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COVID-19 Updates » Pfizer Requests FDA Clearance for Vaccine in Kids Ages 12 to 15

Pfizer Requests FDA Clearance for Vaccine in Kids Ages 12 to 15


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April 14, 2021 at 12:20 PM

Pfizer on Friday requested to expand use of its Covid-19 vaccine to adolescents ages 12 to 15.

The request asks the Food and Drug Administration to amend the emergency use authorization, which the FDA originally granted late last year for people ages 16 and up.

Last week, Pfizer-BioNTech said its Phase 3 clinical trials showed its vaccine was safe and 100 percent effective in 12- to 15-year-olds, though the findings have not been peer-reviewed.

"The hope of starting to vaccinate this age group before the start of the next school year," CEO Albert Bourla said in a statement when those results were released.

"Vaccinating our teenagers is the next step in seeing our way through the pandemic," said Dr Buddy Creech, a pediatric infectious disease expert at the Vanderbilt University Medical Centre in Nashville, Tennessee.

"By extending the age groups that can receive vaccine, we can continue our efforts to protect those that are most vulnerable: older adults as well as adults and teenagers with underlying medical conditions," said Creech, who was not involved in the Pfizer research.

The FDA's review process will probably take several weeks, provided the data look good and are consistent with what was seen in adults, said Dr Jesse Goodman, director of the Centre on Medical Product Access, Safety and Stewardship at Georgetown University and former FDA chief scientist.

Norman Baylor, president and chief executive of Biologics Consulting and former director of the FDA's Office of Vaccine Research and Review, agreed.

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