Pfizer submits trial data for vaccines of younger children photo from NPR
Children

Pfizer submits trial data for vaccines of younger children

Sep 29, 2021, 7:31 AM
Rose De La Cruz

Rose De La Cruz

Writer/Columnist

A decision on the Covid-19 vaccine's use in younger children is eagerly awaited by millions of Americans as coronavirus infections have soared in children to hit their highest point in early September, according to data from the American Academy of Pediatrics.

Pfizer and BioNTech on Tuesday (September 28) submitted initial trial data for their vaccine for children 5 to 11 years old as they said they would formally request US regulators for emergency use in the coming weeks.

The US Food and Drug Administration (FDA) said earlier this month it would look to complete its data review for this age group as quickly as possible, likely in a matter of weeks rather than months.

That could mean an authorization of the shot for children by the end of October, sources have told Reuters.

A decision on the vaccine's use in younger children is eagerly awaited by millions of Americans as coronavirus infections have soared in children to hit their highest point in early September, according to data from the American Academy of Pediatrics.

The vaccine, which is already authorized for 12 to 15 years old and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said last September 20.

The Pfizer-BioNTech vaccine was authorized for the 12 to 15 age group roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October.

Rapid authorization

A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.

While children are less susceptible to severe Covid-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness.

The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities. They also plan to submit data from the full late-stage trial for scientific peer-reviewed publication.

The FDA was not immediately available for comment.

Matching results

Data from the companies' trial showed the two-shot vaccine generated an immune response in children that matched what was previously observed in 16 to 25 years old. The safety profile was also comparable to the older age group, Pfizer said.

The drugmakers are also testing the vaccine in children aged two to five and those aged six months to two years, with data expected in the fourth quarter.

Moderna's Covid-19 vaccine is not yet authorized for use in adolescents in the United States, while it has gained authorization for that age group in Europe.

Both the Pfizer and Moderna vaccines have been linked by regulators to rare cases of heart inflammation in adolescents and young adults, particularly young men. Pfizer said they did not see any instances of heart inflammation in the trial participants.

Tags: #Covid19, #Covid19vaccine, #minors, #sideeffects, #Pfizer, #Moderna


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