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Pfizer Inc. and BioNTech SE announced that they have entered into an agreement with the Japanese Ministry of Health, Labor and Social Affairs (MHLW) announced delivery of 120 million doses of the mRNA-based vaccine candidate BNT162 against SARS-CoV-2. Subject to regulatory approval or approval, delivery is scheduled for early 2021.
Financial details of the agreement have not been released. Contract terms were set based on the delivery schedule and the number of cans. At the request of the Japanese government, the vaccine candidate will be delivered in the first half of 2021.
“We are honored to work with the Japanese government to use our scientific resources and production capacity for our common goal of providing millions of doses of a potential vaccine candidate to the Japanese population as quickly as possible,” said Dr. Albert Bourla, Chairmann and CEO of Pfizer. “In the face of this global health crisis, Pfizer’s business purpose – Breakthroughs that change patients’ lives– get an even greater urgency. In the current difficult environment, we are proud to support Japan in its efforts to bring the world together at the 2020 Tokyo Olympics to celebrate solidarity, friendship and the power of sport as a global sign of the power of good. We hope that our vaccine candidate will contribute to this subject to regulatory approval or approval. ”
“The Olympics have brought the world together in one place for centuries and have become a symbol of the global community. With this in mind, the Tokyo Olympics could become a new symbol for all of us how all nations of the world can together overcome the pandemic. We are proud and honored that our vaccine candidate could contribute to the efforts of the Japanese government to achieve this vision, ”said Ugur Sahin, CEO and co-founder of BioNTech.
Das BNT162-Programm beruht auf BioNTechs unternehmenseigener mRNA-Technologie und wird von Pfizers Expertise zur globalen Impfstoffentwicklung und -produktion unterstützt. Das Entwicklungsprogramm von Pfizer und BioNTech evaluiert mindestens vier Impfstoffkandidaten, die jeweils eine einzigartige Kombination von mRNA-Formaten und Zielantigenen umfassen. Die BNT162-Impfstoffkandidaten befinden sich aktuell in der klinischen Entwicklung und sind in keinem Land der Welt für den Gebrauch zugelassen. Für beide Partner sind die präklinischen und klinischen Daten ein zentrales Element für alle Entscheidungen im Rahmen der Entwicklung der neuartigen Impfstoffe.
Recently, two of the four vaccine candidates in clinical development (BNT162b1 and BNT162b2) received Fast Track status from the US Food and Drug Administration (FDA). Status was granted based on preliminary data from two phase 1/2 studies currently underway in the United States and Germany and on animal immunogenicity studies.
On July 27, Pfizer and BioNTech announced that both companies had selected the BNT162b2 vaccine candidate for a phase 2/3 trial. This selection was made after extensive examination of the preclinical and clinical data from the phase 1/2 study and in consultation with the US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) and other global regulatory authorities. BNT162b2 codes for an optimized SARS-CoV-2 spike glycoprotein (S) in its full length. This protein is the target of neutralizing antibodies that are thought to inactivate the virus. In the advanced study, the companies investigated the vaccine by administering two 30 µg doses each in up to 30,000 subjects between the ages of 18 and 85.
If the clinical trials are successful, Pfizer and BioNTech plan to apply for regulatory approval in October 2020 and to produce up to 100 million doses of vaccine by the end of 2020 and over 1.3 billion doses of vaccine by the end of 2021.
In addition to agreements with governments, Pfizer and BioNTech have expressed interest in a possible delivery for the COVAX Facility. COVAX Facility was launched by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO), and aims to provide governments with early access to a broad portfolio of COVID-19 vaccine candidates, which is based on a number of different technology platforms produced by multiple manufacturers around the world.
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering the development of therapies for cancer and other serious diseases. The company combines a variety of modern therapeutic platforms and bioinformatics tools to rapidly advance the development of novel biopharmaceuticals. The diversified portfolio of oncological product candidates includes individualized therapies as well as off-the-shelf medications based on mRNA, innovative chimeric antigen receptor (CAR) T cells, bispecific checkpoint immunomodulators, targeted cancer antibodies and small molecules. Based on its extensive expertise in the development of mRNA vaccines and the company’s own manufacturing capacities, BioNTech develops not only its diverse oncology pipeline, but also collaboration partners with various mRNA vaccine candidates for a number of infectious diseases. BioNTech works side by side with globally renowned cooperation partners from the pharmaceutical industry, including Genmab, Sanofi, Bayer Animal Health, Genentech (a Roche Group company), Genevant, Fosun Pharma and Pfizer.
Further information can be found at: www.BioNTech.de .
Forward-looking statements by BioNTech
This press release contains certain forward-looking statements made by BioNTech under the 1995 Private Securities Litigation Reform Act, including but not limited to express or implied statements relating to: BioNTech’s efforts to combat the COVID-19 pandemic; the schedule for the initiation of clinical studies of BNT162 and the planned publication of data from these studies; the schedule for any emergency approvals or approvals; the possibility of entering into additional supply contracts with other jurisdictions or the COVAX facility; the potential safety and effectiveness of BNT162; the collaboration between BioNTech and Pfizer to develop a potential vaccine against COVID-19; and BioNTech’s ability to deliver the amounts of BNT162 to support clinical development and, if approved, to meet market needs, including our 2020 and 2021 production estimates. All forward-looking statements in this press release are based on BioNTech’s current expectations and estimates regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and disadvantageously from those contained or implied in these forward-looking statements. These risks and uncertainties include, but are not limited to: a competition to develop a vaccine against COVID-19; the ability, achieve comparable clinical results in larger and broader clinical trials; the ability to effectively scale our production capabilities; as well as other possible difficulties. For a discussion of these and other risks and uncertainties, see Form 20-F in the BioNTech Annual Report filed with the SEC on March 31, 2020, available on the SEC’s website atwww.sec.gov is available. All information in this press release is as of the date of publication and BioNTech is under no obligation to update this information unless required by law.
About Pfizer Inc: Breakthroughs That Change Patients’ Lives
At Pfizer, we use science and our global resources to offer people therapies that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health products, including innovative medicines and vaccines. Every day, Pfizer employees in industrialized and emerging countries work to promote general well-being, prevention, treatments and cures to deal with current serious illnesses. In line with our responsibility as one of the world’s leading innovative biopharmaceutical companies, we work with healthcare providers, governments and local communities, to support and expand access to reliable and affordable healthcare around the world. For more than 150 years we have been working to make a difference for everyone who relies on us. We routinely post information that may be important to investors on our website atwww.Pfizer.com . You can find more information about Pfizer at www.Pfizer.com , on Twitter at @Pfizer and @Pfizer News , LinkedIn , YouTube and on Facebook at Facebook.com/Pfizer .
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