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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