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Pfizer Asks FDA to Expand COVID Vaccine Authorization for Ages 12-15



Pfizer on Friday filed a request with the Food and Drug Administration to expand use of its COVID-19 vaccine to teens ages 12 to 15.

The company and its partner BioNTech said in a joint statement they’ve requested that the U.S. agency expand the vaccine’s emergency use authorization, which the FDA originally granted late last year for people ages 16 and up.

The announcement marks a step toward possibly beginning shots in this age group before the next school year.

Last week, the companies announced its shot is safe and 100% effective in preventing the illness in kids as young as 12.

In the vaccine study of 2,260 U.S. volunteers ages 12 to 15, preliminary data showed there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 among those given dummy shots, Pfizer reported. That resulted in a vaccine efficacy of 100%, it said, adding that the shot was also well-tolerated, with side effects generally consistent with those seen in adults. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.

The company also said the vaccine, given in two doses three weeks apart, elicited a “robust” antibody response in children, exceeding those in an earlier trial of 16- to 25-year-olds. The findings have not been peer-reviewed.

Vaccinating children is crucial to ending the pandemic, public health officials and infectious disease experts say. The nation is unlikely to achieve herd immunity — when enough people in a given community have antibodies against a specific disease — until children can get vaccinated, experts say.

The companies also plan on asking European regulators to allow emergency use of the shots starting at age 12.

“We share the urgency to expand the use of our vaccine,” Pfizer CEO Albert Bourla said in a statement.

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