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EMA approves several vaccine manufacturing facilities, including AstraZeneca's Halix site

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The European Medicine’s Agency (EMA) human medicines committee (CHMP) has adopted several recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.

New manufacturing site for AstraZeneca’s COVID-19 vaccine

A new manufacturing site has been approved for the production of AstraZeneca’s COVID-19 vaccine active substance. 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.

AstraZeneca finally submitted its application for EMA approval for the site two days ago, it is unclear why it has taken so long to apply for approval.

When the advanced purchase agreement was agreed in August last year AZ CEO Pascal Soriot said: “With production in our European supply chain soon to be started, we hope to make the vaccine available widely and rapidly, with the first doses to be delivered by the end of 2020. I would like to thank the entire European Commission, and especially the Commissioner for Health and Food Safety, Stella Kyriakides, for their swift response in ensuring Europeans may soon be protected with a vaccine against this deadly virus, enabling our global society and economy to rebuild.”

More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine

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.

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In addition to the new manufacturing facility for this vaccine, EMA is also allowing the company to transport and store the vials of the vaccine 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 expected to facilitate the rapid roll-out and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold  (-90 to -60˚C) storage in special freezers throughout the supply chain. 

Scale-up processes for Moderna’s COVID-19 vaccine

In addition to the approval for a new manufacturing site for the production of active substance and finished product intermediates last week, Moderna will add new manufacturing lines at the Lonza facility, located in Visp, Switzerland, together with other changes to the manufacturing processes that are intended to scale-up production capacity and increase supply of the vaccine for the EU market.

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