Pfizer asks for coronavirus vaccine authorisation for 12-15 year in United States

By
AFP
A man receives a dose of the Pfizer/BioNTech Covid-19 vaccine at a vaccination centre set up at the exhibition hall in Nantes, western France, on April 9, 2021. — AFP

  • Pfizer's request to FDA in US comes after Phase 3 clinical trials of the vaccine.
  • Their clinical in 12-15-year-olds were 100% effective in warding off the disease.
  • For now, the vaccine has emergency authorization for use in people 16 and older.


Pfizer-BioNTech on Friday asked the US government for authorisation to use their coronavirus vaccine on 12-15-year-olds in the country.

The companies said in a statement that they plan to make similar requests of other regulatory authorities worldwide in the coming days.

Their request to the Food and Drug Administration in the US comes after Phase 3 clinical trials of the Pfizer vaccine in 12-15-year-olds were 100% effective in warding off the disease, according to the companies.

In late March they published the results of trials carried out with 2,260 adolescents in the US who the companies said showed "robust antibody responses."

The vaccine was "well tolerated with side effects generally consistent with those observed in participants 16 to 25 years of age," the companies said Friday.

For now, the vaccine has emergency authorization for use in people 16 and older.

Children are less likely to develop severe COVID-19 so vaccinating them has been less of a priority than getting older people inoculated.

The BioNTech/Pfizer shot is based on novel mRNA technology and was the first COVID-19 vaccine to be approved in the West late last year.