Pfizer/BioNTech To Increase Mfg for COVID-19 Vaccine

Pfizer and BioNTech plan to increase manufacturing of their COVID-19 vaccine in 2021 from 1.3 billion doses to 2 billion doses on a global basis and formed an initial manufacturing pact with Novartis.

To enable the increase in manufacturing, the companies proceeding with three plans. The modification of production processes at Pfizer’s facility in Puurs, Belgium, has been completed. The companies say that they are now back to the original schedule of vaccine dose deliveries to the European Union. Also, BioNTech’s manufacturing site in Marburg, Germany has received a manufacturing license and will be able to start production for validation by the European Medicines Agency in February (February 2021) in line with previously announced plans.

Pfizer and BioNTech report that they continue to work toward increased deliveries beginning the week of February 15, 2020 to ensure the supply of the full quantity of vaccine doses in the first quarter they contractually committed to and up to an additional 75 million doses to the European Union in the second quarter of 2021.

In addition, Pfizer and BioNTech’s European manufacturing network has expanded from three partners in December 2020, when the companies received their first authorizations, to 13, which includes BioNTech’s Marburg facility. The companies say they are further strengthening their manufacturing network for the vaccine and are in discussions with additional partners on potential new agreements.

Last week (January 29, 2021), Novartis signed an initial agreement to use its manufacturing capacity and capabilities for the production of the Pfizer’s and BioNTech’s COVID-19 vaccine. Under the terms of the contract manufacturing agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for BioNTech’s distribution.

Subject to reaching a final agreement, Novartis plans to begin production in the second quarter of 2021 at its aseptic manufacturing plant in Stein, Switzerland. Initial shipment of finished product is expected in the third quarter of 2021.

Novartis says its manufacturing team is in advanced discussions with additional companies to take on manufacturing activities such as mRNA production, therapeutic protein production as well as raw material production for COVID vaccines and therapeutics. The company says specifics will be disclosed once those discussions are concluded.

Source: BioNTech and Novartis

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