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January 04, 2022
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CDC backs two FDA moves, waits to hear from ACIP on boosters for kids 12 to 15

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The CDC has backed two COVID-19 vaccine authorizations issued by the FDA but will wait to hear from advisors on whether to recommend booster shots for children aged 12 to 15 years.

Perspective from Paul A. Offit, MD

The CDC updated its recommendations for the Pfizer-BioNTech vaccine to shorten the interval between a primary two-shot series and a booster dose from 6 to 5 months, and to say that moderately or severely immunocompromised children aged 5 to 11 years should receive a third primary series dose of the vaccine 28 days after their second shot.

Source: Adobe Stock.
The CDC will wait to hear from advisors before recommending whether children aged 12 to 15 years should get a booster dose of the Pfizer-BioNTech vaccine. Source: Adobe Stock.

Both recommendations align with an amended emergency use authorization (EUA) issued by the FDA on Monday in the wake of a surge in cases caused by the omicron variant.

However, the CDC did not immediately back a third component of the FDA’s amended EUA that allows booster shots of the vaccine for children aged 12 to 15 years, preferring to hear first from the Advisory Committee on Immunization Practices (ACIP), which will meet on Wednesday to discuss the matter.

CDC Director Rochelle P. Walensky, MD, MPH, said she “look[s] forward” to hearing from the ACIP.

Rochelle P. Walensky

“As we have done throughout the pandemic, we will continue to update our recommendations to ensure the best possible protection for the American people,” Walensky said in a statement. “Following the FDA’s authorizations, today’s recommendations ensure people are able to get a boost of protection in the face of omicron and increasing cases across the country and ensure that the most vulnerable children can get an additional dose to optimize protection against COVID-19. If you or your children are eligible for a third dose or a booster, please go out and get one as soon as you can.”

The ACIP is scheduled to meet on Wednesday from 1 to 5 p.m. ET.

Booster doses of the Pfizer-BioNTech COVID-19 vaccine were already authorized for adolescents aged 16 and 17 years under an amended EUA issued by the FDA last month, which the CDC supported without hearing from the ACIP.

The vaccine remains the only COVID-19 shot authorized for any pediatric group. The FDA has delayed a decision on authorizing the Moderna vaccine for children aged 12 to 17 years so it can further review the messenger RNA vaccine-related risk for myocarditis or pericarditis in this age group.