The Food and Drug Administration (FDA) has granted authorization for Novavax’s updated COVID-19 vaccine, offering Americans another option for their immunization. Novavax’s vaccine has been modified to target the XBB strains of the virus and is classified as a protein-based vaccine, unlike the mRNA-based vaccines from Moderna and Pfizer. This authorization provides people with a non-mRNA alternative to protect themselves against COVID-19, which has become the fourth leading cause of death in the United States. The FDA’s approval is the final major regulatory hurdle before Novavax’s vaccine can be distributed.
According to the Centers for Disease Control and Prevention (CDC), descendants of the XBB variant continue to be the primary strains of the coronavirus circulating nationwide. The FDA’s authorization not only offers an additional vaccine option that meets safety and effectiveness standards but also allows previously vaccinated Americans to receive the protein-based Novavax vaccine. Novavax has positioned its vaccine as a traditional alternative to those from Pfizer and Moderna and was previously authorized only as a first booster dose for individuals who couldn’t or wouldn’t take an mRNA vaccine. The company is prepared to ship millions of doses in the coming days.
Novavax’s vaccine authorization was granted later than expected, as the company initially anticipated being in the U.S. market by September. The reasons for the delayed approval are unclear, and the FDA has not provided a comment regarding this matter. One possible explanation may be the timing of the applications, with Moderna and Pfizer submitting their requests earlier. Novavax worked closely with the FDA to ensure that a protein-based vaccine was available for use this fall, despite the longer development process required for non-mRNA vaccines. It should be noted that the FDA’s selection of the variant to target in the updated COVID vaccines was made in June, allowing sufficient time for approval and manufacturing.
