Updated COVID Vaccines Approved by FDA
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved and granted emergency use authorization 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 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. Today’s actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.
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 and Pfizer-BioNTech COVID-19 vaccines, both of which are authorized for emergency use for individuals 6 months through 11 years of age.
Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated, authorized Moderna COVID-19 vaccine. Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
Individuals 5 years 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 two months after the last dose of any COVID-19 vaccine. Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated, the dose is administered at least two months since the last dose of any COVID-19 vaccine.
Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years of age as described in the Moderna COVID-19 and Pfizer-BioNTech COVID-19 vaccine fact sheets.
For approvals and authorizations of the mRNA COVID-19 vaccines, FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula. The updated mRNA vaccines are manufactured using a similar process as previous formulas of these vaccines.
