Pfizer Formally Calls on FDA to Green Light Vaccine for Children Under 12

NEW YORK – Pfizer on Thursday asked the U.S. government to authorize the use of its COVID-19 vaccine in children aged 5 to 11 – and if regulators agree, injections could start within weeks .

Many parents and pediatricians are calling for protection for children under 12, the current age limit for the vaccine manufactured by Pfizer and its German partner BioNTech. Not only can young people get seriously ill at times, but keeping them in school can be a challenge with the coronavirus still raging in poorly vaccinated communities.

Pfizer announced in a tweet that it had officially filed its claim with the Food and Drug Administration.

Now the FDA will need to decide if there is enough evidence that the injections are safe and will work for young children as they do for adolescents and adults. A group of independent experts will publicly debate the evidence on October 26.

A big change: Pfizer says its research shows that the youngest should get one-third of the dose now given to everyone. After their second dose, children aged 5 to 11 developed anti-virus antibody levels as strong as adolescents and young adults receive regular strength injections.

While children are at lower risk of serious illness or death than the elderly, COVID-19 sometimes kills children and cases among young people have skyrocketed as the extra-contagious delta variant swept the country

“It makes me very happy to help other children get vaccinated,” said Sebastian Prybol, 8, of Raleigh, North Carolina. He is enrolled in the Pfizer study at Duke University and is not yet sure whether he received the vaccine or sham injections.

“We want to make sure it’s absolutely safe for them,” Sebastian’s mother Britni Prybol said. But she said she would be “happy” if the FDA cleared the vaccine.

Pfizer studied the lowest dose in 2,268 volunteers aged 5 to 11 and said there were no serious side effects. The study is not large enough to detect extremely rare side effects, such as heart inflammation that sometimes occurs after the second dose of the regular strength vaccine, mostly in young men.

If the FDA allows emergency use of doses for children, there is another hurdle before vaccinations in this age group can begin. Counselors from the Centers for Disease Control and Prevention will decide whether to recommend injections for young people, and the CDC will make a final decision.

To avoid dosage confusion, Pfizer plans to ship specially labeled vials for pediatric use containing the lower dose.

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PA reporter Emma H. ​​Tobin contributed to this report.

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The Associated Press’s Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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