FDA Authorizes Novavax’s Updated COVID-19 Vaccine as Third Option for Americans
On Tuesday, the Food and Drug Administration (FDA) announced its authorization of Novavax’s updated COVID-19 vaccine, providing Americans aged 12 and older with a new option for vaccination this fall and winter. Novavax’s updated vaccine has been redesigned to target the XBB strains of the virus, similar to the revised formulations of Moderna and Pfizer vaccines that were approved last month. While Moderna and Pfizer vaccines are based on mRNA technology, Novavax takes a different approach.
Novavax’s CEO, John Jacobs, expressed his excitement about the authorization, stating that it offers people the choice of a protein-based, non-mRNA option to protect themselves against COVID-19. He also emphasized the significance of this choice, as COVID-19 is now the fourth leading cause of death in the United States.
According to the Centers for Disease Control and Prevention (CDC), closely related descendants of the XBB variant remain the dominant strains of coronavirus circulating nationwide. The FDA authorization is the final major regulatory hurdle before Novavax’s new shots can be rolled out. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, commented that the authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness, and manufacturing quality required for emergency use authorization.
The CDC officials confirmed during their meeting last month that they would not need to reconvene to expand recommendations to include Novavax. This authorization also means that many previously vaccinated Americans will now be eligible to receive the protein-based Novavax vaccine, which the company has promoted as a “traditional” alternative to Pfizer and Moderna vaccines. Previously, Novavax was only authorized as a first booster dose for individuals unwilling or unable to receive an mRNA shot.
Novavax has stated that it already has “millions of doses” of its vaccine in the U.S., which will be shipped out in the coming days once the FDA approves each batch. The company has planned for the doses to be available at thousands of locations, including national chain drug stores and doctors’ offices. Novavax spokesperson assured that once batches are released, they will be immediately shipped and made ready for administration. The vaccine will also be available through the federal Bridge Access and Vaccines for Children program in the near future. However, authorization for younger children is not expected until next year.
Novavax’s vaccine authorization was delayed compared to the initial timeline set by the company. Novavax executives had previously aimed to be in the U.S. market “by September.” The reasons behind the delay are unclear, and the FDA spokesperson, Cherie Duvall-Jones, redirected any further questions to Novavax. Novavax acknowledged that they worked closely with the FDA on this Emergency Use Authorization (EUA) to ensure a protein-based option was part of the fall vaccine offering. The delay in authorization could be due to the timing of applications, as Moderna and Pfizer submitted their applications to the FDA earlier than Novavax. Furthermore, the FDA waited until June to determine the specific variant that updated COVID vaccines should target, in order to increase the chances of a good match with the circulating strains during the fall and winter. It is worth noting that non-mRNA vaccines, like Novavax’s, take longer to produce.
In comparison, selections for the strains used in other traditional protein-based vaccines, such as those for the annual flu shot, are made in March to allow ample time for approval and manufacturing.
With the authorization of Novavax’s updated COVID-19 vaccine, Americans now have another option to protect themselves against the virus. The availability of a protein-based non-mRNA vaccine provides individuals with a choice in vaccination methods and aims to contribute to reducing the spread of COVID-19, which continues to impact communities across the nation.
Source: CBS News [https://www.cbsnews.com/news/novavax-covid-vaccine-authorized-fda/]