EU approval boosts COVID vaccine manufacturing capacity

The European Medicines Agency (EMA) has approved additional manufacturing capacity for the Pfizer/BioNTech COVID-19 vaccine in France – increasing production by 51 million doses by the end of 2021. The site, located in Saint Rémy sur Avre, France, is operated by Delpharm and will manufacture finished product.

The regulator also approved a new manufacturing line at BioNTech’s site in Marburg, Germany, which increases the active substance manufacturing capacity by approximately 410 million doses this year.

Production of the Spikevax vaccine developed by Moderna will also increase after a manufacturing site in Bloomington, Indiana (US) was given the green light by the EU drug watchdog. This allows the company to export vaccines made at this site to European countries and others that follow EMA recommendations.

In addition to the new manufacturing facility for this vaccine, the Amsterdam-based EMA has also approved several alternative sites responsible for batch control/testing and packaging of the finished product manufactured by Catalent.

Production of COVID-19 vaccines is seen as a race against time, with the more infectious Delta variant spreading around the world. In Europe, more than 75% of adults have received two doses, with more than 90% having had at least one dose. Several EU states are now preparing to offer booster vaccines – a third dose – to older and vulnerable populations, while Pfizer and Modern continue to develop Delta-specific versions of their vaccine.

However, with low-resource countries struggling to roll out immunisation programmes at scale – due in part to limited supply of vaccines – the World Health Organisation has called on high-income countries to postpone booster programmes until more of the world’s population has been offered their first and second doses.