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EMA recommends new manufacturing sites for COVID-19 vaccines

EMA also recommends new storage temperature for Pfizer/BioNTech vaccine

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended new manufacturing capacity and supply for several COVID-19 vaccines.

The CHMP has recommended approval for a new manufacturing site for the production of the active substance used in the AstraZeneca (AZ) COVID-19 vaccine.

The site, located in Leiden, the Netherlands and operated by contract development and manufacturing organisation (CDMO) Halix, will bring the total number of manufacturing plants licensed for the production of the AZ vaccine’s active substance to four.

The Dutch manufacturing site had been caught in the middle of the EU-UK vaccine row, with an EU official telling Reuters last week that “the Brits are insisting that the Halix plant in the Netherlands must deliver the drug substance produced there to them. That doesn’t work. What is produced in Halix has to go to the EU”.

The CHMP has also recommended a new manufacturing site for Pfizer/BioNTech’s vaccine, located in the German city of Marburg.

This site will produce both the active substance for the vaccine as well as the finished product, according to the EMA.

In addition to the new manufacturing site approval, the CHMP has also adopted a positive opinion for a new transportation and storage temperature for vials of the Pfizer/BioNTech vaccine.

The vaccine can now be transported and stored at temperatures between -25˚C to -15˚C – the standard temperature of pharmaceutical freezers – for a period of two weeks.

Originally, the Pfizer/BioNTech vaccine was required to be stored at a temperature between  -90˚C to -60˚C in special freezers.

The CHMP has also recommended approving the addition of a new manufacturing site for the production of the active substance, as well as finished product intermediates, for Moderna’s COVID-19 vaccine.

The new manufacturing lines, located at a facility in Visp, Switzerland are hoped to bolster scale-up of production capacity for the Moderna vaccine and increase supplies for the EU market.

The new manufacturing and storage recommendations come following a summit meeting last week where European Union leaders discussed possible COVID-19 vaccine export measures in a bid to bolster the bloc’s vaccination roll-out.

Article by
Lucy Parsons

29th March 2021

From: Regulatory



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