(Aug. 30, 2024) – Last week, the Food and Drug Administration approved the Pfizer-BioNTech and Moderna updated (2024 – 2025 formulation) COVID-19 vaccines. Here are the highlights from the FDA approval announcement.
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. Manufacturers were expected to begin shipping their updated vaccines immediately upon approval.
What You Need to Know
Unvaccinated individuals six months through four years of age can receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated, authorized Moderna COVID-19 Vaccine.
Individuals six months through four 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 five 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 after the last dose of any COVID-19 vaccine.
Additional doses are authorized for certain immunocompromised individuals ages six months through 11 years of age as described in the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine fact sheets.
For more details, please see the full FDA announcement.
--Karen Braman