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Pfizer and BioNTech Reach an Agreement to Supply the EU with 200 Million Doses of Their BNT162b2 mRNA-based Vaccine Candidate against COVID-19

Pfizer (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that they have reached an agreement with the European Commission to supply 200 million doses of their investigational BNT162b2 mRNA-based vaccine candidate against COVID-19 to European Union (EU) Member States, with an option for the European Commission to request an additional 100 million doses. Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization.

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Agreement provides a supply of 200 million doses and an option to request additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval

The vaccine supply for the EU will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium and based on current projections, the companies expect to produce globally up to 1.3 billion doses in 2021

Pfizer and BioNTech initiated a rolling submission to the European Medicines Agency (EMA) in October, and will continue regular and open dialogue with the EMA providing results from their ongoing Phase 3 study

Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. If the BNT162b2 vaccine candidate receives approval from the European Medicines Agency (EMA), then the European Commission will lead the process for allocation of the vaccine doses among the EU Member States who have elected to receive the vaccine as part of this agreement.

“Since the onset of the pandemic, Pfizer’s priority has been to develop a safe and effective vaccine, while simultaneously scaling up our manufacturing to deliver doses before the end of the year. This is an ambitious goal but critical to halting this global pandemic,” said Albert Bourla, Chairman and CEO, Pfizer. “Today’s finalized supply agreement with the European Commission represents the largest initial order of vaccine doses for Pfizer and BioNTech to date and a major step toward our shared goal of making a COVID-19 vaccine available to vulnerable populations.”

“As a company founded in the heart of Europe, we are looking forward to supplying millions of people upon regulatory approval. We would like to thank the Commission and the Member States for their support and trust in our COVID-19 vaccine candidate. Our aim is to develop a safe and effective vaccine to contribute to bringing this pandemic to an end. Only through joint efforts will we be able to do so,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

Pfizer and BioNTech announced the conclusion of exploratory talks with the European Commission to supply doses of the BNT162b2 vaccine candidate, if approved, on September 9, 2020. The proposed supply agreement is now final.

On November 9, 2020, Pfizer and BioNTech announced their mRNA-based vaccine candidate, BNT162b2, against COVID-19 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.

The DMC reviewed 94 cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection may be achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.

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.