- Supply to be provided over the course of 2021, subject to necessary regulatory authorization
- Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the COVID-19 pandemic
Beirut, Lebanon and MAINZ, GERMANY, 18 January 2021 — Pfizer and BioNTech SE Today announced an agreement with the Ministry of Health (MOH) in Lebanon to supply their COVID-19 mRNA vaccine candidate (BNT162b2), in 2021.
Financial details of the agreement were not disclosed. As requested by the MOH in Lebanon, deliveries are planned in 2021.
“Today, we signed an agreement to import the mRNA-based vaccine developed by Pfizer and BioNTech. This step will create a leap in our journey to preserve our citizens’ and residents’ safety and health. We hope that this agreement will play a crucial role in ensuring better health and recovery of the economic sector. We also hope that this vaccine will play a larger role in completely eliminating the COVID-19 pandemic locally and globally,” HE Hamad Hassan, Health Minister in Lebanon, said.
He added: “The Ministry of Health in Lebanon will scientifically monitor the vaccine recipients for side effects as per approved global and local regulations. The vaccines will not substitute protection and prevention measures that will continue at a local level against the coronavirus.”
“We are deeply honored to work with the MOH in Lebanon and to marshal our scientific and manufacturing resources toward our shared goal of bringing a COVID-19 vaccine to the Lebanese people as quickly as possible,” said Rawad Gebrael, Pfizer Lebanon & Jordan 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 regulatory success, our vaccine will help make this happen.”
“I would like to thank the MOH in Lebanon 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 deliver 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.
Pfizer and BioNTech aim to manufacture approximately 2 billion doses globally in total by the end of 2021, assuming updated 6-dose labeling, continuous process improvements, expansion at current facilities and adding new suppliers and contract manufacturers.
The BNT162b2 vaccine candidate is not currently approved for distribution in Lebanon.
About the Study
The Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, began on July 27 and has enrolled more than 45,000 participants. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S., Germany, Turkey, South Africa, Brazil and Argentina. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people 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 care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care 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. We routinely post information that may be important to investors on our website at www.Pfizer.com.
Pfizer Disclosure Notice
The information contained in this release is as of January 17, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, the BNT162 mRNA vaccine program, an agreement with the MOH in Lebanon to supply BNT162 and other potential agreements, and modRNA candidate BNT162b2 (including qualitative assessments of available data, potential benefits, expectations for clinical trials, anticipated timing of regulatory submissions, regulatory approvals or authorizations, and anticipated manufacturing, distribution and supply), involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations upon commercialization; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in Lebanon any particular jurisdictions for BNT162b2 or any other potential vaccine candidates; whether and when any applications that may be pending or filed for BNT162b2 may be approved by particular regulatory authorities including in Lebanon, which will depend on myriad factors, including making a determination as to whether the vaccine candidate’s benefits outweigh its known risks and determination of the vaccine candidate’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine candidate’s ultra-low temperature formulation and attendant storage, distribution and administration requirements, including risks related to handling after delivery by Pfizer; the risk that we may not be able to successfully develop non-frozen formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for any potential approved vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine candidate within the projected time periods indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.