How are you monitoring the safety of trial participants?

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.

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Coronavirus COVID-19 Vaccine Update: Latest Developments

Coronavirus COVID-19 Vaccine Updates

Our Path to Developing the Pfizer-BioNTech 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 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 studying our vaccine in additional populations. We are also continuing to collect data and real-world evidence to help us understand long term immunity through ongoing booster studies, as well as the potential need for an updated vaccine in the event that newly emerging variants evade protection provided by the existing vaccine.

Developing a vaccine is only possible through the dedicated and tireless work of thousands of individuals and those who volunteer to take part in research. We are grateful for the heroic efforts of all of our clinical trial investigators and their study teams who are partnering with us in this effort and to all of the participants and their families who have and will continue to volunteer to make the world a healthier place.

Commitment to Safety
How are you monitoring the safety of trial participants?
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 our Data Request page.

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”.

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older as appropriate. The emergency uses are 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.