FDA clears Pfizer-BioNTech's COVID-19 vaccine for use in kids 5 to 11

FDA clears Pfizer-BioNTech's COVID-19 vaccine for use in kids 5 to 11
The FDA on Friday approved the Pfizer-BioNTech vaccine against COVID-19 for children age 5 to 11 -- at a dose one-third the size given to people age 12 and older -- clearing the way for the CDC to potentially approve distribution of the shot next week. File Photo by Debbie Hill/UPI | License Photo

Oct. 29 (UPI) -- The two-dose COVID-19 vaccine from Pfizer-BioNTech has been cleared for use in children ages 5 to 11 by the Food and Drug Administration, agency officials announced Friday.

However, the Centers for Disease Control and Prevention and its Advisory Committee on Immunization Practices still need to approve the FDA's decision before doses can be distributed to young people in this age group.


The advisory committee has a meeting to discuss the issue scheduled for next week, officials said.

"As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization," acting FDA Commissioner Dr. Janet Woodcock said in a press release.

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"Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," she said.

The approval announcement was made after the FDA's Vaccines and Related Biological Products Advisory Committee voted Tuesday to greenlight the use of a smaller dose of the Pfizer-BioNTech vaccine in young children.

The low-dose version for children, which is about one-third of that given to adults, is more than 90% effective in preventing asymptomatic infection, according to the company.

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Children given the shots experienced similar side effects -- mostly redness and swelling at the injection site -- as people ages 16 to 25, meaning there is a small risk for heart inflammation following receipt of the shot, it said.

However, the benefits of vaccination in protecting against infection far outweigh the risks, officials with both the FDA and CDC have said.

COVID-19 is eighth among the 10 leading causes of death in children ages 5 to 11, as the virus has killed nearly 150 in that age group, the CDC said earlier this week.

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The Biden administration has already acquired enough vaccine doses to inoculate all of the roughly 28 million 5- to 11-year-olds nationally, the White House said last week.

Moderna's COVID-19 vaccine, which is made using a similar formulation, is currently being evaluated in clinical trials in children ages 6 to 11, according to the company.

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