Pfizer and BioNTech to Supply New Zealand with 1.5 million doses of their BNT162 mRNA-based Vaccine Candidate Against SARS-CoV-2

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Pfizer and BioNTech to Supply New Zealand with 1.5 million doses of their BNT162 mRNA-based Vaccine Candidate Against SARS-CoV-2

Media release from Pfizer and BioNTech
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• Supply of 1.5 million doses to be provided over the course of 2021, subject to Medsafe approval

• Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the COVID-19 pandemic

• Pfizer and BioNTech began a Phase 2/3 safety and efficacy trial and assuming positive data, plan to initiate regulatory applications in the fourth quarter of 2020 and manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021

Pfizer New Zealand and BioNTech SE today announced an agreement with the Ministry of Health in New Zealand to supply 1.5 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval, in 2021.

Financial details of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses. As requested by the Government of New Zealand, deliveries are planned in 2021,

subject to clinical success and local regulatory approval.

“We are deeply honored to work with the New Zealand government and to marshal our scientific and manufacturing resources toward our shared goal of bringing a potential COVID-19 vaccine to the New Zealand people as quickly as possible,” said Anne Harris, Pfizer New Zealand Country Manager.

“In the face of this global health crisis, Pfizer’s purpose – breakthroughs that change patients’ lives – has taken on an even greater urgency. Our hope is that, subject to clinical and regulatory success, our vaccine will help make this happen.”

“I would like to thank the New Zealand government for its support and putting trust in our ability to develop a vaccine that, we believe, has the potential to help address this global pandemic threat. Our goal remains to create a global supply of a safe and effective COVID-19 vaccine for many people around the world, as quickly as we can,” said Sean Marett, Chief Business and Chief Commercial Officer at BioNTech.

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 aims to provide governments, including those in the emerging markets, with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers across the world.

About the BNT162 Candidate

The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. In July, two of the companies’ four investigational vaccine candidates – BNT162b1 and BNT162b2 – received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies.

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.

About the Phase 2/3 Study

In the late-stage trial, the companies will study a 30 micrograms dose level in a 2-dose regimen. In September, Pfizer submitted an amended protocol to the FDA for the Phase 3 pivotal trial to expand recruitment from 30,000 to approximately 44,000 participants that allows for the enrollment of new populations and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.

Based on current infection rates, we continue to expect that a readout on efficacy for the trial’s primary endpoint could be as early as the end of October. It is expected to include approximately 120 sites globally including in regions with significant expected SARS-CoV-2 transmission.

Assuming clinical success, Pfizer and BioNTech plan to initiate regulatory applications for BNT162b2 in the fourth quarter of 2020 and, if regulatory authorization or approval is obtained, 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.

The BNT162 vaccine candidate is not currently approved for distribution anywhere in the world. Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.

About Pfizer New Zealand: Breakthroughs That Change Patients’ LivesTM

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines. Our diversified global health care portfolio includes biologic and small molecule medicines and vaccines.

Consistent with our responsibility as one of the world's leading biopharmaceutical companies, we also collaborate with healthcare providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. For more information please visit: www.pfizer.co.nz

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