europeanpharmaceuticalreviewDecember 22, 2020
Tag: EC , Moderna , COVID-19 vaccine
Moderna has announced that the European Commission (EC) has exercised its option to purchase an additional 80 million doses of mRNA-1273, the company’s COVID-19 vaccine candidate, bringing its
confirmed order commitment to 160 million doses.
The first deliveries of mRNA-1273 to European countries from Modena’s dedicated European supply chain are expected to commence early in 2021, following regulatory approval by the European Medicines Agency (EMA).
These deliveries are subject to receipt of the positive opinion from the EMA’s committee for human medicines (CHMP) and the EC’s decision regarding the Conditional Marketing Authorisation (CMA)
for the vaccine. The CHMP meeting is planned for 6 January 2021.
mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilised form of the Spike (S) protein, which was co-developed by Moderna and investigators from the US National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center.
“We appreciate the confidence in Moderna and mRNA-1273, our COVID-19 vaccine candidate, demonstrated by today’s increased supply agreement with the EC,” said Stéphane Bancel, Chief Executive Officer of Moderna. “As we shift our focus now to prepare for the delivery of our vaccine candidate, pending a positive opinion from the EMA and other regulators, we remain committed to working with governments and partners globally to address this pandemic.”
Moderna has confirmed the following supply agreements of committed orders totalling more than 470 million doses:
United States: 200 million doses with option for an additional 300 million doses
EU: 160 million doses
Japan: 50 million doses
Canada: 40 million doses with option for an additional 16 million doses
Switzerland: 7.5 million doses
UK: seven million doses
Israel: six million doses.
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