On Dec. 23, 2021, Pfizer and BioNTech announced that they had submitted longer-term follow-up data from the companiesﾒ pivotal Phase 3 clinical trial in 2,228 individuals 12 through 15 years of age to the European Medicines Agency (EMA) to further support the favorable safety and efficacy profile of COMIRNATY (COVID-19 mRNA vaccine) in this age group.

In the trial, a two-dose series of COMIRNATY (30-ﾵg 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.