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Pfizer hopes to get approved to vaccinate 12-year-olds by fall

Published: Apr. 7, 2021 at 5:36 PM CDT
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GREEN BAY, Wis. (WBAY) - The Pfizer vaccine is the only COVID-19 shot approved for those age 16 and older, but it could soon be approved for kids as young as 12.

Pfizer’s COVID-19 vaccine was the first to get Emergency Use Authorization from the Food and Drug Administration last year, 1.6 million doses already administered to Wisconsinites.

Now researchers have set their sights on a new population.

“Once safety is found in adults then we can look at children,” said Dr. Donald Beno, a pediatrician with Aurora BayCare Medical Center.

Pfizer just announced its findings from a third-phase study involving 12 to 15-year-olds. Of the 2,260 patients involved, half of them got the placebo or no vaccine, while the other half got the vaccine.

“In the vaccine group, 100 percent were able to prevent covid completely. In the placebo group, 18 got covid without having any vaccine,” said Dr. Beno.

Dr. Beno said the side effects were basically the same as adults.

“So mild to moderate headache, muscle aches, fatigue, low-grade fever and that was seen in both children and adults,” said Dr. Beno.

Why vaccinate children if they are not considered a high-risk group?

“Children can definitely get sick with this,” said Dr. Beno.

Dr. Beno said he’s seen a number of COVID-19 cases in kids in Green Bay, some have resulted in multisystem inflammatory syndrome (MIS-C).

“One of my own patients has heart damage that may be permanent and may require significant treatment in the future because of it,” said Dr. Beno.

Research has also shown that kids can spread the virus to adults. That is why Dr. Beno said this is good news for the future as we inch closer to herd immunity because kids are a large portion of the population.

“That is why we want to start the immunization project lower and lower,” said Dr. Beno. “Hopefully in the not-so-distant future we will start immunizing 12 years and up as well.

Albert Bourla, Chairman and Chief Executive Officer of Pfizer, made this statement on its website: “We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15. We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”

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