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LAST UPDATE | 19 Mar 2021
THE NATIONAL PUBLIC Health Emergency Team (NPHET) has recommended that vaccinations with the Oxford/AstraZeneca vaccine should resume in Ireland following yesterday’s green light from the European Medicines Agency (EMA).
This paves the way for the HSE to resume administering the vaccine again this weekend.
The EMA reviewed the vaccine following a small number of blood clotting events that were reported following vaccinations but yesterday concluded that the vaccine was “safe and effective”.
Following those considerations, the use of the vaccine has been cleared for use again in Ireland after being paused last Sunday subject to the EMA’s review.
Announcing the decision, Deputy CMO Dr Ronan Glynn has now said that based on the findings by the EMA and NIAC, he has recommended the recommencement of vaccination with the AstraZeneca vaccine.
“The HSE will now work to recommence the administration of COVID-19 Vaccine AstraZeneca,” said Dr Glynn.
Professor Karina Butler of the National Immunisation Advisory Committee said:
“The safety of vaccines is paramount. The public should be reassured by the swift and thorough investigations into a very small number of serious but very rare adverse events.”
“Because COVID-19 can be so serious and is so widespread, the EMA found that the benefits of this vaccine outweigh the risks of these very rare events.
“The public should be reassured by the fact that over 20 million doses of this vaccine have been given in the EEA and the UK providing protection to those who have received it.
We are seeing that the rate of infections and hospitalisations are beginning to reduce amongst those who are vaccinated. The best vaccine that anyone can received is the one that they can get soonest.
Health Minister Stephen Donnelly welcomed the news, saying that vaccination with the AstraZeneca vaccine will resume over the weekend.
“Good news on the restarting of AstraZeneca. The HSE is this evening updating clinicians and the information leaflet and will be administering the vaccine this weekend, as well as the already planned vaccination activity,” said Donnelly in a tweet.
Good news on the restarting of AstraZeneca. The HSE is this evening updating clinicians and the information leaflet and will be administering the vaccine this weekend, as well as the already planned vaccination activity. pic.twitter.com/vg3LiClW9R
— Stephen Donnelly (@DonnellyStephen) March 19, 2021
In a statement this evening, HSE chief clinical officer Colm Henry welcomed the news.
He said: “We will now put in place the updated information and advice recommended by NIAC, and begin rescheduling vaccinations starting with a relatively modest number tomorrow.”
The HSE said the priority is to restart using the AstraZeneca vaccine in as safe and timely a manner as possible. For those who will be due to receive a second dose in a number of weeks time, the HSE said its strong recommendation is to receive a second dose when it is offered.
NIAC has recommended that the vaccine be used for everyone aged 18 and over, but Dr Butler said that currently, the previous rollout plans are unchanged.
This means that mRNA vaccines, like Pfizer or Moderna vaccines, will be used for the over 70′s age cohort, while AstraZeneca will be used in younger cohorts.
Ireland will follow a host of European countries that have also announced they will resume using the AstraZeneca vaccine.
French Prime Minister Jean Castex said the country will begin vaccinating people again with AstraZeneca vaccine from today, with Italy and Germany also expected to resume today.
However, France’s health authority announced earlier today that the AstraZeneca vaccine would only be used to vaccinate those aged 55 and over.
According to the health authority, it’s recommendation was based on the fact that the reports of blood clots that lead to the suspension of the vaccine were only seen in people aged under 55.
Spain, Portugal and the Netherlands said they will follow suit next week, although Spain said it could exclude certain groups.
In total, AstraZeneca has made up just over 20% of the 632,000 Covid-19 vaccine doses administered in this country.
Vaccine hesitancy
Asked about whether the AstraZeneca pause could affect confidence in the roll-out programme and increase vaccine hesitancy, Glynn said last night that he has “no doubt” that this is a challenge.
“I think the challenge for us and for those tasked with rolling out the vaccine is to make sure that people’s questions are answered clearly. I would hope that the majority of people, when they reflect on the past week, will see that we acted quickly and we acted in the context of putting safety first,” he said.
This evening, he also said that the best thing that Ireland can do is to get all the vaccines available out as quickly as possible.
“If I was offered any of these three vaccines right now, I would take it,” said Dr Glynn.
On vaccine choice, Dr Butler said that it would not be possible to offer people an alternative vaccine if they turned down one.
“If it was a situation where there were 10 different brands on the shelf, that would be a different situation.”
But the other thing is that we know that each of these vaccines is proven effective and very effective at preventing hospitalization and serious illness so we would strongly encourage everyone to accept the vaccine that they’re offered.
Speaking on RTÉ’s News at One this afternoon, Dr Lorraine Nolan of the Health Products Regulatory Authority (HPRA) said that their view was the same as the EMA’s, and that the AstraZeneca vaccine was safe.
