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The FDA Could Soon Review the Pfizer Vaccine for Children Ages 5 to 11

After a long period of unimaginable COVID-19 stress for parents of children under age 12, there’s finally a light on the horizon. On Monday, Pfizer-BioNTech announced that its vaccine had been shown to be “safe and highly effective” in young children ages 5 to 11.

The next steps for getting those kids vaccinated include Pfizer and BioNTech applying for a FDA regulatory review and the federal agency authorizing use of the vaccine for that purpose; if all that happens, millions of children could be vaccinated before Halloween, bringing some measure of security to families who have been racked with worry ever since pediatric COVID-19 cases began skyrocketing earlier this year. The news also brings a sense of relief to parents who have been crossing their fingers for a less disruptive school year in 2021–22, as well as the millions of women who have left the workforce since the pandemic began due to the unpredictabilities of school and child-care systems

Bill Gruber, a senior vice president at Pfizer and a pediatrician, told The New York Times that trial results for children under 5 are not expected until fall of this year at the absolute earliest, meaning that parents of babies, toddlers, and preschool-age children will have to live with the uncertainty of not knowing whether their families are protected for a while longer. Still, this constitutes a major win in the U.S.’s pandemic fight, as there are more than 20 million children in this country who are between the ages of 5 and 11. Hopefully, the FDA will act swiftly to protect them from the virus.


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