Pfizer says it plans to ask for FDA approval of its COVID-19 vaccine for children ages five to 11 by fall

July 4, 2021 in News, Video by RBN Staff

  • Pfizer Inc and its German partner BioNTech SE plan to ask for FDA emergency use authorization of its COVID-19 vaccine in children under age 12 by fall 
  • Dr Alejandra Gurtman, a Pfizer executive, said the company would apply for approval in kids aged 5-11 by September or October and younger kids soon after 
  • The trial is examining the safety and efficacy of the vaccine in 4,500 children at 90 sites in the U.S., Finland, Poland and Spain
  • Parents and doctors have been debating about whether or not to vaccine children because, although they do fall sick, they make up 0.1% of COVID deaths

 

 

Pfizer Inc and its German partner BioNTech SE plan to ask the U.S. Food and Drug Administration (FDA) to approve their COVID-19 vaccine in children aged 11 and younger by fall.

The vaccine was authorized for emergency use by the FDA in late December 2020 for Americans aged 16 and older and in May 2021 for those aged 12 and older.

Dr Alejandra Gurtman, vice president of vaccine clinical research and development at Pfizer, appeared at a virtual symposium on Wednesday held by Johns Hopkins University and the University of Washington to discuss details about pediatric vaccine trials.

She said the companies are planning to first ask for approval in kids between ages five and 11, and then for youngsters below age five.

‘We are planning for emergency use authorization submission for the older age group, that is the five to 11, in September [or] October of this year, and the younger group to follow soon thereafter,’ she said.

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Pfizer Inc and its German partner BioNTech SE plan to ask for FDA emergency use authorization of its COVID-19 vaccine in children under age 12 by fall. Pictured: A mother holds her young child as she is vaccinated in Pfizer's clinical trial in Jefferson, Louisiana, June 2021

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Pfizer Inc and its German partner BioNTech SE plan to ask for FDA emergency use authorization of its COVID-19 vaccine in children under age 12 by fall. Pictured: A mother holds her young child as she is vaccinated in Pfizer’s clinical trial in Jefferson, Louisiana, June 2021

Dr Alejandra Gurtman, a Pfizer executive, said at a symposium on Wednesday that the company would apply for approval in kids aged 5-11 by September or October and younger kids soon after (above)

Dr Alejandra Gurtman, a Pfizer executive, said at a symposium on Wednesday that the company would apply for approval in kids aged 5-11 by September or October and younger kids soon after (above)

Pfizer plans to have COVID-19 vaccine eligible for kids under 12 by fall

 The pediatric trial was launched in March 2021 with the two-shot vaccine being tested in 4,500 participants.

Children have been split into three age groups: ages six months to two years, ages two to five years and ages five to 11.

Kids between ages six months and five years are being given three microgram doses and those between ages five and 11 are being given 10 microgram doses.

For comparison, people above age 12 who receive the vaccine are given 30 microgram doses.

The trial is currently being conducted at 90 centers in the U.S., Finland, Poland and Spain, Gurtman said at the symposium.

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