FDA proposes shifting to annual COVID-19 boosters targeted at newest strains

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Virus Outbreak New Jersey Vaccine
A person receives the Moderna COVID-19 vaccine in the gymnasium of International High School in Paterson, New Jersey, on Wednesday, January 20, 2021. Paterson’s mayor called on the federal government to provide New Jersey with more coronavirus vaccines as the city’s walk-in site again drew several hundred people. Some of them had lined up at 4:30 a.m. New Jersey has cleared millions to begin receiving the vaccine. Among them are health care workers, first-responders, those 65 and older, and people 16-64 years old with medical conditions. (AP Photo/Ted Shaffrey) (Ted Shaffrey/AP)

FDA proposes shifting to annual COVID-19 boosters targeted at newest strains

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The Food and Drug Administration is proposing shifting its strategy for COVID-19 vaccination similar to that for flu shots in an effort to simplify the country’s vaccine administration as the pandemic stretches into its third year.

The agency asked its vaccine advisory committee to provide input on simplifying the COVID-19 immunization schedule so that healthy adults would be advised to get an annual dose of the most updated COVID-19 shot, while certain younger children, immunocompromised people, and older adults would be recommended to get two COVID-19 shots a year.

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“FDA expects that simplification of COVID-19 vaccine composition and annual immunization schedules may contribute to more facile vaccine deployment, fewer vaccine administration errors, and less complex communication, all potentially leading to improved vaccine coverage rates and, ultimately, to enhanced public health,” the FDA wrote in a briefing document ahead of a Vaccines and Related Biological Products Advisory Committee meeting on Thursday.

The FDA is aiming to establish a process to update the COVID-19 vaccine formula each year by June to match current strains of the virus in hopes of deploying updated shots by September for fall booster campaigns similar to those for flu immunizations.

The changes would streamline the process so that most people are advised to just get one annual COVID-19 booster, a move that the Biden administration indicated would be “sufficient” to provide protection against serious illness and death at this point in the pandemic.

The Vaccines and Related Biological Products Advisory Committee will consider the proposals on Thursday.

The panel will also vote on whether to recommend that the same COVID-19 vaccine formula be used for the primary vaccination series and boosters. The change would mean that Pfizer-BioNTech’s and Moderna’s bivalent COVID-19 vaccines would be administered as part of the two-dose primary vaccination series, which is administered several weeks apart, effectively doing away with the use of monovalent vaccines that only target the original strain of the COVID-19 virus.

“The existence of multiple COVID-19 vaccine compositions, immunization schedules, and differences in vaccine compositions for primary series and booster doses complicate vaccine administration, uptake, and communication,” the FDA wrote.

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Uptake for the bivalent booster, which targets both the original strain of the virus and omicron subvariants BA.4 and BA.5, have been low, with only 15% of people having received an updated shot since it was first made available for people 18 and older last August, according to the Centers for Disease Control and Prevention.

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