Novartis, BioNTech ink pact to support fill, finish of mRNA Pfizer-BioNTech COVID vaccine

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 company said in a release.

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.