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Moderna Aims For Emergency Authorization For Coronavirus Vaccine Candidate In December

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Moderna Aims For Emergency Authorization For Coronavirus Vaccine Candidate In December

Moderna Inc (NASDAQ: MRNA) shares were moving to the upside Tuesday after the company committed to a timeline for an interim readout for its coronavirus vaccine candidate — and application for emergency use authorization.

What Happened: Interim results from the Phase 3 COVE study are expected in November, and if they're positive, the vaccine candidate mRNA-1273 could succeed in obtaining emergency use authorization in December, Moderna CEO Stephane Bancel told The Wall Street Journal at the publication's annual Tech Live conference.

The first analysis is likely to come in November, he said. 

"It's hard to predict exactly which week because it depends on the cases, the number of people getting sick," the CEO reportedly said. 

If the interim results are delayed, authorization for emergency use may not be obtained until early next year, the report said.

Related Link: The Week Ahead In Biotech: Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference

What's Next: Over 98% of the targeted enrollment in the coronavirus vaccine study is now complete.

Moderna has also applied to initiate a rolling submission for marketing approval in Europe and Canada

Moderna shares were higher by 0.63% at $71.40 at last check Tuesday.

Related Link: Moderna Analyst On Why Coronavirus Vaccine Developer's Stock Is Long-Term Attractive

 

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