“It’s really important here not to get too focused on these very small issues and to really focus on the benefits of vaccination,” said Dr Nolan.
“The reality is we need to vaccinate people and every vaccine has a place in our vaccination programme.”
According to Dr Nolan, the HPRA will be releasing additional safety reporting within the next week. Of 2,000 side effect reports released by the HPRA on the AstraZeneca vaccine, only seven were of blood clotting events.
However, Dr Nolan did clarify that these were not of a serious nature and were more common blood clots, like clots in the leg or the lungs.
Dr Nolan also said that it was possible that other medical reasons were causing them, rather than the AstraZeneca vaccine.
“In all of the cases when we have looked at them, there are very possibly other medical reasons that have contributed to the occurrence of the clots. Nothing unusual or concerning in those,” said Dr Nolan.
EMA
Head of the EMA, Dr Emer Cooke said yesterday at a media briefing that the benefits of the vaccine in protecting people from Covid-19, with the associated risks of hospitalisation or death, outweigh the potential risks.
As the link between the blood clotting events and the vaccine cannot be entirely ruled out, Dr Cooke says that the committee has recommended that awareness be raised about potential risks.
According to Cooke, this should be done by including details within product information that would equip medical professionals and people being vaccinated to “spot and mitigate any possible side effects”.
Investigations are also being launched by the EMA on a European level to understand more about the rare cases, with targeted investigational studies to take place.
“When you vaccinate millions of people it’s inevitable that rare or serious instances or illnesses will occur in the time immediately following vaccination,” Dr Cooke said yesterday.
Our role in the EU regulatory system is to rapidly detect these incidents and investigate whether there may be a link to the vaccine or whether they are the result of illnesses which occur by chance close in time to the vaccination.
“We are permitted to ensure that any new suspected adverse reactions are rapidly investigated to support decisions based on science, which can then support competence in vaccines which is so important in dealing with this devastating pandemic that we are facing, and we remain fully mobilised to ensure our public health.”
With reporting by Sean Murray, AFP
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They should of started jabbing again at 4.30 yesterday afternoon
@Karl Pinker: Hate to see the HSE robbing a bank. The car would be in the garage getting a service done instead outside the bank with the engine running.
@Joe Johnson: same with every public service. Not answerable to the bottom line like us running a proper business.
@Karl Pinker: They couldn’t. Each person now has to be given updated AZ vaccine wording by vaccinators to avoid litigation.
If we weren’t such a litigious country, we could have started yesterday at 4.30.
Germany and France to resume vaccinations today, ireland want to wait a few more days. Says it all.
@Uncle Montys oaf: but it’s the weekend.. and the sun’s out.. be grand.
@Shay Redmond.: they did 300 plus vaccines last Sunday….. its a day of rest in this country.
@Ian Forbes: If vital work has to be done, it does not matter what day or time of the day it is.
@Quia Timet: the numbers for Saturday, Sunday and Monday are low compared to rest of week !
@Quia Timet: I think you missed his sarcasm
@Ian Forbes: they did 660,000 today in the UK
@Ian Forbes: folks a colleague of mine in the UK his wife got qualified to give the AZ jabs and she did 76 on her first 12 hr shift last Sunday. There we 30 vaccinators in her sports hall in the middle of nowhere (relatively speaking) and cars came in and out in an orderly fashion and they did 3,000 on a Sunday !
Borris ffed up the initial handling but people over there think he is doing a good job, where our best boys in Europe locked up the country and messed up the vaccine rollout and will be remembered for it. Game changer my hole !
On the basis of the EMA’s approval?
It was never “unapproved” — the last week, even while the EMA was reviewing the reports, the EMA’s position was unambiguously to keep vaccinating people.
@Gerard: yep nphet and niac truly are our best and brightest.
@john s: As the comments are blocked on the previous article, due to legal reasons (my bruised plums), I’m commenting on here & will copy & paste in case it’s deleted. The Article is trial by media, holds no evidence apart from citing old gatherings where Professor Cahill was in attendance, and is one of the most one-sided things I have ever read. The article should be binned, and a synopsis posted as ‘Gards, with backing of Authorities, put squeeze on outspoken anti-lockdown campaigner’
There’s a reason why journalists were depicted as pigs on Spitting Image in the 80’s ….
@Martin Galvin: The story has been taken down …. Job done. Cheers.
@Martin Galvin: Take it down, please …. Shifting it down a few notches doesn’t validate it ….
@Martin Galvin: Seen it this morning too.
The European Medicines Agency approved the continued use of the vaccine yesterday. Approval by our NIAC was therefore only a formality but it should have come within minutes of the EMA decision yesterday, not late this afternoon. One can only conclude that the delay was down to grandstanding by the NIAC and it is inexcusable. Yet another sorry chapter in our omnishambles of a vaccination rollout.
