The FDA has announced important changes to COVID vaccine guidelines and eligibility for the general U.S. population, as well as for special categories such as young children, older adults, and immunocompromised persons. Drs. Robert Califf and Peter Mark briefly outlined these key changes in an April 20th webinar. The Emergency Use Authorization has been extended for both the Modern and Pfizer updated bivalent formulations of the COVID vaccine for a period of five years. Henceforth, only the updated bivalent formulations may be used for vaccinations, and only one (1) administration of this updated vaccine is needed to be “up to date.” Generally, individuals who are already “up to date” do NOT need to have the updated vaccine to continue to be “up to date.” Those who have NOT completed their original vaccine series OR have never been vaccinated will have to have one (1) administration of the updated vaccine to be “up to date.”
Special categories of administration were next addressed. For those ages 65 or older (or immunocompromised), there is evidence that the immune response to COVID wanes after four months; therefore, they are considered up to date if they have had one bivalent dose. But they are eligible for another dose of the updated bivalent vaccine four months following their last shot. For children, those who are younger than 5 and receiving Pfizer, or younger than 6 and receiving Moderna will still need the same initial series and dosage but using the updated bivalent formulation. Individuals with specific questions or who fall outside of the special categories are encouraged to consult their primary care physician. This is not a “new” vaccine and has been in use since September 2022. However, it is NOT considered a booster, but rather is a modified formulation to adjust to the current strains of COVID, and it will become the single-vaccine standard for becoming “up to date.”