Pfizer-BioNTech COVID-19 Vaccine Development Program
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 the Pfizer-BioNTech COVID-19 Vaccine available as quickly and safely as possible. Today, we are continuing to evaluate data from this landmark trial, while also initiating new trials in special populations, such as pregnant women and children under 12. We are also planning studies to assess the potential need for boosters or modified vaccine in the event that newly emerging variants evade the protection offered by the existing vaccine.
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.
About Our Landmark Trial
Studies in Additional Populations
Studies to Address Emerging Variants
Commitment to Safety
Participant safety is paramount to Pfizer. As with all of our trials, we are following all of the rules and regulations in place to ensure participant safety. For example, the trial protocols are reviewed by regulatory authorities and approved by ethics committees or Institutional Review Boards, which are independent committees that review the methods proposed for research. In addition, the trial’s progress is closely monitored by both Pfizer and an outside group of independent experts called a Data Monitoring Committee or DMC. Trial investigators are also responsible for monitoring participants health, and participants in the trial have regular planned follow-up visits as part of the trial.
Commitment to Diversity
We are committed to decreasing health disparities in underrepresented populations through our clinical trials. In our landmark trial, we selected investigative sites in diverse communities in the U.S. and globally that were disproportionately affected by COVID-19, to help ensure that individuals in communities that have been most impacted had the opportunity to participate. In our landmark Phase 3 study, approximately 42% of overall and 30% of U.S. participants came from diverse backgrounds. We shared with our investigative sites the importance of recruiting individuals who fully represent the racial and ethnic diversity of their communities, and we engaged patient advocacy partners and community groups to raise awareness about the importance of participation and representation. In all of our newly initiated trials, we remain committed to enrolling diverse participant populations.
Commitment to Data-Sharing
Pfizer has a longstanding commitment to ensure that access to study- and participant-level clinical trial data is available to regulators, researchers, and trial participants. We seek to provide as much data transparency as possible without jeopardizing the regulatory decision- making process, participant privacy, or intellectual property and have a process in place for data requests, utilizing an independent platform called Vivli.
We are participating in the International COVID-19 Data Alliance (ICODA) as well as TransCelerate BioPharma consortium to share study- and participant-level clinical data from our COVID-19 trials at the appropriate times after regulatory submissions.
For more information on our data sharing policies and to request data from the COVID-19 vaccine trials, please visit Data Access Requests.
Learn more about progress on our path to develop a COVID-19 vaccine.
For additional information about Pfizer, please see our filings with the U.S. Securities and Exchange Commission, including the information provided in the sections captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”.