Pharmaceutical Business review

EMA’s CHMP approves Moderna’s new Covid-19 vaccine manufacturing site in France

Moderna is boosting Covid-19 vaccine capacity with new manufacturing facility in France. Credit: Gerd Altmann from Pixabay.

Biotechnology company Moderna has secured approval from the European Medicines Agency’s (EMA) committee for human medicines (CHMP) for a new Covid-19 vaccine manufacturing site in Monts, France.

Addition of many other alternative sites that will be responsible for batch control/testing were are also approved by the regulator.

Earlier this year, CHMP approved two new manufacturing sites to produce finished product intermediates and active substance in the US.

The facilities include ModernaTX located in Norwood, Massachusetts and Lonza Biologics in Portsmouth, New Hampshire.

These two manufacturing facilities together are expected to support the production of an additional one to two million ready-to-use vaccine for the European Union market monthly.

In a separate development, Tabuk Pharmaceuticals has entered into an agreement with Moderna to commercialise its Covid-19 vaccine as well as future variant-specific booster candidates in Saudi Arabia.

Tabuk will hold the marketing authorisation of the Moderna’s Covid-19 vaccine in Saudi Arabia as per the terms of the deal.

Moderna CEO Stéphane Bancel said: “It is thanks to partnerships such as these that we are able to expand access to our vaccine globally, and we hope it will support the availability of our COVID-19 vaccine for the benefit of the people of Saudi Arabia.

“We are pleased to have secured a new agreement to supply our COVID-19 vaccine and our updated variant booster vaccine candidate, if authorized, to Saudi Arabia for 2021 and 2022.”

Under the terms of the agreement, Tabuk will also have option to discuss other opportunities with Moderna to distribute the company’s other mRNA products if authorised in the future.