By Robert Langreth; March 31, 2021, 6:45 AM EDT Updated on
- Company will seek to add adolescents to its FDA authorization
- Result could pave way for shots in teens before school reopens
Pfizer Inc. said its Covid-19 vaccine was 100% effective in a final-stage trial in kids ages 12 to 15, a finding that could pave the way for teens and pre-teens to get shots before the next school year.
The vaccine is already authorized in the U.S. for people ages 16 and up. Pfizer and its partner BioNTech SE said they planned to submit the data to regulators in the U.S and Europe as soon as possible, seeking to amend their vaccine authorizations to include the younger age group.
In the study of 2,260 adolescents, the vaccine produced antibodies against the Covid-19 that exceeded the level seen in vaccinated young adults, Pfizer and BioNTech said in a statement. All 18 cases of Covid-19 in the study were in adolescents who were administered a placebo, the companies said. Side effects were consistent with those experienced by people ages 16 to 25.
A Pfizer spokesperson, meanwhile, said the company is in conversations with the U.S. Food and Drug Administration on what the next steps may be. The FDA declined to comment on how quickly it might act on the data.