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EMA Committee Recommends Conditional Approval Of Moderna's Coronavirus Vaccine

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EMA Committee Recommends Conditional Approval Of Moderna's Coronavirus Vaccine

Moderna Inc (NASDAQ: MRNA) is close to getting its fourth regulatory nod for mRNA-1273, its vaccine candidate against SARS-CoV-2.

What Happened: The European Medicines Agency's Committee for Medicinal Products for Human Use, which met Wednesday, recommended that the agency grant conditional marketing authorization for mRNA-1273 in people, ages 18 years and older.

"EMA's human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission," the statement read.

A CHMP meeting Monday had ended without any decision.

Moderna's investigational vaccine has already been authorized for emergency use in the U.S. and U.K. and Israel.

The European drug regulator said it will closely monitor data on safety and effectiveness of the vaccine, as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and by European authorities.

Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates

European Commission president Ursula von der Leyen termed the development as good news in a tweet and said the EU is now working at full throttle to approve Moderna's vaccine candidate and make it available in the region.

Why It's Important: The EU has already approved for emergency use the vaccine candidate developed by Pfizer Inc. (NYSE: PFE)-BioNTech SE – ADR (NASDAQ: BNTX).

Moderna's vaccine candidate could help the union cover a majority of its population. The EU has a contract with the company to receive 160 million doses.

What's Next: The European Commission will now decide on granting conditional approval, taking into consideration the recommendation by the CHMP.

An assessment report with details of EMA's evaluation of COVID-19 Vaccine Moderna, and the full risk management plan, will be published within days, the agency said.

In premarket trading Wednesday, Moderna shares were rising 3.26% to $112.74.

 

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