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Pfizer submits COVID-19 vaccine data to FDA for children aged 5 to 11

Pfizer has submitted initial trial data to the US Food and Drug Administration to clear its COVID-19 vaccine in children aged 5 to 11, the company said Tuesday.

The drugmaker said in a statement it would make a formal request with US regulators for emergency use in the coming weeks.

The vaccine is already authorized for emergency use in those aged 12 to 15 and is fully approved for anyone over the age of 16.

The Pfizer vaccine was authorized for children aged 12 to 15 about a month after the company filed for authorization.

This means younger children aged 5 to 11 could start receiving their shots by late October if the same timeline is followed.

Pfizer revealed last week that its vaccine, created with German partner BioNTech, has been found to be safe and effective in children aged 5 to 11.

Pfizer is testing the vaccine in children aged 2 to 5, as well as those aged 6 months to 2 years
JEFF KOWALSKY/AFP via Getty Images

The vaccine generated a “robust” immune response in young children during clinical trials, according to the company.

Pfizer said the 2,268 children participating in the trial were given two doses of the vaccine 21 days apart and they had comparable antibody results to teens that were included in an earlier trial.

Pfizer has submitted the initial COVID-19 vaccine data for the 5 to 11-year-old age range to the FDA for approval.JEFF KOWALSKY/AFP via Getty Images

The young children were given a much lower dose — about a third of the amount that is used for teens and adults.

Pfizer said of the 2,268 children who participated in the trial and given two doses of the vaccine 21 days apart had comparable antibody results to teens with the normal COVID-19 vaccine.
Pfizer said of the 2,268 children who participated in the trial and given two doses of the vaccine 21 days apart had comparable antibody results to teens with the normal COVID-19 vaccine.
PATRICK T. FALLON/AFP via Getty Images

The side effects of the vaccine, including sore arms, fever or achiness, were generally comparable to those found in a trial of those aged 16 to 25 years.

Pfizer is testing the vaccine in children aged 2 to 5, as well as those aged 6 months to 2 years.

Moderna’s vaccine hasn’t yet been authorized for use in adolescents in the US.

With Post wires

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