The Food and Drug Administration (FDA) has granted authorization to Novavax’s updated COVID-19 vaccine, providing Americans aged 12 and older with a third option for vaccination this fall and winter. The revamped vaccine focuses on targeting the XBB strains of the virus, similar to the formulations by Moderna and Pfizer. While the latter vaccines are based on mRNA technology, Novavax follows a different approach. The authorization offers individuals the opportunity to choose a protein-based, non-mRNA alternative to protect against COVID-19. Novavax CEO John Jacobs emphasized that the authorization is crucial, as COVID-19 has become the fourth leading cause of death in the U.S.
The FDA’s authorization represents the final regulatory obstacle before Novavax’s new shots can be distributed. Descendants of the XBB variant remain the dominant strains of the coronavirus in circulation nationwide, according to the Centers for Disease Control and Prevention (CDC). The FDA’s approval adds a new vaccine option that meets the necessary standards for safety, effectiveness, and manufacturing quality. Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, expressed the significance of this development. The FDA’s Advisory Committee on Immunization Practices confirmed that they would not need to convene again to expand recommendations to include Novavax.
Novavax’s protein-based vaccine is presented as a traditional alternative to mRNA vaccines like Pfizer and Moderna. Previously, Novavax was only authorized as a primary booster dose for people unable or unwilling to receive an mRNA vaccine. The company has already prepared “millions of doses” of its vaccine for shipment in the U.S., with deliveries expected in the coming days. The vaccines will be available at various locations, including national chain drug stores and doctors’ offices. Novavax aims to have its product readily available for administration as soon as batches are released. The company also plans to provide shots through federal programs, such as the Bridge Access and Vaccines for Children program. However, authorization for younger children is not expected until next year.
The authorization of Novavax’s COVID-19 vaccine has faced delays compared to Pfizer and Moderna. The vaccinemaker initially planned to enter the U.S. market by September, making the reasons for the FDA’s delayed approval unclear. The authorization process relied on the company’s submission to the FDA. Novavax worked closely with the agency to ensure that a protein-based option was included in the fall vaccine offering. One probable explanation for the delay is the timing of the applications. Moderna submitted their applications in March and July, while Pfizer submitted theirs in February and June. Novavax only declared in August that it had begun its FDA submission. This timing limited Novavax’s ability to update their vaccine swiftly for the fall season. While mRNA vaccines typically take longer to produce, strains for traditional protein-based vaccines, such as those used for the yearly flu shot, are selected in March to allow sufficient time for approval and manufacturing.
