food and drug administration announced On Tuesday, the company authorized Novavax’s latest coronavirus vaccine, adding a third option for Americans 12 and older seeking a new shot this fall and winter.
Novavax’s updated shot has been redesigned to target the XBB strain of the virus. Moderna and Pfizer’s revised formulations it is approved last month. Both the Moderna and Pfizer vaccines are based on: mRNA technologyNovavax, on the other hand, takes a different approach.
“Today’s approval of Novavax means people can now choose a protein-based, non-MRNA option to protect themselves from COVID-19, which is currently the fourth leading cause of death in the United States.” CEO John Jacobs said. statement.
Closely related descendants of the XBB variant remain. dominant strain Nationally spreading coronavirus statistics, Centers for Disease Control and Prevention To tell.
FDA approval is the last major regulatory hurdle before Novavax’s new shot can be rolled out.
“Today’s authorization represents an additional COVID-19 vaccine that meets FDA’s standards for safety, efficacy, and manufacturing quality necessary to support emergency use authorization,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. It offers options.” release.
At a meeting last month, CDC officials said Said The agency’s Advisory Committee on Immunization Practices said there was no need to reconvene to expand its recommendations to include Novavax.
The authorization also means that many Americans eligible for the protein-based Novavax vaccine, which the company has touted as a “traditional” alternative to Pfizer and Moderna, have been vaccinated to date. This will be my first opportunity to do so.
Previously, Novavax was only authorized as a first booster shot for people who do not want or cannot receive an mRNA vaccine.
When will Novavax’s coronavirus vaccine be available?
Novavax said it has “millions of doses” of the vaccine in the U.S. and expects to ship them “within days” after each batch is approved by the FDA.
The company said doses will be available at “thousands of locations,” including national chain drug stores and clinics.
“Once a batch is released, we are working to ship it quickly and get the product on the shelf and ready for administration,” a Novavax spokesperson said.
Novavax said the vaccine will also be available through the federal government’s Bridge Access and Children’s Vaccine Programs “in the coming days.”
For younger children, the company told investors In August, it was announced that a vaccine is expected to be approved next year.
Why was Novavax’s coronavirus vaccine delayed?
The approval of Novavax’s shot came later than the vaccine maker had hoped. Company executives previously said they planned to enter the U.S. market “by September.”
It’s unclear why Novavax’s plan was approved by the FDA later than Pfizer’s and Moderna’s.
FDA spokeswoman Shelley Duvall Jones said the authorization was “based on submissions made to the agency by vaccine manufacturers” and directed further questions to Novavax.
A Novavax spokesperson said, “Novavax worked closely with the FDA on this EUA to ensure that protein-based options will be part of the fall vaccine offering.”
One possible reason is the timing of the application.
Moderna has submitted an application to the FDA. march and July for the 2023-2024 formula, according to documents released by the agency.Pfizer was included February and June.
Novavax announced In late August, the company announced it had “begun FDA submissions” for its vaccine.
Officials previously acknowledged that it could take longer for the Novavax shot to be updated this fall.
FDA will wait until June to finalize selection of variants for updated coronavirus vaccines, in hopes of increasing the likelihood that the vaccines will closely match those that were in circulation in the fall and winter I let it happen.
At the time, both health officials and Novavax executives acknowledged that a turnaround could be tougher for non-mRNA vaccines, which take longer to manufacture.
In contrast, select strains used in other conventional protein-based vaccines. Annual influenza vaccination It will be manufactured in March to allow enough time for approval and manufacturing.
