The deal is the first of potentially ‘multiple’ such agreements to support manufacture of COVID-19 vaccines.

The agreement sees Novartis provide aseptic manufacturing services from its Stein, Switzerland, facility for the production of Pfizer and BioNTech’s COVID-19 vaccine.

Novartis will provide the services under a contract manufacturing agreement that sees the company take bulk mRNA active ingredient from BioNTech and fill this into vials, before shipping the vials back to BioNTech for distribution.

Image: iStock/IRINA KROLEVETC

The Swiss company announced that it would be ready to commence production in the second quarter of 2021, with the first shipment expected in the following quarter.

Beyond this agreement, Novartis stated that its manufacturing team is in additional discussions to provide similar services to other developers of vaccines and therapeutics, including providing mRNA, therapeutic protein, and raw material production.

A spokesperson for the company explained to BioProcess Insider that such actions are part of the ‘unprecedented level of collaboration’ occurring across the industry.

“Across the industry, we are sharing our scientific findings, our research and our manufacturing capacity while committing to equitable distribution of diagnostics, therapeutics and vaccines,” the spokesperson added.

Novartis does not currently have a vaccine in development, instead CEO Vas Narasimhan confirmed last year that the company will focus on therapeutics against the virus.

The agreement with Pfizer and BioNTech follows on from a similar arrangement the company had made with Massachusetts Eye and Ear and Massachusetts General Hospital to provide manufacturing services from capacity allotted to its AveXis gene therapy subsidiary.

Industry-wide efforts

Novartis is not the first company to have offered its services to Pfizer and BioNTech, after Sanofi announced late last month that it would also provide fill and finish for up to 125 million doses of the mRNA vaccine.

A spokesperson for the European Federation for Pharmaceutical Industries and Associations (EFPIA) stated, “Vaccine manufacturers have been working around the clock to increase their manufacturing capacity and finding new partnerships in order to produce large volumes of COVID-19 vaccines without ever compromising on the quality or safety of the vaccines.”

Ensuring sufficient supply of vaccines has been one of the major challenges for the manufacturers that have received approvals, which the spokesperson referred to as an ‘unprecedented challenge’.

Supply of available vaccines has led to some contention over the number of vaccines being delivered to particular regions; the European Commission took the step of publishing its contract with AstraZeneca, after productions problems led AZ to reduce the number of vaccines that would be made available in the EU in the first quarter of the year.

Currently over seven million doses have been delivered to the European Union (EU) since the first vaccine was approved, the EFPIA spokesperson outlined.

The spokesperson concluded, “Fluctuations in the supply of doses, however frustrating, can be a feature of manufacturing complex biological products.”