A panel of independent advisors to the Food and Drug Administration is recommending emergency use authorization for the Pfizer BioNTech vaccine in children ages 5 to 11 years old. The vote was 17 in favor of the vaccine and 1 abstention.
Pfizer’s data has shown the vaccine is safe and 90.7% effective in preventing Covid-19 infections in the new age group, and the FDA panel has accepted this data.
The vaccine provides a broad defense against Covid-19 and effectively neutralizes the delta variant in young kids. A dose of Pfizer for young children contains 1/3 of the amount of the active ingredient compared to the adult dose. Children would receive two does, where the second dose is given 21 days or more after their first shot.
The senior VP of vaccine clinical research and development at Pfizer states the dose size was chosen to create the right balance between providing strong immunity and limiting side effects and said the observed adverse effects seen in studies didn’t alert any safety concerns, with the FDA panel supporting the conclusion.
Children 5-11 years of age have accounted for approximately 95 of reported Covid-19 cases in the U.S. overall, and currently account for approximately 40% of all pediatric Covid-19 cases. The panel has acknowledged the serious effects of Covid-19 infection, including long Covid-19, hospitalizations and death, although less frequent in children than adults. However, unvaccinated children with Covid-19 can develop a serious complication called multi system inflammatory syndrome or MIS-C, as well as an inflammation of the heart muscle called myocarditis.
Most in the public health community see an urgent need to get vaccinations started in young school-age children. The FDA modeled one scenario to estimate the effect of vaccinating children, showing that vaccinating 1 million kids ages 5 to 11 would prevent 58,000 infections, 241 hospitalizations and one death.
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