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FDA approves Pfizer COVID-19 vaccine for children ages 5 to 11

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FDA approves Pfizer COVID-19 vaccine for children ages 5 to 11

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Food and Drug Administration approved Pfizer-BioNTech’s COVID-19 vaccine for children ages 5 to 11, paving the way for the vaccination of 28 million children in the United States

The federal agency announced its approval on an emergency use basis on Friday. The Centers for Disease Control and Prevention’s vaccine advisory committee will then meet to review the FDA’s decision on November 2-3. He should recommend it soon after.

The FDA’s move comes after an agency advisory committee unanimously ruled that the vaccine’s benefits for children outweigh the potential risks.

“Vaccinating young children against COVID-19 will bring us closer to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock said in a press release. “Our comprehensive and rigorous evaluation of the vaccine safety and efficacy data should help assure parents and guardians that this vaccine meets our high standards.”

Pfizer’s vaccine had previously been approved for children ages 12 to 15 in emergencies, an approval that was given in May.

Pfizer said its smaller, pediatric-sized coronavirus vaccine is nearly 91% effective in preventing symptomatic infections in children aged 5 to 11. The most commonly reported side effects were fatigue, headache, muscle pain, and chills, which are similar side effects documented in older children and adults.

Pfizer’s vaccine requires two doses given three weeks apart. It then takes two weeks for full protection to kick in.

The White House said it purchased enough doses, along with smaller, child-sized needles to immunize all children aged 5 to 11 in the country.

“The US Department of Health and Human Services is working hand-in-hand with states to make this vaccine supply available to communities across the country as quickly as possible,” the White House said last week.

This is a developing story. Please check for updates.


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