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Thursday, the FDA granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2.
The approval comes for the updated vaccines from Moderna Inc (NASDAQ:MRNA) and Pfizer Inc (NYSE:PFE) / BioNTech SE (NASDAQ:BNTX).
The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death.
In early June, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines.
Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain, if feasible.
The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals six months through 11 years of age.
The FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID-19 vaccines.
Moderna said the Spikevax 2024-2025 formula is expected to be available across the U.S. in the days immediately following approval.
Pfizer also said shipping will begin immediately.
Novavax Inc’s (NASDAQ:NVAX) COVID-19 vaccine was left out in today’s approval. Earlier, the company mentioned that it anticipates commercial delivery of the protein-based vaccine in the U.S. in September, pending authorization.
Price Action: PFE stock is down 1.18% at $28.69, BNTX stock is down 0.85% at $88.23, MRNA stock is down 5.08% at $82.25, and NVAX stock is down 5.72% at $12.20 at last check Thursday.
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