''It is a significant step forward in our fight against this pandemic.''
The European Medicines Agency (EMA) has approved the Pfizer/BionTech Covid-19 vaccine has been approved for use across the EU.
The EMA says the jab has met its standards for quality, safety and efficacy.
Ireland is set to get over 2 million doses of the vaccine, and the rollout here is due to start by next Tuesday at the latest.
Today's decision follows trials involving more than 40 thousand people.
Emer Cooke, executive director of the EMA, said it's a major step in the right direction:
''It is a significant step forward in our fight against this pandemic which is causing suffering for so many people not just in Europe, but all over the world'', she said.
''This is really a historic scientific achievement, within less than a year a vaccine will have developed and authorised against a new disease''.
“We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States.
“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.”
It's expected to be at least seven days before the first shipments of vaccine will be available in Ireland, with long-term care home residents over the age of 65 the first people to be vaccinated under Ireland's vaccination plan.