Pfizer News Filer
BREAKING: Today, we requested amendments to the U.S. Emergency Use Authorization of the Pfizer-BioNTech #COVID vaccine to expand use to adolescents 12-15 years. This request is based on data from our pivotal Phase 3 trial which demonstrated 100% efficacy and robust antibody response after vaccination. In this analysis, the vaccine was well tolerated with side effects generally consistent with those observed in participants 16-25 years of age. We plan to request similar rulings by other regulatory authorities worldwide in coming days.
Pending regulatory decision, our hope is to make the vaccine available to the 12-15-year-old age group before the start of the 2021 school year.
Learn more about this important step: https://on.pfizer.com/3wFvArj
The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the US FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent COVID-19 for use in individuals 16 years and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet at www.cvdvaccine.com