Pfizer and BioNTech announced on Monday that their jointly developed coronavirus vaccine offered strong long-term protection against COVID-19 in adolescents aged 12 to 15, the companies said, with full regulatory approval in the US and around the world. Will support planned submissions for
Pfizer said the two doses of the vaccine were 100% effective against COVID-19, measured seven days to four months after the second shot.
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 lead to submissions to the U.S. Food and Drug Administration and other global regulators for full regulatory approval. will be used to support approval in this age group, the companies said.
The trial saw no serious safety concerns and side effects were in line with other data reported for the vaccine, Pfizer said, including injection site pain, fever, fatigue and chills.
Pfizer CEO Albert Bourla said the findings are “particularly important” given the rising rates of COVID-19 in this age group in some regions, while the pace of the vaccine is slow.