Took long enough
@Adrian O’Donnell: were lucky you’re not in charge
@Adrian O’Donnell: damage is done already
So a load of horse s—t waiting around afraidbto make a decision itvwas approved yesterday just get on with it for God sake pull your finger out your A—e and just do it
@Michael Fleming: It was never unapproved. EMA never suspended their approval. Ireland and a few other countries unilaterally suspended the vaccine. Fear of litigation (even though the risk from suspending vaccines was probably greater, for the obvious reason and also because Covid can cause clots )
@Thomas O’ Donnell: I never said it was unapproved I was saying that it had been cleared 24 hrs ago so why do we hace to wait? Is it because the establishment want to give the nod to show us who is in charge . The vaccine role out has been nothing should of a shambles since the start and needs to be moved on as quickly as possible without any delays
It’s gonna take day to resume..??? Donnelly needs to go. Put the vaccination programme in the hands of the army, they know how to deal with logistics and crisis management…
Mood in the country seriously low at this point. I don’t blame Dr Ronan Glynn for the situation, what he communicated was all wrong though. I’m sure the majority of us would keep going if we the Government and NPHET had an endgame but the lack of goodwill and information is forcing people to give up.
@Oliver Walker: I and many more blame Glynn
@Oliver Walker: so he is wrong maybe u would do a better job
7 blood clotting events, out of over 20 million doses administered…..how did we ever stop!?!?!
Why haven’t we started immediately, tonight, tomorrow morning!!
They found the cause & treatment for the issue according to WSJ
- Pål André Holme, a professor of hematology and chief physician of the Oslo Hospital who headed an investigation into the Norwegian cases, said his team had identified an antibody created by the vaccine that was triggering the adverse reaction.
- German researcher Andreas Greinacher, professor of transfusion medicine at the Greifswald University Clinic, said they had independently came to the same conclusion as Prof. Holme.
- Patients who show symptoms four days after vaccination, such as headaches, dizziness or impaired vision, could be quickly diagnosed with a blood test.
- Once diagnosed, the condition should be treated with blood thinning medication and immunoglobulin, which targets the antibody that causes the problem.
@C…: if one of those 7 was your son, daughter, mother, would you say the same thing??
Next up.. NIAC give their tips for Cheltenham festival 2021
We should be vaccinating 24/7 to catch up.
Why Days before clinics set up when the halt was just a precautionary halt and always going to resume from the data coming in days ago . Why this next delay now . We really need to get speed of urgency before a last straw occurs to undo all the hard work by so many in waiting since January for a speedy roll out .
So a new information sheet must come with the AZ. So they are telling you on one side of the page it’s safe on the flip side its dangers, I personally think they need to have a new retrial with all age groups that’s if they can get people to do it. Massive damage has being done to this jab and once trust is lost its not easy to get it back.
@Thomas Armstrong: Tell me one medicine that doesn’t come with an information sheet which details the side effects. The problem is there are people with no scientific understanding whatsoever that latch on to side effect or incidences that happen by coincidence with no causal link. If the pharmaceutical companies tell them everything then they make a big deal out of nothing, if they don’t tell them everything it’s a big conspiracy. It’s not public perception that’s the problem, it’s public education.
@Thomas Armstrong: hmm a retrial – you do realise that 20 millions doses already given to people is a far more significant than any retrial ….
@Diarmuid Hunt: Never read the leflet about side effects. Then you’ll suffer from all of them!!
It’s a wonder there wasn’t a working group set up to make a decision on it in two weeks time
They did close to 660,000 vaccinations today in the UK apparently… in one day.
@Michael O’Connor: that’s our total since the beginning of the rollout. An inept government . Unable to provide for it’s citizens. Are we surprised?
@Michael O’Connor: 1% U.K. adult population… in one day
Yeah all 10 doses that they do have
At last
EU handling of the vaccine rollout is tantamount to digging yourself a hole but, rather climbing out, they just keep digging
Need to start vaccinating again ASAP
Was is everything in this country so slow
Pop an aspirin 10 minutes before. Sorted.
i wont be taking anything prescribed by a government.
@plug: I hope you like cold rainy islands
France only giving it to over 65
@Úna O Connor Barrett: over 55’s
Wooohoooo Party Party Party!!!!!
Woo!…god long will this take
Thanks NIAC. You’re a star..
The t-shirt should get off his #ole now and stop making excuses
Wow, didn’t expect that outcome
Which Monday?
I work where the vaccine is stored and shipped out and I can’t even get it.
I hope NPHET checked with all The Journal comments section and Twitter experts before they issued their recommendation.
have your say