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.

Developing the Pfizer-BioNTech COVID-19 vaccine is only possible through the dedicated work of thousands of individuals and those who volunteer to take part in research. We are grateful to 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 volunteer to help make a difference for society. Vaccine doses for placebo recipients in our studies have been secured. To date, all participants 16 years and older in our landmark trial have been offered the opportunity to receive the vaccine. 

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.

Development Milestones

February 25, 2021

Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants

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December 21, 2020 - 2 PM

Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine

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December 21, 2020 - 9 AM

Pfizer and BioNTech Receive CHMP Positive Opinion for their COVID-19 Vaccine

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December 11, 2020

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

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December 10, 2020

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

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December 2, 2020

Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19

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November 20, 2020

Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine

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November 18, 2020

Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary and Secondary Efficacy Endpoints

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November 9, 2020

Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study

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September 15, 2020

Pipeline Advances and COVID-19 Vaccine Candidate Updates

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September 12, 2020

Proposal to Expand Clinical Trial Announced

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September 9, 2020

Data from Preclinical Studies of Vaccine Candidate

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September 8, 2020

Biopharma Leaders Unite to Stand with Science

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August 20, 2020

Positive Early Data from Phase 1/2 Study of Lead Vaccine Candidate Announced

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August 12, 2020

Peer-Reviewed Phase 1/2 Data Published Online in the Journal Nature

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July 27, 2020

Lead Covid-19 Vaccine Candidate Selected and Global Phase 2/3 Clinical Study Begins

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July 20, 2020

Early Positive Data from Ongoing Phase 1/2 Clinical Trial in Germany Announced

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July 13, 2020

Pfizer and BioNTech Granted Fast Track Designation

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July 1, 2020

Early Positive Data from Ongoing Phase 1/2 Clinical Trial in the U.S. Announced

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May 5, 2020

Pfizer and BioNTech Dose First Participants in the U.S.

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April 29, 2020

Testing of Vaccine Candidates in Humans Begins in Germany

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April 22, 2020

Regulatory Approval from German Authority to Begin Trial

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April 9, 2020

Pfizer and BioNTech Announce Further Details on Collaboration

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March 17, 2020

Pfizer and BioNTech Announce Plans to Co-Develop a Potential COVID-19 Vaccine

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March 13, 2020

Pfizer CEO Albert Bourla States 5-Point Plan to Battle COVID-19

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March 11, 2020

The World Health Organization (WHO) Declares the COVID-19 Outbreak a Global Pandemic

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August 16, 2018

Pfizer and BioNTech Establish Partnership to Develop mRNA Vaccines

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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”.