Pfizer Asks OK for Younger Recipients

FDA approval probably is a few weeks away
By Bob Cronin,  Newser Staff
Posted Apr 9, 2021 4:45 PM CDT
Pfizer Asks OK for 12- to 15-Year-Olds
Alejandra Gerardo, 9, looks up to her mom, Dr. Susanna Naggie, as she gets the first of two Pfizer COVID-19 vaccinations during a clinical trial for children at Duke Health in Durham, NC, last month.   (Shawn Rocco/Duke Health via AP)

Pfizer asked the Food and Drug Administration on Friday to add recipients ages 12 to 15 to the emergency use authorization for its coronavirus vaccine. At the moment, Pfizer has permission to distribute the vaccine for anyone 16 or older. The company said last week that its trials showed its vaccine to be 100% effective in recipients 12 to 15; those results have not been peer-reviewed, per NBC. "Vaccinating our teenagers is the next step in seeing our way through the pandemic," said an expert at the Vanderbilt University Medical Center in Nashville. Changing the use authorization probably will take a few weeks. A former FDA official said the agency won't have to consult its independent advisory panel, as it did before the first approval. But the agency might ask the panel to display transparency, he said.

If approved, that age group could be vaccinated in time for the return to school in the fall, per the New York Times. Pfizer has begun assessing the vaccine's efficacy in children 6 months to 12 years old; those trials began last month, and the results are due in the second half of the year. The trials for children started slowly partly because it took a while to find study participants. Teenagers and younger children are part of the reason coronavirus case counts are climbing in some places. Michigan, for example, has more infections among those ages 10 to 19 than ever. Pfizer said it will ask other nations for similar approvals soon. Moderna also has trials for children and teenagers in progress. (More Pfizer stories.)

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