European drugs regulator approves Moderna coronavirus vaccine – statement

Moderna Inc’s coronavirus vaccine on Wednesday became the second to receive approval from Europe’s medicines regulator as authorities accelerate the roll-out of shots aimed at curbing the pandemic amid worries about more infectious variants.

Following the green light from the European Medicines Agency (EMA), the final step is approval by the European Commission which is expected to quickly follow. 

The CHMP called an unscheduled meeting on Monday to discuss Moderna’s vaccine but failed to reach a conclusion.

The EMA has set a Jan. 12 deadline for whether to recommend Moderna’s vaccine.

See full EMA statement on Moderna coronavirus vaccine approval here

It recommended a COVID-19 vaccine from Pfizer and its German partner BioNTech on Dec. 21.

The positive decision marks the second regulatory authorisation for Moderna’s vaccine after the United States and further validation of its messenger RNA technology, just over a year since the first outbreak of the virus was identified in Wuhan, China.

It was about 95% effective at preventing illness in clinical trials that found no serious safety issues.

Since its rollout in the European Union began a week ago, hundreds of thousands of Europeans have received the Pfizer-BioNTech vaccine.

More than a million shots have been distributed in Britain in just under a month, and the uneven start of the campaign has led to criticism of health authorities in Germany and France, among others.

The Netherlands on Wednesday start vaccinations, giving its first injection to a 39-year old care home nurse.

Main Photo: The Moderna COVID-19 vaccination at LAFD Station 4 in Los Angeles, California, USA. EPA-EFE/Gary Coronado / POOL