Pfizer and BioNTech SE submit updated longer-term follow-up data of Comirnaty for COVID 19 in adolescents 12 through 15 years of age to EMA and FDA.

In the trial, a two-dose series of Comirnaty (30-µg per dose) was 100% effective (95% confidence interval [CI, 87.5, 100.0]) against COVID-19, measured seven days through over four months after the second dose. Among 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with SARS-CoV-2, all cases of COVID-19 were in the placebo group (n=1,129) and no cases were in the Pfizer-BioNTech vaccine group (n=1,131). The adverse event profile was generally consistent with other clinical safety data for the vaccine, with a favorable safety profile observed in individuals with at least 6 months of safety follow-up after the second dose. Pfizer and BioNTech have also submitted these data to the FDA. The data will be filed with other regulatory authorities in the coming weeks.