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Pfizer asks FDA to authorize its COVID-19 vaccine for kids ages 5 to 11

The FDA will now have to decide whether the vaccine is safe and effective for elementary school-aged kids.

Pfizer vaccine kids SOPA Images/LightRocket via Getty Images

Pfizer and BioNTech asked the U.S. Food and Drug Administration (FDA) on Thursday (Oct. 7) to provide emergency use authorization for their COVID-19 vaccine for kids ages 5 to 11.

According to the Associated Press, if the vaccine is approved for the cohort, shots could begin within a matter of weeks for the 28 million children who are in that age group. Pfizer and BioNTech stated that their research proved that younger kids should get one-third of the dose that is given to adults. After their second shot, the youngsters should have virus-fighting antibody levels that are just as strong as the older people who received the full dosage.

In September, Pfizer released details of a trial that included 2,268 participants ages 5 to 11. According to the pharmaceutical company, the antibody levels compared well against older people who received the higher dose, proving a “strong immune response in this cohort of children one month after the second dose.”

The FDA will now have to decide whether the vaccine is safe and effective for elementary school-aged kids. Its Vaccines and Related Biological Products Advisory Committee is planning to meet on Oct. 26 to discuss the proposal. If approved, it will become the first COVID-19 vaccine for kids.

Last month, Dr. Fauci predicted that Coronavirus vaccines for kids would be available this fall. “When you talk about the rollout for vaccines there will be a bit of a difference in time frame, maybe by a couple to a few weeks between Pfizer and Moderna, and others,” he said during an interview on ABC “This Week.”

“So, what we’re going to almost certainly see is that sometime in the next few weeks, as we get into October, we’ll be able to see the vaccines for children get enough data to be presented for safety and immunogenicity,” Dr. Fauci added.

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