Pfizer filed an application with the Food and Drug Administration on Thursday seeking emergency use authorization for its coronavirus vaccine that is approved for distribution among children age 5-11.
The FDA said it would look over the application and decide in a matter of weeks, rather than the months these types of applications normally take.
Pfizer has been conducting studies with one-third of the normal vaccine dose to see how children respond and said it has produced favorable results. However, children do not get COVID-19 as severely or frequently as adults.
"We know from our vast experience with other pediatric vaccines that children are not small adults," said acting FDA Commissioner Janet Woodcock. "We will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults.”
Parents of children under 12 have been waiting for the vaccine to become available as the children return to in-person learning in masks. Although numbers are lower for children, just under 175,000 new cases among children were found in the week ending Sept. 30, according to the American Academy of Pediatrics.
Over 100 members of Congress signed a letter in August asking the FDA for a timeline on when vaccines would be available for children.
"As transmission rates increase and schools reopen for in-person instruction, parents need to know when their kids will be able to get vaccinated," the letter stated. "We respect the scientific process and the FDA’s dedication to safety, and we applaud the swiftness with which the FDA granted an EUA for the COVID-19 vaccines for adults and adolescents. The American people need information about the status of an EUA for a vaccine safe for children, however, and we as lawmakers need to understand the FDA’s efforts to protect our youngest Americans."
An advisory committee meeting in the FDA has been set for Oct. 26, where the application will be discussed.
Pfizer is the first vaccine company to request distribution of its coronavirus vaccine for children 5-11.
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Original Author: Misty Severi
Original Location: Pfizer files for FDA approval on coronavirus vaccine for ages 5-11