European Union agency authorizes Moderna's COVID-19 vaccine

Virus Outbreak Europe Vaccines
Posted at 9:36 AM, Jan 06, 2021

AMSTERDAM (AP) — The European Union’s medicines agency has given the green light to Moderna Inc.’s COVID-19 vaccine.

The decision gives the 27-nation bloc a second vaccine to use in the desperate battle to tame the virus rampaging across the continent. The same vaccine was approved in the U.S. on Dec. 18.

The vaccine was recommended by the European Medicines Agency’s human medicines committee, which must be rubberstamped by the EU’s executive commission.

The recommendation comes amid high rates of infections in many EU countries and strong criticism of the slow pace of vaccinations across the region of some 450 million people.

The EMA committee says it thoroughly assessed the data on the quality safety and efficacy of the vaccine before recommending its authorization.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of EMA. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO."

A EMA said in a press release that a trial of around 30,000 people showed the Moderna vaccine was effective at preventing COVID-19 in people 18 years and older. The vaccine demonstrated a 94.1% efficacy in the trial, which also showed 90.9% efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection.