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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 its Covid-19 vaccine provides 100% protection in teens 12-15

AFP via Getty Images Key Facts 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.

Key Background The Pfizer-BioNTech shot was approved for adolescents ages 12-15 on an emergency basis in mid-May. While children and teenagers have a much lower chance of developing severe illness or dying from Covid-19, they can and do develop life threatening illness and die from Covid-19 and officials and experts hailed the shot’s emergency authorization as a way of tackling soaring infections and hospitalizations among children as the delta variant spread across the country. Vaccination would also make the return to school safer come fall, though it introduced a complicating factor as to whether schools would mandate the shot. While all states have the power to require vaccination among students attending school—many do for diseases like polio and measles—few have started to grapple with mandatory Covid-19 vaccination. Full authorization could change this, however, and the only state mandate for vaccination for K-12 students—California—is contingent on FDA approval.

Big Number 9.9 million. That’s how many teens aged 12-15 have already received at least one shot of the Pfizer-BioNTech vaccine, according to CDC data, nearly 60% of some 17 million who are eligible. Around 8.2 million are fully vaccinated, almost half.