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September 11, 2023September 11, 2023 - Pfizer Inc. and BioNTech SE have announced that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (COMIRNATY 2023-2024 Formulation) for individuals 12 years and older and granted emergency use authorization for individuals 6 months through 11 years of age for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.
According to the Centers for Disease Control and Prevention, everyone six months and older should receive an updated COVID-19 booster this fall. The recommendation followed a vote from the CDC’s advisory committee on Tuesday. The companies are working closely with pharmacies, hospitals, and clinics across the country to ensure rapid access to this season’s vaccine. The new COVID shots, made by Pfizer and Moderna, are expected to be available within 48 hours in some areas.
This season’s vaccine is indicated as a single dose for most individuals 5 years of age and older. Children under the age of 5 may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.
Key points regarding the updated vaccines are summarized below:
- Individuals 5 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 since the last dose of any 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 an updated mRNA COVID-19 vaccine (depending on the previous COVID-19 vaccine received).
- Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer vaccine or two doses of the updated authorized Moderna COVID-19 vaccine.
- The FDA is still reviewing an updated vaccine from Novavax for individuals 12 years of age and older.
The first doses of the new vaccines will be imminently available to eligible individuals at pharmacies, health clinics, and community centers, according to the CDC.