Novartis officials said the company has established an agreement leveraging its manufacturing capacity and capabilities to address the COVID-19 pandemic by expanding Pfizer-BioNTech vaccine support.
The agreement targets the fill and finish of more than 50 million doses in 2021 at the Novartis Stein site in Switzerland.
The scope of work calls for Novartis to take bulk mRNA active ingredient from BioNTech and transfer it to vials under sterile conditions for shipment to BioNTech for distribution.
Upon arriving at a final agreement, officials said Novartis seeks to transfer the manufacturing process from the Stein to Ljubljana site to begin the fill and finish during the first half of 2022.
Novartis started filling for BioNTech at its Stein site in Switzerland in June. The European Union’s drug regulator EMA approved the filling-and-finishing plant. The Pfizer-BioNTech COVID-19 vaccine is based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer.
BioNTech serves as the Marketing Authorization Holder domestically, the European Union, the United Kingdom, Canada, and the holder of Emergency Use Authorizations or equivalents in the United States and other countries.
The new agreement stems from the initial contract signed earlier this year, according to Novartis. The firm noted it began 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.