(Sept. 15, 2023) – This week, the Food and Drug Administration approved and authorized the updated Pfizer and Moderna COVID-19 vaccines. The updated monovalent mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals six months through 11 years of age.
As part of the FDA's actions, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. The updated vaccines are expected to provide good protection from currently circulating COVID-19 variants. The FDA anticipates the composition of COVID-19 vaccines may need to be updated annually as with the seasonal influenza vaccination.
The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices met earlier this week and recommended the updated COVID-19 vaccines for everyone six months of age and older. After the ACIP recommendation, the CDC recommended a COVID-19 vaccine updated for 2023-2024 for everyone age six months and older to protect against serious illness. Information about the current updated COVID-19 vaccines, highlighted in this week's FDA announcement, includes:
- Individuals five years of age and older, regardless of previous vaccination, are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least two months after the last dose of any 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 an updated mRNA COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
- Unvaccinated individuals, six months through four 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.
For more detailed information, see the Pfizer vaccine healthcare provider fact sheet or the Moderna vaccine healthcare provider fact sheet. It is anticipated the updated COVID vaccines will be available in the coming days. The Novavax vaccine, which is a protein-based non-mRNA vaccine, is still pending FDA and CDC action.
--Karen Braman