An interview with Dr Steffen Lang, Global Head of Novartis Technical Operations and member of the Executive Committee of Novartis

Novartis isn’t normally involved in vaccine development, so what drove the decision to get involved in manufacturing COVID-19 vaccines?

Since the beginning of the pandemic, we have been guided by two key principles: to ensure the safety of our associates, and to ensure that patients have continued access to the medicines they need. This has required us to put in place significant measures at our sites that protect the health and wellbeing of our people, while continuing to keep all our facilities open and operational. I’m proud that we have continued to supply medicines at near normal levels over the past 12 months, despite the unprecedented challenges we’ve faced, and we are committed to maintaining that reliable supply.

As a leading healthcare company, Novartis also has a responsibility to play an active role in the global fight against COVID-19. So, we have also gone beyond our existing commitments to contribute in a number of ways – e.g. by repurposing a packing line to produce vials for test kits in Switzerland, and producing large quantities of disinfectant at a number of our locations to supply the communities in which we work. The Novartis generics and biosimilars division, Sandoz, also became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19, and we have made available 15 drugs that treat key symptoms of COVID-19 to low- and lower-middle income countries at zero profit.

Now, with the approval of several COVID-19 vaccines, there is growing hope that the world might find a way to end the COVID-19 pandemic – and this represents an opportunity for Novartis Technical Operations (NTO) to leverage our technical expertise and our state-of-the-art facilities to contribute to the effort.

There are huge challenges to the vaccine roll out, central to which is a bottleneck in manufacturing that is making it hard for companies to meet demand. The response from industry and Governments has been an unprecedented level of collaboration, with companies, healthcare authorities and academic institutions joining forces to use their collective innovation power and global footprints to support the manufacturing and supply of vaccines. Here at Novartis, we no longer have a vaccines business, but we do have one of the largest and most diverse manufacturing operations in the industry. We are proud to have entered into agreements to help manufacture two different mRNA-based COVID-19 vaccines – the Pfizer-BioNTech vaccine and the CureVac vaccine – in our state-of-the-art aseptic facilities in Stein, Switzerland, and Kundl, Austria, to help improve access for people around the world.

You have announced partnerships with both BioNTech and CureVac. What will the role of Novartis be?

Overall, we support the manufacturing of COVID-19 vaccines at various stages of the process and in multiple Novartis production sites. As per our initial agreement with Pfizer-BioNTech, we plan to take bulk mRNA active ingredient from them and fill this into vials under aseptic conditions for shipment back to BioNTech, so they can distribute the finished vaccine to healthcare system customers around the world.

For CureVac, with whom we signed an initial agreement in March, the plan is to produce the mRNA and bulk drug product, which will then be delivered to CureVac for further processing and filling. Production for CureVac will take place in a new, high-tech production facility in Austria. The facility was already under construction prior to the agreement being signed, and it is now being adapted to the needs of mRNA vaccine production – a highly complex process.

What is the strategic rationale for these agreements?

Vaccinating the world is a colossal task. Pre-COVID-19, annual global vaccine production was estimated at five billion doses for all vaccines. In 2021, production of COVID-19 vaccines alone is estimated to reach almost 10 billion. So vaccine manufacturers are scaling up from zero to billions of doses in record time.

Vaccine manufacturing is highly complex. COVID-19 vaccines require precision and expertise to manufacture, and involve cutting-edge science and technologies. Not only that, but the highest regulatory standards for safety and quality must be met dose after dose.

At Novartis, our mission is to help our patients live longer, healthier lives, and here in NTO, we possess expertise and resources that are vital in producing the vaccines that will bring the pandemic under control. Over the last 12 months or so, we have seen unprecedented collaboration in the biomedical industry, leading to rapid innovation in vaccine and therapeutics development. In keeping with our mission, we see it as our responsibility to take a leading role in this collaboration, and to use our footprint and experience to support and accelerate vaccines production. We will continue working with our partners to do so, and, looking ahead, will continue to explore new opportunities to contribute to the global effort against COVID-19.

From a European perspective, there has been a great deal of debate around manufacturing and supply of vaccines, including the introduction of an export authorisation mechanism. In your view, how can Europe help to accelerate the production of vaccines for citizens in Europe and around the world?

Governments and industry must continue to work together to rapidly develop, test, and distribute COVID-19 vaccines. That requires addressing and ultimately eliminating regulatory approval delays, unnecessary supply chain barriers such as export bans, excessive stockpiling and allocation requirements. Supporting manufacturing partnerships around the world is incredibly important in accelerating access. Vaccine manufacturing is a global process and so its supply chains are global – it is essential to keep open borders and free flow of goods. Any potential export restrictions would risk delays in COVID-19 vaccine manufacturing and distribution, delaying the rollout of the vaccines across and beyond Europe, and also risking potential retaliatory measures from other regions.