Vaccines: Europe’s access boosted as EMA approves three new production sites

Vaccines: Europe’s access boosted as EMA approves three new production sites
Halix in Leiden (NL) will produce the active compound for the AstraZeneca vaccine © Belga

The European Medicines Agency has given its approval to three new production sites for vaccines in Europe, a move designed to increase manufacturing capacity and supply of vaccines in the EU.

The Halix site in Leiden in the Netherlands will produce the active ingredient for the AstraZeneca vaccine, bringing the number of sites now in production to four.

Another site at Marburg in Germany will produce the first vaccine to receive EMA approval, made by Pfizer/BioNTech. That site will produce both the active substance and the finished product. Pfizer currently has a production plant in Puurs in Antwerp province.

At the same time, the EMA’s human medications committee has given a positive response to the transport and storage of the Pfizer vaccine at temperatures between -25°C and -15°C.

That is the standard temperature range of pharmacists’ freezers, and although transport and storage in that range is only good for two weeks maximum, it allows a great deal more flexibility than the existing required temperature range of -90°C to -60°C.

Lastly, the third new approved site concerns the Moderna vaccine, and is in Visp in Switzerland.

EMA is in continuous dialogue with the marketing authorisation holders of COVID-19 vaccines as they seek to expand their production capacity for the supply of vaccines in the EU,” the agency said in a statement on its website.

The Agency provides guidance and advice on the evidence required to support and expedite applications to add new sites for the manufacture of high-quality COVID-19 vaccines. As for any medicine in the EU, COVID-19 vaccines can only be manufactured in approved sites that are included in the marketing authorisation following regulatory assessment.”

The effect of the approval of three new production sites is difficult to predict, according to Dirk De wolf, director of the Flemish agency for health care, speaking to news agency Belga.

We have not yet received any new delivery messages. Building such a production environment is a very precise job, so it will not be completed in a few weeks, I suspect,” he said.

Alan Hope
The Brussels Times

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