The European Medicines Agency (EMA) has approved a Delpharm plant in France and a Catalent facility in the US to support supply of Pfizer and Moderna’s COVID-19 vaccines, respectively.
The approvals from the EMA’s human medicines committee (CHMP) this week aim to increase manufacturing capacity and supply of the two COVID-19 vaccines in the EU.
The first saw the Agency approve a fill-finish site in Saint Remy sur Avre, France operated by contract development and manufacturing organization (CDMO) Delpharm. The facility will support production of Comirnaty, developed by BioNTech and Pfizer, which became the first US FDA fully approved COVID-19 vaccine earlier this week.
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The drug manufacturing plant specializes in sterile liquid and freeze-drying dosage forms and according to the EMA will help supply around 51 million additional doses in 2021.
The approval comes in unison with a new manufacturing line at BioNTech’s manufacturing site in Marburg, Germany. The site, acquired by BioNTech from Novartis last year, is set to increase active substance manufacturing capacity by 410 million doses in 2021.
Meanwhile, the EMA approval of Catalent’s Bloomington, Indiana facility will support Spikevax, the COVID-19 vaccine developed by Moderna (full licensure of which was submitted today to the US FDA).
Moderna first contracted Catalent for its then prospective COVID-19 vaccine in June 2020, but with the rapid rollout the CDMO recently dedicated a high-speed vial filling line to Moderna at the Bloomington plant.
Additionally, the CHMP has approved several alternative sites responsible for batch control/testing and packaging of the finished product manufactured by Catalent.
The approval comes weeks after the EMA approved a scale-up of the active substance manufacturing at Moderna’s own site in Norwood, Massachusetts and at CDMO Lonza’s site in Portsmouth, New Hampshire.
In total, the EMA predicts these approvals will bolster European supply of Spikevax by 40 million doses in the third quarter of this year.