EMA: Moderna eligible for Marketing Authorization

Wednesday, 14. October 2020 14:26

Moderna Inc. has been deemed eligible to submit a Marketing Authorization Application to the European Medicines Agency (EMA) for its COVID-19 vaccine candidate, the company unveiled on Wednesday.

The submission came after encouraging results from the vaccine trial's Phase 1, the company noted and added that its manufacturing partners in Europe will be Swiss Lonza Ltd and Spanish Laboratorios Farmaceuticos ROVI SA.

"We are committed to developing a safe and effective vaccine following the guidance of regulatory agencies and we will continue our ongoing dialogue with the EMA. Moderna is scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021," the firm's CEO Stephane Bancel said.

Moderna's shares rose by 2.12% in the premarket, after the news, selling for $79.95.

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