Updated COVID Vaccines Approved by FDA

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 SARSCoV-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 COVID19, 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 COVID19 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 COVID19 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 PfizerBioNTech 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.     ❖