LAST UPDATE | 21 Dec 2020
THE EUROPEAN UNION has given official approval for the Pfizer/BioNTech Covid-19 vaccine to be put on to the market across the EU.
Earlier today, the European Medicines Agency (EMA) recommended the vaccine for approval in the EU, paving the way for people in Ireland to begin receiving the vaccine.
European Commission president Ursula von der Leyen said the commission “took the decision to make available for European citizens the first Covid-19 vaccine. We granted conditional market authorisation”.
The commission had been expected to require two or three days to endorse the market authorisation move.
Deliveries of the vaccine had been pencilled in to start this Saturday, with vaccinations beginning across the EU between December 27-29.
Health Minister Stephen Donnelly said this approval of the first vaccine in the EU is a “huge achievement by our medical and scientific communities”.
“Within the coming days, we will begin administering this vaccine in Ireland,” Donnelly said.
“The most vulnerable will be prioritised first and over time, these vaccines will allow us to re-open our society and economy. In the meantime, I am asking everyone to continue to follow the public health guidance.”
An early Christmas present for us all - the first Covid vaccine has been approved in the EU after passing rigorous safety and efficacy tests. Vaccine roll-out will begin very shortly in Ireland. More info:https://t.co/UNZdnkQubb
— Stephen Donnelly (@DonnellyStephen) December 21, 2020
HSE CEO Paul Reid said this development “offers some hope at the end of what has been a very tough year for many people”.
However, he added that people should “keep in mind that the vaccine is not our first line of defence against Covid-19 for now, nor will it be for some time to come”.
“Recent events have shown us how quickly this virus can spread and how devastating that can be for our loved ones,” Reid said.
“We’ve seen how quickly an increase in cases can translate to illness, to pressures in our hospitals and to pressures in Intensive Care Units. For now everyone in Ireland should focus on maintaining the prevention and protective actions that have become part of how we are all working and living.”
Rigorous evaluation
In a statement, the EMA said it had completed a rigorous evaluation of the vaccine and that its analysis of the data had concluded “by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation”.
EMA executive director Emer 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. 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.
The EMA also said today that there’s no evidence that the vaccine won’t work against the new strain of Covid-19 being reported from England.
Last week, the government said that the granting of a marketing authorisation for the Pfizer/BioNTech vaccine today could mean the first vaccinations will take place in this jurisdiction before the new year.
Vaccine taskforce chief, Professor Brian MacCraith, said that following the approval it is expected to take 7-10 days for the first doses of Ireland’s allocated 2.2 million Pfizer/BioNTech vaccines to be delivered.
The first people to be vaccinated under the national strategy here are to be long-term care home residents over the age of 65, followed by frontline healthcare workers in direct patient contact.
Reacting to the news, Health Products Regulatory Authority CEO Lorraine Nolan said the accelerated approval process wouldn’t compromise important standards to ensure the vaccine is both safe and works effectively.
“There’ll be no lowering of the bar on this,” she said.
She added that vaccines will “serve as just one additional measures in our continued fight against Covid-19″.
.@EMA_News have recommended granting a conditional marketing authorisation for the #COVID19Vaccine Comirnaty, developed by BioNTech/Pfizer. @TheHPRA Chief Executive Lorraine Nolan outlines the regulatory process and why vaccines are safe pic.twitter.com/C4ihUoEzQw
— Department of Health (@roinnslainte) December 21, 2020
“Other public health recommendations, including handwashing, mask-wearing and social distancing, will continue to be vital to tackling this pandemic,” Nolan said.
The recommendation for approval for the vaccine by European authorities comes after regulators in the UK, US and Canada also approved the vaccine.
British Prime Minister Boris Johnson said this evening that more than half a million people in the UK have already received the first dose of the vaccine.
Data
In announcing its decision today, the EMA said that a very large clinical trial of the vaccine had found it was effective at preventing Covid-19 in people aged 16 and over.
The trial involved 44,000 people in total – half received the vaccine and half were given a placebo. People on the trial didn’t know which one they were receiving. The test for efficacy was calculated from over 36,000 who had no sign of previous infection.
The study showed a 95% reduction in the number of symptomatic Covid-19 cases in the people who received the vaccine (eight cases out of 18,198 who received the vaccine got Covid-19 symptoms).
This compared with people who received the dummy injection (162 cases out of 18,325 got Covid-19 symptoms).
The trial also showed around 95% efficacy in the participants at risk of severe Covid-19, including those with asthma, chronic lung disease, diabetes and high blood pressures.
The high efficacy was mirrored across genders, racial and ethnic groups.
The vaccine is given as two injections, at least 21 days apart. Common side effects reported were said to be mild or moderate, and people usually felt better within a few days after vaccination. They include pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever.
The EMA said it will continue to monitor the safety and effectiveness of the vaccine as it used across EU member states.
The regulator has been under huge pressure to speed up the process with governments led by Germany asking why Britain and the United States were able to authorise the vaccine sooner.
It said the delay was because a conditional marketing authorisation is more thorough and lasts longer than the emergency authorisation used by London and Washington.
Cooke said the agency had “worked night and day” to speed things up, but needed to make sure the Pfizer-BioNTech vaccine was safe and effective, in order to avoid any doubts that could affect uptake.
A decision on another vaccine produced by US firm Moderna is due by 6 January. Ireland has secured 880,000 doses of this vaccine.
With reporting by Press Association.
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