On a quest to turn out 2 billion doses of their COVID-19 vaccine Comirnaty this year, Pfizer and BioNTech just scored a major boost thanks to the European approval of a linchpin manufacturing plant in Germany.
BioNTech won a thumbs up from the European Medicines Agency (EMA) to start making and supplying partners with vaccine drug product from the Marburg, Germany facility it picked up from Novartis last fall. The regulator this week cleared BioNTech to manufacture messenger RNA—the vaccine's active ingredient—there, making it one of the largest mRNA production sites globally, BioNTech said in a release.
Once fully operational, the site is expected to hit annual capacity of up to 1 billion vaccine doses per year, the company said. That's 250 million doses more than BioNTech said the site would be able to turn out last month. The company hopes to produce 250 million doses there in the first half of the year, and the first Marburg-made shots are expected to roll out in the second half of April.
The EMA approval clears the way for BioNTech to deliver its first drug product batches from Marburg to partner sites for fill and finish and, ultimately, distribution to the European Union and other countries worldwide.
BioNTech has a workforce of 400 at the plant and the team works around the clock to maximize output. The company started mRNA manufacturing at Marburg in early February after it bought the former Novartis site in September, right around the time its COVID-19 vaccine was making waves in clinical testing.
The company has said the plant is a "key factor" in its push to deliver 2 billion doses this year with its partner Pfizer.
The plant approval should help BioNTech and Pfizer meet their supply commitments in Europe, which recently purchased additional mRNA vaccine doses from the partners and Moderna after ongoing supply issues linked to AstraZeneca's shot. Pfizer and BioNTech in mid-February pledged to deliver 200 million more doses, lifting the bloc's total order to 500 million Comirnaty vaccines.
Meanwhile, Thermo Fisher Scientific this week said it would chip in on production of Pfizer and BioNTech's shot, too. The company will perform fill-finish work at its site in Monza, Italy, during 2021, a Thermo Fisher spokesperson told Fierce Pharma via email.
Separately, the EMA this week approved storage of the Pfizer-BioNTech vaccine between minus 25 degrees Celsius (minus 13 degrees Fahrenheit) and minus 15 degrees C (5 degrees F) for up to two weeks, thanks to data showing the vaccine is stable at those temperatures in standard pharmaceutical freezers. Pfizer is also testing powder formulation that could be kept in the fridge.