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

The Food and Drug Administration has approved Pfizer-BioNTech’s COVID-19 shot for children ages 5 to 11, paving the way for 28 million children to be vaccinated in the United States

The federal agency announced its approval on an emergency basis last Friday. The Centers for Disease Control and Prevention’s vaccine advisory committee will meet next time to review the FDA’s decision on 2-3. November. It is expected to recommend it shortly after.

The FDA’s decision comes after an advisory panel to the agency unanimously decided that the benefits of the vaccine for children outweigh any potential risks.

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

Pfizer’s vaccine had already been approved for children aged 12 to 15 on an emergency basis, an approval made in May.

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

Pfizer’s vaccine requires two doses to be administered at three week intervals. It then takes two weeks for full protection to take effect.

The White House has said it has purchased enough doses, as well as smaller child-sized needles, to vaccinate all of the country’s 5- to 11-year-olds.

“The U.S. 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 soon as possible,” The White House said last week.

This is a development story. Please come back for updates.

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