Pfizer and BioNTech SE have concluded exploratory talks with the European Commission for a proposed supply of 200 million doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2 to European Union (EU) Member States, with an option for further 100 million doses. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization. The companies will now enter into contract negotiations with the European Commission.
 
The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. Vaccine doses for Europe would be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. If regulatory approval for the BNT162b2 vaccine candidate is received, the European Commission would lead the process for allocation of the vaccine doses among the 27 EU Member States.
 
“Pfizer and BioNTech’s anticipated agreement with the European Commission is an important step forward in our shared goal to have millions of doses of a vaccine against COVID-19 available for vulnerable populations before the end of the year. We would like to thank the European Commission for its commitment and confidence in our development efforts,” said Albert Bourla, chairman and chief executive officer, Pfizer. “We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”
 
Ugur Sahin, chief executive officer and co-founder, BioNTech, said, “As a company founded in the heart of Europe, we are pleased to have concluded exploratory discussions with the European Commission, which would be our largest initial order to date. Our aim is to develop a safe and effective vaccine to contribute to bringing this pandemic to an end in Europe and across the world. Today’s decision is a further illustration of how collaboration and solidarity can help address a global health crisis as an international community.”
 
In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that, using a range of technology platforms, aims to provide governments, including those in the emerging markets, with early access to a large portfolio of COVID-19 candidate vaccines produced by multiple manufacturers across the world.
 
The BNT162 Vaccine Candidate Program
 
The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. Two of the companies’ four investigational vaccine candidates – BNT162b1 and BNT162b2 – received Fast Track designation from the U.S. Food and Drug Administration (FDA), based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. and Germany as well as animal immunogenicity studies. During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response.
 
On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies.
 
The Phase 2/3 Study
 
In the late-stage trial, Pfizer and BioNTech are studying a 30µg dose level in a 2-dose regimen among up to 30,000 participants aged 18 to 85 years. The companies have selected approximately 120 sites globally, including those in regions with significant expected SARS-CoV-2 transmission, and are working to reach a diverse population and enroll those volunteers at increased risk for the infection with the virus. The Phase 2/3 trial enrollment to date has exceeded 25,000 participants with a second dose underway. Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021. To meet those anticipated quantities and milestones, the companies have produced sufficient supply for their 30,000 participant Phase 2/3 clinical trial and have begun to produce and stockpile their pandemic supply.