Pfizer asks FDA to clear its Covid-19 vaccine for children aged 5 to 11

The trial included 2,268 children, two-thirds of whom received two doses of the vaccine three weeks apart. The other volunteers were inj...


The trial included 2,268 children, two-thirds of whom received two doses of the vaccine three weeks apart. The other volunteers were injected with two doses of saltwater placebo. Regulators during the summer requested that the trial size be enlarged to 3,000 children.

During a virtual panel on Covid-19 last week, Norman Baylor, the former director of the Food and Drug Administration’s office of vaccines, said the number of participants in Pfizer’s pediatric study was noticeably low. The adult trial involved approximately 44,000 people.

“This raises the question of size, given what we have for adults: would we expect more for the pediatric population? ” he said. “They might think, ‘Well, we know the vaccine is safe, because look at how many people we’ve had in adults. But as we know, things can change in this pediatric population. “

The Pfizer-BioNTech and Moderna vaccines have been linked to increased risks of myocarditis or inflammation of the heart muscle; and pericarditis, inflammation of the lining around the heart, especially in younger men. In August, the Food and Drug Administration Pfizer-BioNTech vaccine analysis published results who used a US health care demands database and found that the risk of disease in vaccinated 16- and 17-year-old boys was as high as 1 in 5,000.

The cases in the database were not confirmed, but they were considered a reasonable estimate of possible risk, the agency wrote.

A lower dose of the vaccine for children may alleviate these concerns.

Officials from several countries have recommended a single dose Pfizer-BioNTech vaccine for children 12 years of age and older, which would provide partial protection against the virus, but without the potential effects seen occasionally after two doses. Sweden and Denmark have joined these countries, announcing on Wednesday that teens should only receive a single dose of the Moderna vaccine.

Amy Schoenfeld Walker contributed reports.

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Newsrust - US Top News: Pfizer asks FDA to clear its Covid-19 vaccine for children aged 5 to 11
Pfizer asks FDA to clear its Covid-19 vaccine for children aged 5 to 11
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