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FDA clears booster shot of Pfizer vaccine for 16- and 17-year-olds amid alarm over omicron



The Food and Drug Administration on Thursday authorized a booster shot of the Pfizer-BioNTech Covid-19 vaccine for 16- and 17-year-olds for emergency use.

The FDA’s move opens up additional shots to more Americans amid growing alarm over the omicron variant and the continued spread of the delta variant. The agency has already authorized boosters from Pfizer, Moderna and Johnson & Johnson for all adults on an emergency use basis.

Acting FDA Commissioner Dr. Janet Woodcock said boosters, along with other preventative measures, remain the nation’s most effective method for fighting Covid.

“With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19,” she said in a statement.

The Centers for Disease Control and Prevention still needs to sign off before the booster shots can be administered. A meeting of the agency’s Advisory Committee on Immunization Practices hasn’t been scheduled yet.

The Pfizer booster would be available to 16- and 17-year-olds at least six months after they received their second dose of the Pfizer vaccine. Because Pfizer’s vaccine and booster shots are the only ones that have been cleared for use in children under 18, “mixing and matching” vaccines and boosters is not an option for this age group. The Moderna and Johnson & Johnson vaccines are authorized for adults 18 and up.

Children under age 18 made up about 22.4 percent of all reported Covid cases nationwide in the week ending Dec. 2, according to American Academy of Pediatrics. They make up about 22.2 percent of the total U.S. population.

Even though children are less likely than adults to suffer from severe outcomes from Covid, a small portion of them do, public health officials and health experts say. More than 5,900 kids have experienced MIS-C, or multisystem inflammatory syndrome in children, a rare but serious Covid-related complication, according to the CDC. Fifty-two children have died from it, according to the agency.

Kids as young as 5 are eligible to receive the initial two doses of Pfizer’s and BioNTech’s vaccine.

The companies asked the FDA to expand emergency use authorization of their booster for older teens on Nov. 30, according to Pfizer CEO Albert Bourla.

The authorization comes as some health experts discuss whether it is appropriate to use the existing vaccines as boosters, and if it would be better instead to wait for an omicron-specific vaccine.

Early data from laboratory studies show the initial two-dose series of the Pfizer-BioNTech vaccine appears to be less effective against omicron, but the companies said Wednesday a booster shot appears to provide strong protection against the new variant.

Dr. Anthony Fauci, the White House’s chief medical adviser, told “Andrea Mitchell Reports” on MSNBC on Wednesday that there’s “no doubt” among federal health officials that a booster provides “optimal protection” against the virus and its variants.

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