Novartis To Make Pfizer/BioNTech COVID-19 Vaccine in Slovenia

Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--Novartis International AG (NYSE:NVS) (Basel, Switzerland) has inked a new deal to boost the manufacturing capacity of the Pfizer-BioNTech COVID-19 vaccine, COMINARTY, at its sterile fill-finish plant in Ljubljana, Slovenia.

The company, which has been offering fill and finish capacity to Pfizer-BioNTech at its facility in Stein, Switzerland, will begin to shift the manufacturing to Slovenia where it estimates it can produce about 24 million doses in 2022. The facility in Ljubljana is a state-of-the-art aseptic filling operation that already manufactures and supplies a broad range of aseptic products for Sandoz, a Novartis division.

Under the terms of the agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under sterile conditions for shipment back to BioNTech for distribution. Novartis plans to transfer the manufacturing process from Stein to Ljubljana to commence the fill and finish process in the first half of next year. Novartis started filling for BioNTech at its Stein site in Switzerland in June, after the European Union's drug regulator EMA approved the fill and finish plant. It was one of a number plants approved by the EMA as Europe attempted to ramp up production of viable COVID-19 vaccines.

In May, Industrial Info reported that the EMA had fast-tracked increased manufacturing capacity for COVID-19 vaccines at sites in Belgium and Spain as it sought to overcome notable shortages in vaccine delivery. For additional information, see May 3, 2021, article-Europe Green Lights More COVID-19 Production Capacity. In September, the EMA also granted permission for new manufacturing capacity in France, Germany and the U.S to help boost supplies by up to 400 million doses. For additional information, see August, 2021, article-EU Adds New COVID-19 Manufacturing Capacity.

In related news, Germany's CureVac and pharmaceutical major Bayer AG (Leverkusen, Germany) announced they were parting ways on their proposed COVID-19 manufacturing deal, reported by Industrial Info at the start of the year. For additional information, see January 26, 2021, article-CureVac Taps Bayer to Ramp Up COVID-19 Vaccine Rollout. A Bayer spokesman confirmed to Germany's Rheinische Post that they "have decided by mutual agreement to not continue cooperation." The news comes just days after CureVac announced it was ending its first-generation COVID-19 vaccine efforts, following a disappointing Phase 3 clinical trial result this summer that showed its CVnCoV vaccine had an efficacy of just 48%. In addition, existing contracts with WACKER for the manufacturing of the mRNA drug substance of CVnCoV and Celonic for the manufacturing and formulation of the mRNA drug substance of CVnCoV are also being terminated.

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