OUR PROGRESS IN 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 are leveraging our decades of scientific expertise and working together to make our investigational COVID-19 vaccine available as quickly and safely as possible. The Phase 3 clinical trial began in late July 2020, recruiting participants aged 12 and over. The clinical trial continues to be open for participants aged 12-15 years to enroll.
After conducting the final efficacy analysis in our Phase 3 study, the mRNA-based COVID-19 vaccine candidate met all of the study’s primary efficacy endpoints. Primary efficacy analysis demonstrated the vaccine candidate to be 95% effective against COVID-19 beginning 28 days after the first dose.
On December 11, 2020, 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 committed to diversity in our clinical trial and ensuring that individuals from communities that have been most affected by COVID-19 have the opportunity to participate.
We are grateful to each of approximately 150 clinical trial investigators and their study teams who are partnering with us in this effort and to all of the participants who have volunteered, and will volunteer, to help make a difference for society.