Children take part in vaccine study as Pfizer seeks FDA approval

Pfizer Inc and BioNTech have asked U.S. regulators to authorize emergency use of their COVID-19 vaccine for children ages 5 to 11, a group for whom no shot is currently allowed, Pfizer said on Thursday (October 07), Reuters reported.

A trial to test vaccine safety on children took place at Duke University School of Medicine. Two of the children who took part, were 7 year old Lydia and her sister, 5 year old Bridgette.

Both of the girls were calm as they received their vaccinations, although Bridgette instructed her father to hold her hand, read the report.

The U.S. Food and Drug Administration has set a date of Oct. 26 for its panel of outside advisers to meet and discuss Pfiizer’s application, making it possible for children in this age group – numbering around 28 million – to begin receiving the two-dose Pfizer/BioNTech vaccine shortly afterward.

The vaccine already has won U.S. emergency use authorization in teens ages 12 to 15 and is fully approved by regulators for people ages 16 and up.

The Pfizer/BioNTech vaccine is one of three in use in the United States, along with the two-dose Moderna vaccine and the single-dose Johnson & Johnson version, neither of which has won full regulatory approval for any age group.

A rapid authorization of the Pfizer/BioNTech vaccine in young kids could help mitigate a potential surge of cases in the coming weeks and months, with schools open nationwide and colder weather driving activities indoors. If given regulatory authorization, the two-dose Pfizer/BioNTech vaccine would become the first COVID-19 shot made available to children 5 to 11 in the United States, Reuters reported.