Eyeing a boost to its COVID-19 vaccine supply, the European Union’s drug regulator has approved two manufacturing sites and a new BioNTech line it hopes will churn out millions of additional mRNA doses by the end of the year.
A key European Medicines Agency (EMA) committee approved two new manufacturing sites—owned by Delpharm and Catalent—and a new line at a BioNTech facility to help produce the Pfizer and Moderna shots.
For Pfizer’s shot, the EMA’s Committee for Medicinal Products for Human Use (CHMP) awarded a Delpharm-owned site in Saint Rémy sur Avre, France, the go ahead to manufacture finished product.
The French CDMO first drummed up a deal with BioNTech late last year to produce “millions” of doses starting this April with plans to hire up to 60 more people. Delpharm’s site will boost the EU’s expected supply of that shot, known as Comirnaty, by roughly 51 million additional doses by the end of 2021, the EMA says.
Over at BioNTech’s facility in Marburg, Germany, the committee also approved a new manufacturing line that will expand the active substance capacity for Pfizer’s jab by a whopping 410 million doses this year, officials say.
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Across the pond, Catalent has scored a blessing to manufacture Europe-bound Moderna doses at its plant in Bloomington, Indiana.
Catalent is no stranger to the pandemic fight. The CDMO juggernaut funneled $50 million into a new line at its Indiana hub to help bolster its manufacturing capacity for both Moderna’s jab and Johnson & Johnson’s one-shot vaccine. The company also provides fill-finish duties for AstraZeneca’s vaccine at a former Bristol Myers Squibb plant in Anagni, Italy.
Catalent’s nod comes less than a month after European regulators awarded Moderna’s Norwood, Massachusetts, facility and Lonza’s Portsmouth, New Hampshire, site its blessing to scale up active drug manufacturing in late July. All together, the EU expects an additional 40 million Spikevax doses in the third quarter from those factories, the EMA said.
Since the committee’s decision to approve the additional facilities doesn’t require a final nod from the European Commission, the sites can begin production immediately, according to a statement.
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The news comes as a handful of European countries, faced with numerous delivery delays and safety concerns from AstraZeneca and Johnson & Johnson’s jabs, move toward the mRNA rivals from Moderna and Pfizer instead.
In May, Pfizer agreed to supply the EU up to a whopping 1.8 billion doses through 2023 on top of the 600 million it had already committed to delivering by the end of this year. Pfizer and German partner BioNTech expect to deliver 2.1 billion doses globally by the end of the year and manufacture 3 billion.
That same month, Moderna inked a deal with the EU worth 150 million doses for 2022, including the option for boosters. That brought its total order from the bloc up to 460 million doses.
Moderna has made a number of manufacturing upgrades in recent months to rapidly scale its mRNA production capabilities following an onslaught of supply orders. The drugmaker expects to make 2 billion to 3 billion doses in 2022, with its entire supply this year of up to 1 billion doses already snapped up.
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