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Novartis Offers EU Help on Vaccine Supply Front

29.01.2021 - With news of an EU Covid-19 vaccine shortage dominating international headlines, another European player is stepping up to try to bridge the gap. On the heels of French drugmaker Sanofi, Swiss pharma giant Novartis said this week it is exploring whether it can deploy its own manufacturing network to boost supply.

Novartis, which said it sees controlling the pandemic as "one of the most pressing concerns for leaders, businesses and individuals all across the world,” said it is "currently in discussions with several companies with a view to supporting the manufacturing of vaccines and components for tests for Covid-19.”

In the current era, the Swiss player has not been closely involved in Covid-19 vaccines, or any vaccines, having sold that business to GSK several years ago. However, its gene therapy arm AveXis is working with a US team looking to produce an early-stage Covid gene therapy as part of a project at Massachusetts General Hospital in Boston.

CEO Vas Narasimhan told the Bloomberg news agency that Novartis expects to reach an agreement on a collaboration in the coming days or weeks. "We have production capacity across our network that we’re willing to make available, for everything from monoclonal antibodies to vaccine production,” he said.

Bloomberg noted that Narasimhan, a physician who once led the company’s vaccines unit, has personal experience in a pandemic, having overseen the drugmaker’s response to the H1N1 swine flu pandemic in 2009.

The Novartis and Sanofi pinch-hitting – which many commentators are praising as a much needed display of pharma industry solidarity in unusual times – could not only fill vaccine production gaps if successful. It could also blunt the Schadenfreude being displayed by other countries or economic blocs that see the EU strategy of trying to secure supply for 27 countries at once as having failed.

In the past two weeks, Europe has been dealt double blows. First Pfizer said it would cut supply as it retools its plant at Puurs, Belgium, in preparation for a capacity boost. Then AstraZeneca – whose vaccine is poised to be approved by the European Medicines Agency (EMA) this week – informed the EU Commission it would reduce deliveries by about 60% during the first quarter, due to production problems at an CDMO partner on the continent.

A day before Novartis announced its plans to enter the fray, Sanofi committed to producing more than 1.5 million doses of the Pfizer/BioNTech vaccine for the EU stockpile. The drugmaker said it had idle capacity at its Höchst chemical park site in Frankfurt, Germany, as its own plans to develop a Covid candidate in cooperation with GlaxoSmithKline faced delays.

Sanofi said the Frankfurt location is ideal because of its proximity to BioNtech’s vaccine production facilities at nearby Mainz. By August, it hopes to deliver the first batches of Comirnaty from a former insulin facility, for which it already has received the go-ahead to rededicate to vaccine production. Rather than producing the active ingredient, however, it will carry out fill & finish, a role that normally would fall to a CDMO.

The plant has the necessary prerequisites to produce at the minus 70°C temperature the Pfizer-BioNTech product requires, Sanofi said. BioNTech is already working together with CDMOs Rentschler Biopharm, Polymun and Dermapharm as well as Siegfried, which is also handling fill & finish.

In February, BioNTech will also begin producing the mRNA-based vaccine at Marburg, Germany, in a former Behringwerke facility acquired from Novartis last year. Darmstadt, Germany-based Merck KGaA, already supplying lipids to the Pfizer partner – which wholly owns the vaccine technology – may also provide additional support. The company said its life sciences arm is already feeding other segments of the Covid control effort.

Author: Dede Williams, Freelance Journalist