FDA Approves Updated COVID Vaccines From Pfizer And Moderna, But Leaves Out Novavax's Shot

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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.

  • Unvaccinated individuals six months through 4 years of age are eligible to receive three doses of the Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated Moderna COVID-19 Vaccine.
  • Individuals six months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of Moderna or Pfizer-BioNTech COVID-19 vaccines.
  • Individuals 5 through 11 years of age, regardless of previous vaccination, are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose is administered at least 2 months after the last dose of any COVID-19 vaccine.
  • Individuals 12 and older can receive a single dose of Comirnaty or Spikevax.
  • Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in vaccine fact sheets.
  • 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.