Dear Participant,
Today, Pfizer and BioNTech announced the results of the first interim analysis from our COVID-19 vaccine study. While we do not have the full study results as this is only an interim analysis, the data demonstrated that the study vaccine can prevent COVID-19 disease in adults who have not previously been diagnosed with COVID-19. This is a great victory for humanity, and one that could not have been accomplished without the almost 44,000 people who selflessly raised their hands to participate in our trial and help our scientists and clinicians advance this important breakthrough.
From your home cities in Argentina, Brazil, Germany, South Africa, Turkey and the United States, each of you has helped to bring the world one step closer to our shared goal of a potential vaccine to fight this devastating pandemic. For this, we say, “Thank You.” Breakthroughs in medicines and vaccines are only possible through the participation of clinical trial volunteers like you, and we are profoundly grateful to you and your loved ones for your efforts. You are the true heroes, and the whole world owes you a tremendous debt of gratitude.
Our work together is not done, as the study is still enrolling and carries on as planned. We will continue to collect data on the study vaccine’s safety and efficacy to confirm if it meets all of the criteria for potential approval by regulators globally. Your study doctor can provide more information and answer any questions as the trial progresses. We appreciate your continued participation and remain committed to our pledge to always make your safety and well-being our top priority.
With gratitude,
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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 12 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 here.
