Published: 10th April 2021
Pfizer asks US to clear its COVID-19 vaccine for use in kids after releasing data supporting it
The request to expand emergency use comes just days after Pfizer released data demonstrating its vaccine was 100 per cent effective and well tolerated by the younger group
Pharmaceutical companies Pfizer and BioNTech have asked the US Food and Drug Administration (FDA) to expand the Emergency Use Authorization (EUA) for its Covid-19 vaccine to include children ages 12 to 15. The request to expand emergency use comes just days after Pfizer released data demonstrating its vaccine was 100 per cent effective and well tolerated by the younger group, reports CNET.
Recently, Pfizer released clinical trial data showing the drug to be both 100 per cent effective at preventing coronavirus infections and well tolerated by the study's 1,131 adolescents who received the vaccine instead of placebo. While ongoing studies on even younger children use a reduced dose, children in the 12 to 15 age group received the same dose as adults receiving the Pfizer vaccine, the report said.
The findings indicated that the children had overall stronger immune responses one month after the second dose when compared to adults. "We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15," Albert Bourla, Chairman and Chief Executive Officer, Pfizer, had said.
The Pfizer-BioNTech jab has not been approved or licensed by the FDA, but has been authorised for emergency use by FDA under an Emergency Use Authorization to prevent Covid-19 for use in individuals 16 years of age and older.