- 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 blazoned moment that it has inked an original agreement to work its manufacturing capacity and capabilities to address the COVID-19 epidemic by expanding its support of the filler and finish of the Pfizer-BioNTech COVID-19 vaccine. Novartis will use its sterile manufacturing installations at its Novartis Technical Operations point in Ljubljana, Slovenia, to fill at least 24 million boluses in 2022.
Under the terms of the new original agreement, Novartis plans to take bulk mRNA active component from BioNTech and fill this into vials under sterile conditions for payload back to BioNTech for its distribution. Subject to reaching a final agreement, Novartis plans to transfer the manufacturing process from Stein to Ljubljana point to commence the filler and finish in the first half of 2022. The installation in Ljubljana is a state-of-the- art aseptic filling operation which manufactures and supplies a broad range of sterile products for Sandoz, a Novartis division.
This new agreement follows a first contract inked before this time. Novartis started filling for BioNTech at its Stein point in Switzerland in June after the European Union’s medicine controller EMA approved the stuffing-and- finishing factory.
Novartis continues to offer its world- class capabilities to other companies to take over manufacturing conditioning including a variety of technologies similar as mRNA product and others. The specifics will be bared when we conclude specific agreements.
The Pfizer-BioNTech COVID-19 vaccine, which is grounded on BioNTech’s personal 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 coequals in the United States ( concertedly with Pfizer) and other countries. Cessions to pursue nonsupervisory blessings in those countries where Emergency Use Authorizations or original were originally granted are planned.
Pfizer-BioNTech COVID-19 vaccine; or regarding implicit unborn earnings from the contract manufacturing agreement with BioNTech for the Pfizer-BioNTech COVID-19 vaccine. You shouldn’t place overdue reliance on these statements. Similar forward- looking statements are grounded on our current beliefs and prospects regarding unborn events, and are subject to significant known and unknown pitfalls and misgivings. Should one or further of these pitfalls or misgivings materialize, or should underpinning hypotheticals prove incorrect, factual 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 prospects regarding the manufacture of the Pfizer-BioNTech COVID-19 vaccine could be affected by, among other effects, the misgivings essential in the manufacturing process of an mRNA vaccine; safety, quality, data integrity or manufacturing issues essential in manufacturing an mRNA vaccine; nonsupervisory conduct or detainments or government regulation generally; the particular defining preferences of croakers and cases; general political, profitable and business conditions, including the goods of and sweats to alleviate epidemic conditions similar as COVID-19; eventuality or factual data security and data sequestration breaches, or dislocations of our information technology systems, and other pitfalls and factors appertained to in Novartis AG’s current Form 20-F on train with the US Securities and Exchange Commission. Novartis is furnishing the information in this media update as of this date and doesn’t shoulder any obligation to modernize any forward- looking statements contained in this media update as a result of new information, unborn events or else.
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