Novartis signs new initial agreement with BioNTech to support fill and finish of the mRNA Pfizer-BioNTech COVID-19 vaccine
- At least 24 million doses of the mRNA-based vaccine will be filled in 2022 into vials under sterile conditions at Novartis Technical Operations state-of-the-art facility in Ljubljana, Slovenia
- New agreement follows earlier supply agreement for the fill and finish of more than 50 million doses in 2021 at the Novartis Stein site in Switzerland
Novartis announced today that it has signed an initial agreement to leverage its manufacturing capacity and capabilities to address the COVID-19 pandemic by expanding its support of the fill and finish of the Pfizer-BioNTech COVID-19 vaccine. Novartis will use its sterile manufacturing facilities at its Novartis Technical Operations site in Ljubljana, Slovenia, to fill at least 24 million doses in 2022.
Under the terms of the new initial agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under sterile conditions for shipment back to BioNTech for its distribution. Subject to reaching a final agreement, Novartis plans to transfer the manufacturing process from Stein to Ljubljana site to commence the fill and finish in the first half of 2022. The facility in Ljubljana is a state-of-the-art aseptic filling operation which manufactures and supplies a broad range of aseptic products for Sandoz, a Novartis division.
This new agreement follows a first contract signed earlier this year. Novartis started filling for BioNTech at its Stein site in Switzerland in June after the European Union's drug regulator EMA approved the filling-and-finishing plant.
Novartis continues to offer its world-class capabilities to other companies to take over manufacturing activities including a variety of technologies such as mRNA production and others. The specifics will be disclosed when we conclude specific agreements.
The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of Emergency Use Authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where Emergency Use Authorizations or equivalent were initially granted are planned.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
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This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding our agreement to manufacture the Pfizer-BioNTech COVID-19 vaccine; or regarding potential future revenues from the contract manufacturing agreement with BioNTech for the Pfizer-BioNTech COVID-19 vaccine. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that our manufacturing of the the Pfizer-BioNTech COVID-19 vaccine will be successful. Nor can there be any guarantee that the our contract manufacturing agreement with BioNTech for the Pfizer-BioNTech COVID-19 will be commercially successful. In particular, our expectations regarding the manufacture of the Pfizer-BioNTech COVID-19 vaccine could be affected by, among other things, the uncertainties inherent in the manufacturing process of an mRNA vaccine; safety, quality, data integrity or manufacturing issues inherent in manufacturing an mRNA vaccine; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
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