The European Medicines Agency (EMA) said it has approved 'conditional authorisation' for a coronavirus vaccine for the European Union.
The announcement was made at the agency's headquarters on Monday afternoon in Amsterdam.
The executive director of the EMA, Irish woman Emer Cooke, said she was "delighted" to announce the "historic scientific" achievement.
This gives the potential green light to the Pfizer/Biontech drug, which will be valid in all EU member states at the same time.
Health Minister Stephen Donnelly also welcomed the news, which will now go to the European Commission for approval on Tuesday.
Great news from @ema_news - it has recommended authorisation of the first Covid vaccine in the EU. Now we wait to see if the European Commission approves it tomorrow. https://t.co/eZ6fIDl1Jz
— Stephen Donnelly (@DonnellyStephen) December 21, 2020
The EMA has recommended granting a conditional marketing authorisation for the vaccine in people from 16 years of age.
The EMA's human medicines committee - CHMP - completed a rigorous evaluation of the drug, and concluded that "sufficiently robust data on the quality, safety and efficacy of the vaccine" are available to recommend a formal conditional marketing authorisation.
However no timeframe has been set out by the EMA.
'An important step'
Ms Cooke said: "Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many.
"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."
She added: "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".
Who gets it and when?
Earlier this month, the Cabinet signed off on a plan to place nursing home staff and residents at the top of the queue for the vaccine.
The COVID-19 Vaccine Allocation Strategy included 15 phases for the rollout.
The first phase will see the job offered to everyone living in a long-term care facility who is over the age of 65.
The first phases noted that all residents and staff on-site should be considered for vaccination at this stage.
Frontline healthcare workers who are in 'direct patient contact' will be offered the jab in the second phase, with those aged 70 and over included in the third.
The 15-phase rollout is as follows:
- Residents of long-term care facilities over the age of 65. All residents and staff on-site should be considered for vaccination
- Frontline healthcare workers in direct patient contact roles
- People aged 70 and older
- Remaining frontline healthcare workers
- People aged 65 to 69-years-old
- Key workers providing services "essential to the vaccination programme"
- People aged 18 – 64 with underlying health conditions
- Residents of long-term care facilities aged between 18 and 64
- People aged between 18 and 64, living or working in crowded places
- Key workers who can’t avoid a high risk of exposure to COVID-19 (food supply, public transport etc)
- Primary and secondary school staff
- People aged 55 to 64
- Those in "occupations important to the functioning of society" – including those working in entertainment and third-level institutions.
- People aged 18 to 54-years-old
- Children, teenagers and pregnant women
A very large clinical trial, of around 44,000 people, showed that the jab was effective at preventing COVID‑19 in those from 16 years of age.
The study showed a 95% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine, compared with people who received a dummy injection.
The trial also showed around 95% efficacy in the participants at risk of severe COVID-19 - including those with asthma, chronic lung disease, diabetes, high blood pressure or a high body mass index.
The vaccine is given as two injections into the arm, at least 21 days apart.
The most common side effects were usually mild or moderate and got better within a few days after vaccination.
They included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever.
The EMA added that the safety and effectiveness of the vaccine "will continue to be monitored as it is used across the member states".
An assessment report, with details of EMA’s evaluation, will be published within days.
And clinical trial data submitted by the company in the application process will also be published in due course.
This story has been updated. For the latest version, click here