BioNTech has strengthened its vaccine manufacturing capacity following a deal with Novartis for a production site in Germany, ahead of the planned filing of its coronavirus shot in October.
According to BioNTech, the deal will expand its COVID-19 vaccine production capacity by up to 750 million doses per year once the site, based in the German city of Marburg, is fully operational.
In the first half of 2021, BioNTech added that it hopes to produce up to 250 million doses of its Pfizer-partnered BNT162b2 shot at the Novartis site.
The Marburg site is fully equipped for the production of recombinant proteins as well as cell and gene therapies, with Novartis having significantly invested in the site over the past five years. BioNTech and Novartis did not disclose the financial terms of the deal, although BioNTech said that the transaction is expected to close in the fourth quarter of 2020.
“We are working closely with Novartis to prepare for a smooth transition, and we look forward to welcoming the new members of our team and tapping into their impressive skills and expertise,” said Sierk Poetting, chief financial officer and chief operating officer at BioNTech.
“From a strategic standpoint, the new site will bolster our vertically integrated business model with in-house manufacturing capabilities for mRNA manufacturing as well as vaccine formulation,” he added.
In July, Pfizer and BioNTech revealed the early positive data from their mRNA-based COVID-19 vaccine programme, with two of the candidates – BNT162b1 and BNT162b – demonstrating promising dose-dependent immunogenicity.
However, the partners chose to advance BNT162b2 into the later clinical testing stages thanks to its favourable safety profile – detailed data from the same early study showed that there were less systemic events following administration with BNT162b2 compared to those experienced with BNT162b1.
BioNTech also announced this week that it had been awarded a €375m grant from an initiative by the German Federal Ministry of Education and Research (BMBF), to support the accelerated development of SARS-CoV-2 targeting vaccines.
The initiative is focused on expanding the vaccine development and manufacturing capabilities in Germany, as well as the expansion of the number of participants in late-stage clinical trials. In a statement, the German biotech company said that it will use the funding to cover its expenses related to its Pfizer-partnered BNT162 programme.
BioNTech and Pfizer have previously said that they are on track to submit BNT162b for regulatory review by October, if all goes to plan in the ongoing efficacy studies. Following approval, the companies added that they will supply up to 100 million doses globally by the end of the year as well as an additional 1.3 billion doses by the end of 2021.