Pfizer-BioNTech COVID-19 Vaccine Trial Overview
Our Path to Developing an Investigational COVID-19 Vaccine
In the fight against COVID-19, a vaccine is a critical part of addressing the global health crisis by decreasing rates of infection, disease and death worldwide. Pfizer and BioNTech leveraged decades of scientific expertise to design and execute a rigorous Phase 3 clinical trial program to make our investigational COVID-19 vaccine available as quickly and safely as possible.
The landmark Phase 3 clinical trial began in late July 2020, recruiting participants aged 12 and over, and completed enrollment of 46,331 participants in January 2021. On December 11, 2020, the U.S. Food and Drug Administration (FDA) authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use.
The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet at www.cvdvaccine.com.
Developing an investigational breakthrough vaccine to help prevent COVID-19 is only possible through the dedicated work of thousands of individuals and those who volunteer to take part in research. We are grateful to each of 153 clinical trial investigators and their study teams who are partnering with us in this effort and to all of the participants who volunteered to help make a difference for society. Participants 16 years and older that originally received the placebo have the option to receive the investigational vaccine while staying in the study through our Vaccine Transition Option. Vaccine doses for placebo recipients have been secured, and our aim is that that all participants 16 years and older who received the placebo will have the opportunity to receive their first dose of the investigational vaccine within the study by March 1, 2021, if they choose.