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Key FDA Panel Backs Pfizer COVID Vaccine for Children Ages 5-11

National Review logo National Review 10/26/2021 Zachary Evans
© Photo illustration: Dado Ruvic/Reuters

A Food and Drug Administration panel voted on Tuesday to recommend use of the Pfizer-BioNTech coronavirus vaccine for children ages 5-11.

The advisory panel, known as the Vaccines and Related Biological Products Advisory Committee, gave its approval to administer the Pfizer vaccine to children in two doses spaced three weeks apart. Children receive one-third of the dosage given to people over the age of 12.

Members of the committee debated whether children under the age of 12 require a coronavirus vaccine, or whether to recommend it only for those at higher risk of complications from COVID-19. Ultimately, 17 committee members voted in favor of broad usage, while one member abstained.

Committee members discussed data on efficacy of the vaccine and the potential risk for side effects. Pfizer and BioNTech reported that their vaccine was 90.7 percent effective at preventing symptomatic COVID-19 in children ages 5-11, and no participant in the companies’ study of children developed myocarditis, a heart-inflammation condition seen in rare instances in young men who received the vaccine.

The FDA as an agency still needs to authorize the vaccine for the 5-11 age group, however the agency generally follows the advisory committee’s recommendations. Authorization will likely be given in the next several weeks, and vaccines for young children could be available sometime in November.

The recommendation comes after the FDA and Centers for Disease Control and Prevention authorized booster shots for all three coronavirus vaccines currently approved for use in the U.S., made by Pfizer and BioNTech, Moderna, and Johnson & Johnson.

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