The Food and Drug Administration has granted emergency use approval for Gaithersburg, Maryland-based Novavax’s updated COVID-19 booster shot, nearly three weeks after approving mRNA vaccine updates from Pfizer and Moderna.
The Novavax vaccine still must get approval from the Centers for Disease Control and Prevention before being made publicly available. Both the Pfizer and Moderna vaccines received CDC approval last month and have been publicly available for several weeks.
The FDA action approved the Novavax vaccine for ages 12 and up. Novavax said shots will be available “in the coming days.”
The Novavax vaccine has long been considered a viable alternative to people who have concerns about mRNA vaccines. It is a traditional, protein-based vaccine.
Last month, Novavax said the updated vaccine showed broad immune response against two fast-spreading variants of the COVID-19 virus. Last month, it also said doses of the vaccine were produced, arrived in the U.S. and are ready for release after receiving regulatory approvals.
The company announced a series of cost reductions last May, including eliminating 25% of its workforce.
Novavax signed a three-year agreement with the Bill & Melinda Gates Medical Research Institute in June to make its vaccine adjuvant available for use in pre-clinical vaccine research.
Its Matrix-M adjuvant is the basis for its protein-based COVID-19 vaccine, and is being used in development of new influenza and combination influenza-COVID vaccines. An adjuvant is an ingredient in some vaccines to help create a stronger immune response.
While Pfizer and Moderna have shipped millions of doses, the fall rollout so far has been messy since, for the first time, the government isn’t buying and distributing the COVID-19 shots. Ordering confusion from drugstores and doctors’ offices, distribution delays and even bungled paperwork by insurance companies snarled early appointments.
The updated vaccine versions are supposed to be free through private insurance or Medicare, and the CDC has a program to temporarily provide free shots to the uninsured or underinsured.
The Associated Press contributed to this report.