American Academy of Family Physicians urges FDA to approve EUA for vaccines for young children

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The American Academy of Family Physicians is urging the Food and Drug Administration to consider emergency use authorization of COVID-19 vaccines for children under the age of 12.

Currently, vaccines are available for children ages 12 and older.

Dr. Ada D. Stewart, president of the AAFP, said the request is being made based on data from the initial cohort enrolled in clinical trials.

"The surge of the Delta variant and the alarming rise in pediatric COVID-19 infections and hospitalizations underscore the need to reevaluate the risk-benefit analysis for this age group, as the risk for severe and long-lasting impacts on health outcomes in unvaccinated children is increasing," Stewart said. "Family physicians play an instrumental role in caring for, counseling, and immunizing children and their families, and are uniquely positioned to discuss and distribute the vaccine in the communities in which they serve."

WHY THIS MATTERS

Children are in school or are getting ready to go back to school in-person for the fall semester as the Delta and other variants continue to plague communities.

Vaccination is currently the leading public health strategy to end the COVID-19 pandemic, Stewart said. It is critical that children under 12 have access to a safe and effective COVID-19 vaccine as soon as possible. 

"As children across the nation return to school in-person, we encourage the FDA to carefully consider the impact of its regulatory decisions on the timing of availability of COVID-19 vaccines for children," she said.

THE LARGER TREND

Both Pfizer and Moderna are in clinical trials for vaccines for children under the age of 12.

In March 2021, Pfizer and BioNTech dosed the first healthy children in a global Phase 1/2/3 continuous study to learn if the vaccine can produce an immune response against COVID-19, and if it is safe, in children aged 6 months to 11 years, Pfizer said. It hopes to submit the vaccine for potential Emergency Use Authorization to the FDA sometime in the September-October timeframe for children 5 to 11, and soon after for 6 months to 5, Pfizer said.

A clinical trial of Moderna's COVID-19 vaccine in children under 12 began at UW Health on Aug. 13, according to the Wisconsin State Journal.

For each child, the study lasts 14 months, including at least four follow-up visits.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com