The Food and Drug Administration made an announcement on Tuesday, authorizing Novavax’s updated COVID-19 vaccine. This authorization provides another option for Americans aged 12 and older who are seeking a new vaccine for the fall and winter. The updated shot from Novavax has been specifically designed to target the XBB strains of the virus, similar to the revised formulations from Moderna and Pfizer that were approved last month. While the Moderna and Pfizer vaccines use mRNA technology, Novavax takes a different approach.
“By authorizing Novavax today, people now have a protein-based non-MRNA option to protect themselves against COVID-19. This is significant because COVID-19 is currently the fourth leading cause of death in the U.S.,” stated Novavax’s CEO, John Jacobs.
According to the Centers for Disease Control and Prevention, the XBB variant remains the dominant strain of coronavirus nationwide. The authorization from the FDA is the final regulatory hurdle that Novavax’s new shots need to clear before they can be rolled out.
“Today’s authorization offers an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness, and manufacturing quality required for emergency use authorization,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research in a release.
The CDC officials mentioned at their meeting last month that there was no need to reconvene to expand the recommendations to include Novavax. This authorization also allows previously vaccinated Americans to receive the protein-based Novavax vaccine, which the company has positioned as a “traditional” alternative to Pfizer and Moderna. Previously, Novavax was only authorized as a first booster dose for those unwilling or unable to get an mRNA shot.
When will Novavax’s COVID vaccine be available?
Novavax has stated that it has “millions of doses” of its vaccine in the U.S., and these will be shipped “in the coming days” once the FDA approves each batch. The company has also mentioned that the doses will be available at thousands of locations, including national chain drug stores and doctors’ offices. A spokesperson for Novavax said, “Once batches are released, we will immediately ship and are working to have product on shelves and ready for administration immediately.” The federal Bridge Access and Vaccines for Children program will also offer shots from Novavax “in the coming days.” However, the company does not expect authorization for its vaccine for younger children until next year.
Why was Novavax’s COVID vaccine delayed?
Authorization for Novavax’s shots came later than expected. The company had previously announced plans to enter the U.S. market “by September.” The reasons for the delay in the FDA’s approval for Novavax, as opposed to Pfizer and Moderna, are unclear. Cherie Duvall-Jones, an FDA spokesperson, stated that the authorization was based on the submission made by the vaccine manufacturer and directed further questions to Novavax. A spokesperson for Novavax said that the company had worked closely with the FDA to ensure a protein-based option as part of the fall vaccine offering. One possible reason for the delay could be the timing of the applications. Moderna submitted applications for their 2023-2024 formula to the FDA in March and July, while Pfizer’s applications were submitted in February and June. Novavax reported in August that it had initiated FDA submission for their shots. Officials had previously acknowledged that Novavax’s shots could take longer to update for this fall. The FDA waited until June to finalize the selection for the variant to be targeted by the updated COVID vaccines, aiming for a better match with what was circulating in the fall and winter. Non-mRNA vaccines, like Novavax’s, take longer to manufacture. In contrast, the strains used in traditional protein-based vaccines for the annual flu shot are selected in March to allow enough time for approval and manufacturing.
Denial of responsibility! Vigour Times is an automatic aggregator of Global media. In each content, the hyperlink to the primary source is specified. All trademarks belong to their rightful owners, and all materials to their authors. For any complaint, please reach us at – [email protected]. We will take necessary action within 24 hours.
