BioNTech, under pressure with its COVID-19 vaccine partner Pfizer to manufacture as many doses as possible this year, has started production at a former Novartis site it acquired in Germany.
The drugmaker has started making messenger RNA at the site, kicking off the manufacturing process for its Pfizer-partnered COVID-19 vaccine. BioNTech expects to produce up to 250 million doses of its vaccine there in the first half of 2021, and up to 750 million doses annually when the site is fully online.
The first vaccines produced there will be ready in early April, BioNTech said.
After BioNTech completes mRNA production and other manufacturing steps at Marburg, the company will move the product to a partner site for sterile fill and finishing. Two independent labs will analyze the final product.
BioNTech bought the former Novartis site in September as its COVID-19 vaccine was showing promise in clinical testing—and as the company looked for ways to boost production with partner Pfizer. The companies now say they are on track to produce up to 2 billion doses globally in 2021.
The Marburg site is a “key factor” in the partners’ push to 2 billion doses, BioNTech said, and will be one of the largest mRNA manufacturing sites in Europe.
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After buying the Marburg site last year, BioNTech made modifications and has scored a manufacturing license from the Darmstadt Regional Administrative Council. Still, the European Medicines Agency needs to sign off on the site’s production processes. The agency will conduct its review this month and next.
Just about a year after initiating development on their COVID-19 vaccine, Pfizer and BioNTech are underway with dose deliveries in many countries worldwide. The mRNA programs from the partners—plus Moderna—proved to be quicker to advance during the pandemic, and Sanofi CEO Paul Hudson recently said mRNA will likely be the “go-to” vaccine technology for single-antigen pandemics moving forward.
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The companies stand to see significant financial windfall from their quick success in the COVID-19 vaccine race. Pfizer has projected $15 billion in COVID-19 vaccine revenues in 2021, and Moderna CEO has said his company could join the ranks of the leading vaccine companies by revenue this year.