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Pfizer Hoping for FDA Approval for Vaccines in Over 5 Year Olds

Sep 28, 2021

– Naadiya Adams

Doctor injecting vaccination in arm

Pfizer Inc and BioNTech SE have submitted initial trial data for their vaccine in younger kids.

Ages 5-11-year-olds are high on the vaccine priority list as covid-19 infections in kids has been on the rise. The two companies are set to make a formal request with US regulators for emergency use in the coming weeks.

The US Food and Drug Administration said early in September that it would look to complete its data review for this age group as quickly as possible. By end of October, the jab could possibly have emergency approval for the over 5 age group.

According to data from the American Academy of Pediatrics, September saw a sharp increase in infections in children, its highest since the onset of the pandemic, which has sent shockwaves through parents across the United States. The FDA decision is highly anticipated by millions for this reason.

The vaccine, which is already authorized for 12 to 15-year-olds and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20.

The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities.

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