Coronavirus

FDA-Approved Covid Vaccine for Kids Ages 5 to 11 ‘Very Feasible' by Halloween, Says Former FDA Commissioner

Trung Nguyen, 13, gets his second dose of the coronavirus disease (COVID-19) vaccine at the Philadelphia Zoo in Philadelphia, Pennsylvania, September 7, 2021.
Rachel Wisniewski | Reuters
  • Pfizer and BioNTech’s Covid vaccine is safe and appears to generate a robust immune response in a clinical trial of kids 5 to 11, the drugmakers announced.
  • “Those findings are very promising, especially around the ability of a very small dose, leading to a very strong immune reaction,” said former FDA Commissioner Dr. Mark McClellan.
  • “It is going to be a thorough process at the FDA,” McClellan said. “They look at all the actual data, replicate the studies that are reported.”

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Former Food and Drug Administration Commissioner Dr. Mark McClellan told CNBC that it seems realistic that younger kids will be getting vaccinated for Covid-19 based on the new data released by Pfizer on Monday.

"Those findings are very promising, especially around the ability of a very small dose, leading to a very strong immune reaction," said McClellan, a health policy expert with Duke University. "So it's good that that's panning out and action by the FDA in a month seems very feasible." 

Pfizer announced that its Covid-19 vaccine is both safe and effective in children ages 5 to 11. Officials at Pfizer say they plan to submit their data to the FDA by the end of the month. If the review process goes as smoothly as it did for adolescents and adults, then shots could be available for 5- to 11-year-olds by Halloween. 

McClellan explained the FDA's rigorous review process during a Monday evening interview on "The News with Shepard Smith." 

"It is going to be a thorough process at the FDA," McClellan said. "They look at all the actual data, replicate the studies that are reported."

Children currently account for nearly 30% of all new infections nationwide, according to the American Academy of Pediatrics. For context, children made up just 15% of all U.S. cases during the January peak. 

When it comes to the overall fight to combat Covid, McClellan told host Shepard Smith that if children can start getting vaccinated, "it will make a big difference in keeping schools safer in preventing the kinds of spread that we're seeing now."

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