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U.S. FDA proposes shift to annual COVID vaccine shots


A nurse fills up syringes with the coronavirus disease (COVID-19) vaccines for residents who are over 50 years old and immunocompromised and are eligible to receive their second booster shots in Waterford, Michigan, U.S., April 8, 2022. REUTERS/Emily Elconin

The U.S. health regulator on Monday proposed the use of one dose of the latest updated COVID-19 shot annually for healthy adults, similar to the influenza immunization campaign, as it aims to simplify the country’s current COVID-vaccine strategy.

The Food and Drug Administration’s proposal was outlined in its briefing documents ahead of a meeting of its panel of external advisers on Thursday.

It has also asked the panel to consider the usage of two COVID vaccine shots a year for some young children, and in older adults and persons with compromised immunity.
The regulator also sought its advisers’ views on the need for routine selection of variants for updating the vaccine, similar to the way strains for flu vaccines are changed annually.
The agency’s proposal was on expected lines, following its announcement of its intention for the update last month.

The Biden administration has also been planning for a campaign of vaccine boosters every fall season.

The agency expects that simplifying the COVID vaccine composition and annual immunization schedules may contribute to less complicated vaccine deployment, fewer vaccine administration errors and less complex communication, which could potentially lead to improved vaccine coverage rates.

Currently, most people in the United States need to first get two doses of the original COVID vaccine spaced 3-4 weeks apart, depending on the vaccine, followed by a booster a few months later.

If the panel votes in favor of the proposal, Pfizer Inc’s (PFE.N) and Moderna Inc’s (MRNA.O) bivalent vaccines, which target both the Omicron and the original variants, would be used for all COVID vaccine doses, and not just as boosters.

The FDA’s proposal follows the European regulator’s backing last month for the use of bivalent COVID shots for primary vaccination.