The sBLA includes updated longer-term follow-up data from the companies pivotal Phase 3 clinical trial of 2,228 participants 12 through 15 years of age. In the trial, a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (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 intend to file these data with the European Medicines Agency (EMA) and other regulatory authorities around the world in the coming weeks. The Pfizer-BioNTech COVID-19 Vaccine is currently available for use among individuals 12 through 15 years of age as part of an Emergency Use Authorization (EUA), which the U.S. Food and Drug Administration (FDA) authorized on May 10, 2021. This is the only COVID-19 vaccine authorized for this age group in the U.S. The vaccine is also currently available for individuals 12 through 15 years of age in the European Union under a Conditional Marketing Authorization.
COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
U.S. Indication & Authorized Use HOW IS THE VACCINE GIVEN?
The vaccine will be given as an injection into the muscle.
Primary Series:
In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 12 years of age and older, a third primary series dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.
Booster Dose:
- A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series to individuals 16 years of age and older
- A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose
WHAT IS THE INDICATION AND AUTHORIZED USE?
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
- a 2-dose primary series to individuals 5 years of age and older
- a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
- a single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
- a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
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