Moderna inks deal for overseas Covid-19 vaccine finishing work as European approval hangs in balance
Despite a lack of formal approval from the European Medicines Agency, Moderna is moving to nail down production capacity for the doses of its mRNA-based Covid-19 vaccine that will be jabbed into arms outside of the U.S.
Just before the new year, Moderna inked a deal with Recipharm, the Swedish CDMO, for formulating and fill-finish work on an undisclosed portion of Moderna’s vaccine supply outside of the US at Recipharm’s drug product manufacturing facility located in France.
Financial terms of the Recipharm-Moderna deal were not disclosed. The deal, of course, is pending official approval for the vaccine’s administration — a key point that remains up in the air.
Reuters reported Monday that the EMA hasn’t yet been able to reach a decision on approving the vaccine, despite the regulatory agency’s human medicines committee calling an unscheduled meeting two days ahead of a planned meeting on Wednesday.
It was unclear why the committee didn’t reach a decision, and while an approval could still come Wednesday, the process remains a bit murky.
“This is how it goes, of course we had hoped for more, but we knew it could be impossible to answer all questions in detail in one meeting,” CBG chairman Ton de Boer told Reuters. “I hope there will be a decision on Wednesday. But I don’t know.”
The EMA has set a Jan. 12 deadline for whether to recommend Moderna’s vaccine for usage. It recommended the Pfizer-BioNTech vaccine for usage in treating the respiratory virus on Dec. 21.