US Agency Approves COVID Boosters for Children Aged 12-15

2022-01-03

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WASHINGTON —U.S. health regulators moved again Monday to expand eligibility for booster shots of the Pfizer-BioNTech coronavirus vaccine.

The Food and Drug Administration (FDA) said 12- to 15-year-olds could get the shots as part of an effort aimed at protecting them as schools try to reopen or stay open amid the surging threat posed by the omicron variant of the coronavirus.

In addition, the FDA said everyone who was at least 12 years old could get a booster five months after receiving the second Pfizer-BioNTech shot, compared with the current six-month waiting period. The agency also authorized boosters for some children ages 5 to 11 who have compromised immune systems.

The agency's authorizations are now slated for review Wednesday by the Centers for Disease Control and Prevention and its panel of outside vaccine advisers. Assuming the panel agrees with the FDA's assessment, CDC Director Rochelle Walensky could officially recommend their use later the same day.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement, "A booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be slightly more resistant" to the initial two-dose series of the current vaccines produced by Pfizer and Moderna.

Some schools in the United States, including major universities, have decided, at least temporarily, to revert to remote instruction to curb the spread of the virus. Other school districts are continuing with in-person classes but tightening mask mandates.

In announcing its latest booster approval, Dr. Janet Woodcock, the FDA's acting commissioner, said, "Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind.

"With the current wave of the omicron variant, it's critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight COVID-19," she said.

Nearly 206 million people in the U.S. are fully vaccinated, about 62% of the population, but only about one-third of them, nearly 69 million people, have received booster shots, according to the CDC.

The U.S. has recorded more than 820,000 COVID-19 deaths, the most of any country, the CDC says.