Pfizer/BioNTech Provide Production Updates for COVID-19 VaccineBy
BioNTech, a Mainz, Germany-based immunotherapy company, is increasing production at its site in Marburg, Germany as part of a plan by Pfizer/BioNTech to increase global production of their COVID-19 vaccine from 1.3 billion doses to 2 billion doses.
Pfizer and BioNTech have increased manufacturing capacity to up to 2 billion doses of their COVID-19 vaccine for 2021, assuming continuous process improvements, expansion at current facilities, adding new suppliers and contract manufacturers, and an updated six-dose labeling (after dilution, vials of Pfizer/BioNTech’s COVID-19 vaccine contains six doses of 0.3-mL of vaccine).
BioNTech plans to be able to produce up to 250 million doses of the COVID-19 vaccine in the first half of 2021. The first vaccines manufactured at the Marburg site are scheduled for distribution in early April (April 2021).
BioNTech plans to start the manufacturing of the drug substance based on the new manufacturing license granted from the Darmstadt Regional Administrative Council for the amended facility in Marburg.
BioNTech is the marketing authorization holder in the European Union, and the holder of emergency use authorizations or equivalent in the US, UK, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.
BioNTech is also expanding its strategic partnership with Merck KGaA to accelerate the supply of lipids and increase the amount of lipid delivery toward the end of 2021. The lipids will be used for the production of the Pfizer-BioNTech COVID-19 vaccine.
In the past weeks (as reported on February 5, 2021), Merck KGaA has been working to expand its lipid production capacity with further development of production technologies and the implementation of new process steps. The companies say they are currently defining exact requirements and are aiming for a timely execution of joint efforts.