Europe Clears Extra COVID-19 Manufacturing Sites to Boost Supplies

Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--Europe has fast-tracked new manufacturing capacity for the leading approved COVID-19 vaccines in order to overcome a bottleneck in supplies in recent months.

The European Medicines Agency (EMA) has approved the Halix facility in the Netherlands to produce AstraZeneca's (Cambridge, U.K.) coronavirus vaccine, a Pfizer Incorporated (NYSE:PFE) (New York, New York)/BioNTech SE (NASDAQ:BNTX) (Germany) plant in Marburg, Germany and a Swiss manufacturing plant to boost production of the Moderna (NASDAQ:MRNA) (Massachusetts) vaccine.

The Halix site has been at the centre of a bitter dispute between the European Union (EU) and AstraZeneca in recent weeks with the EU threatening to block export shipments to the U.K., claiming the company was prioritising the U.K. over the rest of Europe. AstraZeneca has so far failed to supply Europe with its agreed number of vaccines due to production problems. The European Commission (EC) has agreed to purchase 300 million doses of the vaccine, with an option for a further 100 million doses.

"A new manufacturing site has been approved for the production of AstraZeneca's COVID-19 vaccine active substance," the EMA stated. "The Halix site is located in Leiden, the Netherlands, and will bring the total number of manufacturing sites licensed for the production of the active substance of the vaccine to four. A new site has also been approved for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. The facility, which is in the German city of Marburg, will produce both active substance and the finished product. There are currently three active substance manufacturing sites supplying the EU included in the marketing authorisation."

Last September Industrial Info reported that BioNTech had announced that it was buying a manufacturing site in Germany from Novartis to increase the production capacity for its planned COVID-19 vaccine. The plant in Marburg will enable the company to eventually churn out 750 million doses per year--or more than 60 million doses per month--of the Comirnaty vaccine. For additional information, see September 28, 2020, article - BioNTech Buys German Plant to Boost COVID-19 Vaccine Production. The EC has agreed to buy up to 600 million doses of this vaccine.

In addition to the new facility, the EMA approved the transportation and storage of vials of Comirnaty at temperatures between -25 to -15˚C (i.e. the temperature of standard pharmaceutical freezers) for a one-off period of two weeks. "This is an alternative to the long-term storage of the vials at a temperature between -90 to -60˚C in special freezers," the EMA explained. "It is expected to facilitate the rapid roll-out and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold storage conditions throughout the supply chain."

The EMA also greenlit a new manufacturing site and scaled-up processes for Moderna's COVID-19 vaccine at the Lonza facility, located in Visp, Switzerland. The plant will handle the production of active substance and finished product intermediates for the vaccine. To date, the EC has signed two deals with Moderna, the first last year for 160 million doses, followed by another deal in February for 300 million doses--150 million in 2021 and an option to purchase an additional 150 million in 2022).

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