COVID-19 Vaccine eligibility (via FDA):
- 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 2 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 2 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 Vaccine and Pfizer-BioNTech COVID-19 Vaccine fact sheets.
To more closely target the currently circulating variants of COVID-19 and to provide better protection against infection and serious consequences of the virus, the FDA has approved and granted emergency use authorization (EUA) for updated mRNA, 2024-2025 COVID-19 vaccines, according to a press release from the federal agency.1
The vaccines include a monovalent component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The updates are related to updated mRNA COVID-19 vaccines manufactured by Pfizer and ModernaTX.1
The FDA has also approved a supplemental Biologics License Application for COVID-19 Vaccine, mRNA (COMIRNATY; Pfizer) in individuals aged 12 years and older.1,2
Moderna's COVID-19 vaccine (Spikevax) is approved for people aged 12 years and older. Both the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine are authorized for emergency use in individuals aged 6 months through 11 years.1
"This season’s vaccine is for use as a single dose for most individuals 5 years of age and older," Pfizer said in a statement. "Individuals 5 years of age and older with certain kinds of immunocompromise previously vaccinated with Pfizer and BioNTech COVID-19 vaccines or children under the age of 5 who have not already completed a three-dose series with previous formulas of a COVID-19 vaccine may be eligible to receive additional doses."2
"Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research, FDA, in a statement. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”1
The approval and authorizations come after the FDA advised manufacturers of COVID-19 vaccines that the 2024-2025 formula should be monovalent JN.1 vaccines. Following further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency determined that the preferred JN.1-lineage for the updated vaccines is the KP.2 strain.1
"For [the] approvals and authorizations of the mRNA COVID-19 vaccines, the FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID-19 vaccines," stated the FDA. "The updated mRNA vaccines are manufactured using a similar process as previous formulas of these vaccines."1
The federal agency noted that the updated vaccines are expected to provide protection against variants that are currently circulating, and the agency expects "that the composition of COVID-19 vaccines will need to be assessed annually, as occurs for seasonal influenza vaccines," barring the emergence of a markedly more infectious variant of SARS-CoV-2.1
References:
- FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants. FDA. Press release. August 22, 2024. Accessed August 22, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-and-authorizes-updated-mrna-covid-19-vaccines-better-protect-against-currently?utm_medium=email&utm_source=govdelivery
- Pfizer and BioNTech receives US FDA approval & authorization for Omicron KP.2-adapted COVID-19 Vaccine. Pfizer. Press release. August 22, 2024. Accessed August 22, 2204. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-authorization?cid=em_PfizerNewsroomAlert&ttype=em
