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Adolescent getting vaccinated

FDA authorizes COVID boosters for youths ages 12-15; AAP updates treatment guidance

January 3, 2022

Update on boosters: On Jan. 4, the CDC director signed off on third doses of Pfizer-BioNTech COVID-19 vaccine for immunocompromised children ages 5-11 years and a new booster time interval for Pfizer recipients. The CDC vaccine committee will meet Jan. 5 to discuss boosters for adolescents ages 12-15 years.

Update on COVID management guidance: The guidance on COVID-19 management has been updated since this story was published. Please consult the guidance document for the latest information.

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The Food and Drug Administration (FDA) authorized COVID-19 vaccine boosters for adolescents ages 12-15 years on Monday amid surging case counts.

Health officials also shortened the time interval for boosters after a Pfizer-BioNTech primary series and will allow a third primary series dose for certain immunocompromised children ages 5-11 years.

“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,” Acting FDA Commissioner Janet Woodcock, M.D., said in a news release.

The Centers for Disease Control and Prevention’s (CDC’s) vaccine advisory committee will meet Wednesday to discuss these actions and then the CDC director will need to sign off on them.

In expanding Pfizer-BioNTech boosters down to 12 years, the FDA said it looked at data on more than 6,000 adolescents from Israel that did not show new safety concerns. FDA Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., said Monday the risk of myocarditis after a third dose of vaccine is about one-third to one-half the risk after a second dose. He also noted 98% of myocarditis cases after vaccination have been mild with a median hospitalization of one day.

“In the setting of a tremendous number of omicron and delta cases in this country, the potential benefits of getting vaccinated in this age range outweigh that risk,” he said.

About 53% of adolescents ages 12-17 years are fully vaccinated, according to an AAP analysis of CDC data.

The FDA’s COVID-19 vaccine updates on Monday also included changing the time interval for a booster. People ages 12 and older who had a Pfizer-BioNTech primary series can get a booster at five months instead of six. Adults who received a Johnson and Johnson vaccine still need to wait only two months for a booster, and those who initially received Moderna still need to wait six months for a boost.

In another move, the FDA said children ages 5-11 years who have undergone solid organ transplantation or have been diagnosed with conditions with an equivalent level of immunocompromise can receive a third primary series dose at least 28 days after the second dose.

AAP guidance on COVID management

The AAP has updated its interim guidance on managing mild to moderate COVID-19 in the wake of the FDA finding only one monoclonal antibody therapy authorized for children may be effective against the omicron variant.

Sotrovimab is expected to work against omicron, which has numerous mutations. However, supply of the therapy is extremely limited. The therapy can be given within 10 days of symptom onset to non-hospitalized children who have COVID-19 and are at high risk of progressing to severe disease. They must be at least 12 years old and weigh at least 40 kilograms.

The AAP interim guidance also discusses the use of monoclonal antibodies for post-exposure and pre-exposure prophylaxis. Pediatricians should refer to up-to-date recommendations in their geographic area and partner with local pediatric hospitals, pediatric infectious disease specialists and health departments to inquire about availability of monoclonal antibody therapy.

The FDA also recently granted emergency use authorization to oral antiviral medications Paxlovid and molnupiravir for people at high risk of severe COVID-19. Paxlovid was authorized for children as young as 12 years, but trials were done in adults and there are no data on safety or efficacy in children. The AAP will update its guidance on this treatment when more data become available.



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