Monday, May 10, 2021

FDA authorizes Pfizer-BioNTech COVID vaccine for 12- to 15-year-olds

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The Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech coronavirus vaccine for 12- to 15-year-old adolescents, the agency announced on Monday.

Why it matters: The emergency authorization marks a critical milestone in the push to get more Americans vaccinated and fully reopen schools for in-person learning this fall.


  • Pfizer has said its vaccine was 100% effective at protecting against COVID-19 in a trial of more than 2,200 children between the ages of 12 and 15.

What they’re saying: “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data,” said Acting FDA Commissioner Janet Woodcock.

The big picture: Children are at a low risk for serious illness from COVID-19, but experts say allowing the virus to circulate among unvaccinated kids could lead to new, more dangerous variants and slow down the protection of adults.

  • Still, about 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention, since the beginning of the pandemic.
  • The FDA has already authorized Pfizer’s vaccine for people 16 and older. Moderna and Johnson & Johnson also have trials for teens underway.

Yes, but: Parents’ enthusiasm for the incoming emergency use has so far been mixed, even among those who themselves have been vaccinated.

  • Only 52% of parents of a child under 18 said they’re likely to vaccinate their kids as soon as they’re able, according to an Axios/Ipsos survey from April.
  • In a separate survey from KFF, 32% of parents said they’ll wait to see how the vaccine works before getting their child vaccinated, and 19% said they definitely wouldn’t get their child vaccinated. 

What’s next: Moderna is expected to announce trial results for adolescents ages 12 to 17 in the second half of 2021, the New York Times reports.

Source: https://www.axios.com/covid-vaccine-pfizer-adolescents-fda-4420a00e-0a76-42da-83c0-263b79ecbc17.html
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The Article Was Written/Published By: Shawna Chen



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