BioNTech/Pfizer Raise 2021 Vaccine Production Target

01.04.2021 - Germany’s BioNTech and US drugmaker Pfizer have again corrected upward the 2021 production forecast for their Covid-19 vaccine marketed as Comirnaty. The partners now say they will manufacture an additional 500 million doses this year, lifting the output target to 2.5 billion doses. After last year’s pledge to produce 1.3 billion doses this year, in January they raised the target to 2 billion.

Presenting annual results for 2020, Mainz-based BioNTech said the more optimistic forecast is driven by the optimization of production processes and the recent initiation of production at its Marburg facility in Germany, along with regulatory approval for six dose vials and the expansion of its manufacturing and supplier network. Additional measures and discussions with potential partners to further expand the manufacturing capacity and network are ongoing, it said.

The approvals make BioNTech’s Marburg site – acquired last year from Novartis – one of the largest mRNA vaccine manufacturing sites worldwide with an annual capacity of up to 1 billion. The first batches manufactured at Marburg are expected to be delivered in the second half of April. In the year’s first half, BioNTech plans to produce up to 250 million doses. Together with Pfizer, it has signed orders of 1.4 billion doses for delivery in 2021. Under the revenue splitting agreement, this would generate €9.8 billion in sales for BioNTech.

Discussions over additional dose commitments are in progress, the German biotech said. The US has exercised its option for an additional 100 million doses, bringing its total order to 300 million. The EU has agreed to take an additional 200 million doses, for a total of 500m, with the option to order 100 million more.

BioNTech plans to formulate two alternative versions of the Covid vaccine, freeze-dried and powdered, which could eliminate some of the cold storage drawbacks the shot has faced. The company is fast-tracking development of the new formulations and said it does not currently expect additional clinical studies to be required. Trials with the freeze-dried version could start in April. The European Medicines Agency recently approved transport of the vaccine at minus 15°C, warmer than the original minus 27C.

The year 2020 was a transformational one for the German biotech with the development and approval of its shot, the first mRNA drug in history. “As of March 2021, we had delivered more than 200 million doses of our vaccine to more than 65 countries and regions together with our partners, and we are already seeing the first signs of vaccine associated reduction of Covid-19 cases and mortality in multiple countries,” CEO and co-founder Ugur Sahin said.

For the fourth quarter, the company whose name was on hardly anyone’s lips a year earlier, reported €366.9 million in net profit, compared with a net loss of €58.2 million a year earlier. Net earnings for the full year came in at €15.2 million after a €179.2 million net loss for 2019.

When the coronavirus pandemic no longer commands its full attention, BioNTech has said it wants to use some of the proceeds from vaccine sales to fund research in other fields, including cancer, it its original focus before the virus reared its head. The oncology pipeline has 13 product candidates in 14 ongoing trials. For 2021, the company has budgeted €750 to €850 million.

Author: Dede Williams, Freelance Journalist