Moderna Announces the European Commission Has Authorized their COVID-19 Vaccine in Europe

Rapid Unit Sales of Medical Masks to Account for Incremental Revenues in the Global Market Through the COVID-19 Crisis Period

Medical facilities are highly dependent on the use of medical masks during surgeries. The availability of different versions of mask for different applications across different end-users, such as ambulatory surgical centre’s, hospitals, dental settings, etc., are expected to fuel the growth of the medical mask market throughout the forecast period.

Proximie Raises $38m Series B Funding To Accelerate Its Expansion in U.S. and European Markets

F-Prime Capital led financing, joined by Questa Capital, Eight Roads, and Maverick Ventures

RhoVac Reports to Mount Sinai Hospital in New York Join Phase IIb Study in Prostate Cancer

The participation of Mount Sinai was directly caused by the FDA approval of RhoVac's Fast Track Designation.

January 6, 2021

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.

Moderna notes the authorization is based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.

“I want to thank the European Commission for its engagement and endorsement and the EMA for its recommendation, which is another significant moment in our company’s history,” said Stéphane Bancel, Chief Executive Officer of Moderna. “The EMA and the Committee for Medicinal Products for Human Use reviewers, working over the holidays, provided a thorough review and comprehensive guidance as we worked together to achieve this authorization. I am proud of the role Moderna has been able to play globally in helping to address this pandemic.”

The European Union is the fourth jurisdiction to authorize Moderna’s COVID-19 vaccine, following the United States on December 18, 2020, Canada on December 23, 2020 and Israel on January 4, 2021. Additional authorizations are currently under review in Singapore, Switzerland and the United Kingdom.

On December 18, the EMA exercised its option to increase its confirmed order commitment by 80 million doses of Moderna’s vaccine against COVID-19, bringing its confirmed order commitment to 160 million doses. The first deliveries of COVID-19 Vaccine Moderna to European countries from Moderna’s dedicated non-U.S. supply chain are expected to begin next week.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for COVID-19 Vaccine Moderna based on the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30.

 

spot_img

DON'T MISS

Related Articles