As per terms of the proposed deal, the EC can increase their purchase of Covid-19 vaccine from 80 million doses to a total of up to 160 million doses.
Moderna stated that the agreement will be finalised following a brief review period by the European Union member states.
The current approval follows the conclusion of advanced exploratory talks with the EC, which started at the end of August.
Moderna is planning to start the supply of vaccine before the first quarter of 2021 based on the approval for use by the European Medicines Agency (EMA) human medicines committee (CHMP), which began a rolling review of the Covid-19 vaccine candidate this month.
Moderna is coordinating with its European strategic manufacturing partners, including Switzerland’s Lonza and Spain’s Rovi, for manufacturing and fill-finish outside of the US.
The company intends to manufacture between 500 million and one billion doses in 2021. Moderna aims to start shipping mRNA-1273 to the European Union in December, if the relevant regulatory approvals are granted.
Recently, the independent and NIH-appointed Data Safety Monitoring Board (DSMB) revealed that the mRNA-1273 candidate has demonstrated an efficacy rate of 94.5% in the first interim analysis of phase 3 COVE study.
Moderna CEO Stéphane Bancel said: “We appreciate the confidence the European Commission has demonstrated in our mRNA vaccine platform by including mRNA-1273 in their portfolio of vaccines. We recognize that tackling this global pandemic will require a number of solutions, and we are proud of the role Moderna has been able to play in this global effort.
“We have scaled up our manufacturing capacity outside of the United States with our strategic partners, Lonza and Rovi, to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year beginning in 2021, if approved.”