Pfizer and BioNTech ask FDA to approve their Covid-19 vaccine for kids as young as 12
Pfizer and BioNTech completed their request to the Food and Drug Administration to approve their Covid-19 vaccine for children as young as 12, the companies announced Friday.
The companies submitted Phase III clinical trial data to FDA as a supplemental application for their vaccine, which is already approved for adults and children as young as 16. In the new data, their vaccine was 100 percent effective at preventing symptomatic Covid-19 in children who received the vaccine up to four months after their second dose. All children who developed Covid-19 in the trial had received the placebo.
Background: The Pfizer-BioNTech Covid-19 vaccine is the only vaccine to receive full FDA approval so far. It's also the only vaccine available for younger children. In May, FDA authorized the vaccine for children as young as 12; it later authorized the vaccine for children as young as 5 in October.
What’s next: FDA will review the data and decide whether to update the vaccine’s approval.
