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
Europe's drug regulator gave the green light to Moderna Inc's Covid-19 vaccine on Wednesday, the second shot it has approved, as authorities accelerate inoculation efforts amid fears about more infectious variants of the coronavirus.
Vaccinating the European Union's 450 million people could be crucial to ending a pandemic that has killed almost 1.9 million people globally. The approval comes as countries are racing to contain two variants found in South Africa and Britain that are more transmissible and have driven a surge in infections.
The EU's European Medicines Authority (EMA) said it had given the go-ahead for the use of the Moderna vaccine on people aged over 18 following an assessment of the data on quality, safety and efficacy.
The final step before it can be rolled out across the European Union is approval by the bloc's executive body, the European Commission, which is expected to follow soon.
The decision, coming just over a year since the first outbreak of the virus was identified in China, marks the second regulatory authorisation for Moderna's vaccine after the United States, and further validation of new genetic mRNA technology.
It was about 95% effective at preventing illness in clinical trials that found no serious safety issues.
The Dutch national drugs authority, the CBG, said the Moderna vaccine was expected to be effective against the mutated variant of the coronavirus detected in Britain, but cautioned this had to be confirmed by further research.
The CBG added that the European Commission was expected to give the final stamp of approval to the shot later on Wednesday.
The EU move follows the conditional marketing approval two weeks ago for a vaccine from Pfizer Inc and BioNTech SE, also based on mRNA technology.
The campaign to vaccinate the EU's population has gotten off to an uneven start, with officials in Germany and France frustrated at the slow rate of progress.
Hundreds of thousands of Europeans have received the shot since the rollout began a week ago. By comparison, Britain has administered more than a million of the Pfizer-BioNTech shots in just under a month.
The Netherlands on Wednesday started vaccinations with that vaccine, giving its first injection to a 39-year old care home nurse.