Here is who is eligible for which vaccination, according to the FDA:
• Children aged 5 years through 11 years, 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 must be administered at least 2 months after the last dose of any COVID-19 vaccine
• Exceptions are made for children aged 6 months through 11 years who are immunocompromised. Those children should complete at least a three-dose series with either mRNA COVID-19 vaccine, each dose 1 month apart. That agency adds that at least one dose should be with a COVID-19 vaccine (2024–2025 formula)
• Immunocompromise for these purposes includes children who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise
• Those aged 12 years of age and older—adolescents and adults—are eligible to receive a single dose of the updated, approved Comirnaty from Pfizer-BioNTech or the updated approved Spikevax from Moderna. If previously vaccinated, the dose is administered at least 2 months since the last dose of any COVID-19 vaccine.
Vaccine providers approved to provide shots for younger children should know that unvaccinated infants and toddlers aged 6 months through 4 years 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. Those children aged 6 months through 4 years 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).
Both manufacturers said the approved 2024–2025 products would begin shipping almost immediately after approval on August 22.
The new vaccines include a monovalent component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The FDA noted in a press release that “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.”
The FDA’s action specifically relates to updated mRNA COVID-19 vaccines manufactured by ModernaTX, Inc., and Pfizer, Inc.
Manufacturers of licensed and authorized COVID-19 vaccines were advised by the FDA in early June that the new vaccines should be monovalent JN.1 versions. With the further evolution of SARS-CoV-2—including a rise in cases of COVID-19—the FDA later determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024–2025 formula) was the KP.2 strain, if feasible.
“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “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.”
The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals aged 12 years and older, and the Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine, both of which were granted EUA for individuals aged 6 months through 11 years.
A third U.S. manufacturer, Novavax, expects its modified vaccine version to be available soon.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
