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Pfizer submits initial COVID vaccine trial data to FDA for children aged 5-11

Pharmaceutical company files information from study involving over 2,000 children; says not yet requesting emergency use authorization, but expected to do so in weeks

An Israeli receives the COVID-19 vaccine on September 20, 2021 in Jerusalem (Olivier Fitoussi/Flash90)
An Israeli receives the COVID-19 vaccine on September 20, 2021 in Jerusalem (Olivier Fitoussi/Flash90)

Pfizer on Tuesday said it submitted initial trial data on vaccinating children aged 5 to 11 against the coronavirus to United States regulators.

The company said it was not yet seeking emergency use authorization for the Pfizer-BioNTech vaccine, but could do so in the coming weeks.

The pharma giant said it was also planning to submit to the European Medicines Agency (EMA) and other regulatory authorities.

When the request is made, the US Food and Drug Administration (FDA) is expected to take at least a number of weeks to examine the data before granting emergency use authorization.

Pfizer said that it studied a vaccine with a much lower dose — a third of the amount that’s in each shot given now — in 2,268 kindergartners and elementary school-aged kids.

The FDA required what is called an immune “bridging” study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults.

Israelis receive their dose of the COVID-19 vaccine at a Clalit health care maintenance organization, on September 09, 2021, in Jerusalem. (Olivier Fitoussi/Flash90)

Pfizer said last week that its vaccine works for that age group and that after children age 5 to 11 got their second dose during testing, they developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots.

Pfizer CEO Albert Bourla said earlier this week that if the Food and Drug Administration approves the company’s application, “we will be ready with our manufacturing to provide this new formulation of the vaccine.”

Pfizer CEO Albert Bourla speaks at a Pfizer manufacturing site, in Portage, Michigan, February 19, 2021. (Evan Vucci/AP)

While kids are at lower risk of severe illness or death than older people, more than 5 million children in the US have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have risen dramatically as the Delta variant swept through the country.

Pfizer also confirmed Tuesday that initial results from trials for children under the age of 5 were expected by the end of the year. The trials for that cohort as well as children under the age of 12 were held in the United States, Finland, Poland, and Spain.

Following Pfizer’s announcement on the effectiveness of its vaccine in young children, a senior Israeli health official said last week that the country will wait for FDA approval before giving COVID-19 vaccinations to younger children, as it did before it starting vaccinating those aged 12-16.

“We are waiting for a regulatory approval,” Dr. Sharon Alroy-Preis, the ministry’s chief of public health services, told Army Radio.

Alroy-Preis said that the matter of vaccinating young children was different from the third booster vaccine shot, which Israel started administering before the FDA even discussed the matter, because “we saw from the data that the vaccine’s protection was waning.”

In July, Israel began to administer coronavirus vaccines to children aged 5-11 who have serious background illnesses that could make them more vulnerable to COVID-19.

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