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Pfizer Asks FDA to Greenlight COVID Shots for Kids 5-11, Could Roll Out Pre-Thanksgiving

By Asher Lehrer-Small | October 7, 2021

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Updated Oct. 8

In a key step toward coronavirus vaccine access for over 28 million U.S. children, Pfizer-BioNTech announced Thursday morning that they have submitted their formal request to federal regulators for authorization to deliver shots to youth ages 5 to 11.

The move comes after the pharmaceutical companies announced positive topline results among that age group in clinical trials in late September. The testing regimen delivered two reduced-potency doses to more than 2,000 youngsters, producing a “robust” antibody response, including immunity and side effects comparable to that produced by the larger dose in 16- to 25-year-old patients. 

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” Pfizer tweeted Thursday.

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The Food and Drug Administration has an Oct. 26 advisory committee meeting scheduled to review Pfizer-BioNTech’s request to expand authorization to younger children. 

Pressed on what issues will be on the table during that meeting and how soon afterward authorization might be granted, a spokesperson responded to The 74 that the “FDA cannot comment on its interactions with manufacturers about their investigational products.”

Should the review process follow a similar timeline as it did for 12- to 15-year olds, which stretched just over a month from an April 9 submission to a May 10 authorization, children ages 5 to 11 could receive the greenlight for COVID immunizations by early- to mid-November, sometime between Halloween and Thanksgiving.

Meanwhile, schools are facing a third straight school year disrupted by the virus, which as of last week had killed 700,000 Americans even as cases overall have begun to fall. As of Sunday, outbreaks had triggered some 2,238 school closures across 561 districts since buildings opened their doors for the 2021-22 school year, according to the website Burbio, which has tracked school policies and schedules through the pandemic.

Although children rarely fall seriously ill from the virus, the Delta variant has driven up caseloads among unvaccinated Americans, including youth. Last week, over 173,000 pediatric cases were reported, accounting for over a quarter of new cases nationwide, according to the American Academy of Pediatrics.

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Vaccines are currently authorized for youth ages 12 to 15, and fully approved for those 16 and up. As of Sept. 29, 56 percent of 12- to 17-year olds in the U.S. had received at least one dose of the vaccine, according to the pediatrics academy, while 68 percent of adults 18 and older are fully vaccinated.

Youth immunization rates, however, vary greatly by locale. In 10 states, over two-thirds of children ages 12 to 17 have received at least one dose of the vaccine, while in 21 states, the same is true for less than half of youth that age.

Last week, California Gov. Gavin Newsom announced that coronavirus vaccines will be required for all eligible students in the state, though the rule will likely not go into effect until July 2022.

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Some districts have moved to implement more immediate mandates for children ages 12 and up including Los Angeles, Oakland and Culver City, all in California; and Hoboken, New Jersey. Washington D.C. is also mulling a bill that would require all students to be fully immunized against the virus by Dec. 15.

Though it may prove a challenge to persuade the parents of K-12 students to receive vaccinations in some districts, COVID shots are the most effective way to defend children against the virus, Benjamin Linas, professor of medicine at Boston University, told The 74 last month.

“With the vaccine, you’re very well protected from the bad outcomes.”

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