Home Business FDA approves Novavax’s enhanced COVID vaccine for autumn 2023.

FDA approves Novavax’s enhanced COVID vaccine for autumn 2023.

FDA approves Novavax’s enhanced COVID vaccine for autumn 2023.

The Food and Drug Administration (FDA) has authorized Novavax’s updated COVID-19 vaccine, providing Americans ages 12 and older with a third option for vaccination. Novavax’s updated shot specifically targets 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. This authorization allows individuals to choose a protein-based, non-mRNA option to protect against COVID-19, which has become the fourth leading cause of death in the U.S.

The dominant strains of coronavirus currently circulating in the U.S. are closely related descendants of the XBB variant, according to the Centers for Disease Control and Prevention (CDC). The FDA’s authorization is the final major regulatory hurdle before Novavax’s new vaccines can be rolled out. Previously, Novavax was only authorized as a first booster dose for those who were unwilling or unable to receive an mRNA shot. This marks the first time that many previously vaccinated individuals will be eligible to receive the protein-based Novavax vaccine.

Novavax has stated that it has “millions of doses” of its vaccine ready for shipment in the U.S. The company plans to ship these doses to various locations, including national chain drug stores and doctors’ offices, in the coming days. Shots will also be available through the federal Bridge Access and Vaccines for Children program. It is not clear why Novavax’s vaccine was authorized later than vaccines from Pfizer and Moderna, but the timing of the applications could be a possible reason. Novavax officials had previously acknowledged that their shots might take longer to update for this fall, as non-mRNA vaccines generally have a longer manufacturing time.

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