Coronavirus COVID-19 Vaccine Updates

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.

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.

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 | Pfizer.