Pfizer, Moderna COVID-19 Shots Work for Children Under 5, FDA Says

MONDAY, June 13, 2022 (HealthDay News) -- Antibody levels suggest that three doses of the Pfizer pediatric COVID-19 vaccine help guard children younger than 5 years against infection, a new analysis from the U.S. Food and Drug Administration shows.

The findings were posted online Sunday ahead of an FDA advisory panel meeting scheduled for Wednesday. On that day, the panel will weigh whether the FDA should authorize the use of both the Pfizer and Moderna COVID-19 vaccines for young children. On Friday, the FDA said the Moderna vaccine was effective in preventing symptomatic illness in children younger than 6 years with minimal side effects.

If the FDA authorizes both vaccines for young children -- as expected by public health experts -- the U.S. Centers for Disease Control and Prevention would also have to give the vaccines the green light before they become available to the approximately 18 million U.S. children who are younger than 5 years. They are the only age group in the nation not currently eligible for COVID-19 shots.

The data submitted by Pfizer from its clinical trial suggest that three doses of the vaccine are more effective than two in young children and also show that there were minimal side effects, according to the FDA staff analysis. Still, the agency said there were so few cases of COVID-19 among the 1,415 children who received three doses of the vaccine that it was hard to draw a definitive conclusion on the shots.

"Given the uncertainty of the COVID-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on COVID-19-associated morbidity and mortality in this age group," the FDA documents stated.

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