Pfizer and BioNTech announced Monday their jointly-developed coronavirus vaccine offered strong long-term protection against Covid-19 in teenagers aged 12 to 15, data the companies said will support planned submissions for full regulatory approval in the U.S. and around the world.
Pfizer said two doses of the vaccine were 100% effective against Covid-19, measured from seven days to four months after the second shot.
The longer-term data—the first of its kind to be made public and from an analysis of a late-stage clinical trial involving 2,228 volunteers—will be used to support submissions to the U.S. Food and Drug Administration and other global regulators for full regulatory approval in this age group, the companies said.
No serious safety concerns were observed in the trial and side effects were in line with other data reported for the vaccine, Pfizer said, which include injection site pain, fever, fatigue and chills.
Pfizer CEO Albert Bourla said the findings are “especially important” given the rising rates of Covid-19 in this age group in some regions while vaccine uptake slows.