FDA Approves New COVID-19 Booster Shots

MONDAY, Sept. 11, 2023 (HealthDay News) -- The U.S. Food and Drug Administration on Monday gave the green light to new COVID-19 boosters for Americans, setting the stage for the updated vaccines to become available within days.

The COVID-19 shots from Pfizer and Moderna will join the flu shot and newly approved RSV shots as part of a three-pronged public health strategy to tame the spread of all three viruses this coming winter. The updated COVID-19 vaccines are each fully approved for those aged 12 years and older and are authorized under emergency use for individuals 6 months through 11 years of age.

The Advisory Committee on Immunization Practices is set to meet Tuesday to make recommendations on who should get the new booster shots. Mandy Cohen, M.D., director of the U.S. Centers for Disease Control and Prevention, could sign off soon after, allowing vaccinations to begin.

In its approval, the FDA recommended the following eligibilities for Americans: Those aged 5 years and older, regardless of previous vaccination, can receive a single dose of an updated COVID-19 vaccine at least two months since the last dose of any COVID-19 vaccine; individuals aged 6 months through 4 years who have been vaccinated against COVID-19 can receive one or two doses of an updated COVID-19 vaccine (depending on the previous COVID-19 vaccine received); and unvaccinated individuals aged 6 months through 4 years can receive three doses of the updated Pfizer COVID-19 vaccine or two doses of the updated Moderna COVID-19 vaccine.

The boosters target the XBB.1.5 omicron subvariant. That is no longer the dominant variant circulating, but those that are spreading widely are closely related, and health experts say this booster will still offer some protection.

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