FDA sets meetings for Moderna, J&J boosters and COVID-19 vaccines for children

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BERLIN, GERMANY – JANUARY 19: Vaccine vials from Biotec Pfizer vaccinated against Covid-19 at the vaccination center in Berlin Schoeneberg on January 19, 2021 in Berlin, Germany. (Photo by Florian Gaertner/Photothek via Getty Images)

(WHNT) — Federal health officials will look at approving COVID-19 boosters from Moderna and Johnson & Johnson this month – and await Pfizer’s request to approve its vaccine for children 5 and up.

On Friday, the U.S. Food and Drug Administration (FDA) announced two upcoming meetings to discuss emergency use authorization of Moderna’s and Janssen’s Johnson & Johnson booster shots for October 14 and 15, respectively.

During the meetings, both company representatives and FDA officials will present research on the efficacy of a third dose.

“Vaccines are one of the most important interventions for bringing an end to the ongoing pandemic,” said Dr. Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations.”

Both companies’ COVID-19 vaccines are authorized for emergency use in those 18 years and older. Currently Pfizer’s vaccine is the only one approved for children 12 to 17.

The FDA is also anticipating Pfizer to request an amendment to its emergency use authorization to allow for children ages 5 to 11 to receive its COVID-19 vaccine. That meeting is slated for October 26.

We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” said Acting FDA Commissioner Janet Woodcock, M.D. 

For more information and livestream links to the FDA’s upcoming meetings, click here.

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