Pfizer asks FDA to clear its COVID-19 vaccine for use in kids ages 12 to 15
The request to expand emergency use comes just days after Pfizer released data demonstrating its vaccine was 100% effective and well tolerated by the younger group.
Pfizer asked the FDA to expand the authorization for its COVID-19 vaccine to include children age 12 to 15.
Pfizer has asked the US Food and Drug Administration to expand the Emergency Use Authorization for its COVID-19 vaccine to include children ages 12 to 15, the company tweeted Friday. Last week, Pfizer released clinical trial data showing the drug to be both 100% 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. Results showed that the children had overall stronger immune responses one month after the second dose when compared to adults, Pfizer said.
Pfizer was the first drugmaker cleared to distribute its COVID-19 vaccine in the US in December and is currently the only one authorized for children ages 16 and 17. While the US vaccine rollout got off to a slow start, President Joe Biden recently moved up the deadline for states to open up the vaccine for all adults to April 19, just 10 days away.
The US is currently averaging about 3 million vaccines per day, according to the White House.