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Oct. 25, 2021, 8:10 a.m. EDT

FDA committee to discuss BioNTech/Pfizer's COVID-19 shot in children 5 to 11

A Food and Drug Administration advisory committee is set to meet Tuesday to discuss and then recommend whether the benefits outweigh the risks of BioNTech SE (NAS:BNTX) and Pfizer Inc.'s (NYS:PFE) COVID-19 vaccine in children between the ages of 5 and 11 years old. The FDA is not required to follow the advice of the committee but often does. The regulator's decision has come within a week of the advisory committee's recommendation in the past. The BioNTech/Pfizer vaccine is currently authorized for teens between the ages of 12 and 15 years old and fully approved for those individuals 16 years and older. If it receives emergency-use authorization, Comirnaty would be the first COVID-19 shot available in the U.S. for this age group. The FDA said Friday that the vaccine generated an efficacy rate of 90.7% against symptomatic infection in 2,268 elementary school-age children seven days after they got the second shot. The most common side effects occurred after the second dose and included pain at the injection site, fatigue, and headache. There were no serious adverse events associated with the vaccine, according to the FDA. The proposed dose for 5- to 11-year-olds is 10 µg, compared with 30 µg used in those 12 years old and older.

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