Pfizer seeks Covid-19 vaccine approval for 12 to 15 year olds in US
Source : AFP
Washington: Pfizer-BioNTech asked for authorization Friday to use their Covid-19 vaccine on 12-15 year olds in the United States.
The companies said in a statement that they plan to make similar requests of other regulatory authorities worldwide in 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 pc 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 anti-body responses."
The vaccine was "well tolerated with side effects generally consistent with those observed in participants 16 to 25 years of age," 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 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.