers have reassured the Biden administration that the shots will be covered and are working to resolve the early issues.

According to the Department of Health and Human Services, approximately 2 million people have been vaccinated. A recent survey indicated that about half of adults plan to get the updated COVID-19 shots, while most parents said they wouldn’t vaccinate their children.

FDA Grants Emergency Use Authorization to Novavax's COVID-19 Vaccine

As the rollout of Novavax’s vaccine begins, it will add another layer of protection against COVID-19, increasing the options available to individuals seeking immunization. With the authorization of this additional vaccine, efforts to curb the spread of the virus and protect vulnerable populations can continue to advance.