Pfizer seeks FDA authorization for vaccine's use in kids 5-11: 5 things to know

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Pfizer said Oct. 7 it submitted its request for the FDA to extend its COVID-19 vaccine's emergency use authorization to include children between ages 5 and 11.

Five things to know:

  1. The FDA has tentatively scheduled a meeting on Oct. 26 to review Pfizer's request. The agency's decision is expected between Oct. 31 and Nov. 25, according to The New York Times.

  2. On Sept. 20, Pfizer released trial data from a phase 2/3 study that included 2,268 participants ages 5-11. The drugmaker said the trial demonstrated a "favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age." The findings have not been peer reviewed or published in a scientific journal.

  3. During the trial, participants received two 10-microgram doses of Pfizer's COVID-19 vaccine, administered 21 days apart. For people ages 12 and older, Pfizer uses a 30-microgram dose.

  4. In May, the FDA authorized Pfizer's COVID-19 vaccine to be used in children between ages 12 and 15. Since then, more than 8.2 million children in that age group have gotten at least one dose, and 6.7 million have gotten two doses, according to The New York Times.

  5. Of the drugmakers with a COVID-19 vaccine in use in the U.S., Pfizer is the first one to produce results from a trial testing its vaccine in children ages 5 to 11. 
 

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