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Use of the AstraZeneca vaccine against Covid-19 is to resume on Saturday after the Government accepted expert advice giving it the all-clear for all adults.
The Health Service Executive is working on plans to reintegrate the vaccine into the overall immunisation rollout after a one-week suspension sparked by safety concerns.
The plan is for some small-scale use of the vaccine on Saturday and Sunday, with the number of doses administered increasing into next week.
The National Immunisation Advisory Committee (Niac) has recommended to the Department of Health that use of the vaccine be restarted, according to Dr Ronan Glynn, deputy chief medical officer.
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Niac met on Thursday evening and Friday after the European Medicines Agency (EMA) found there was no causal link between the vaccine and blood-clotting events reported in some European countries.
On Thursday, the EMA found the benefits of the vaccine in combating the threat of Covid-19 continued to outweigh the risk of side effects. It also concluded that the vaccine is not associated with an increase in the overall risk of blood clots in those who receive it.
Based on the committee’s recommendation, Dr Glynn said he had recommended the recommencement of use of the vaccine.
The HSE will now restart the programme using AstraZeneca, he told a briefing on Friday evening.
The vaccine can be used by all aged 18 and over, Niac recommended, and healthcare professionals should be informed that very rare, complicated clotting events have been reported in a small number of people who have recently received it.
“Healthcare professionals should be alert to the signs and symptoms of blood clots and/or low platelet count and report any suspected adverse reactions to the Health Products Regulatory Authority (HPRA),” it said
Recommendations
Anyone who gets the vaccine is recommended to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling and/or persistent abdominal pain within weeks of vaccination.
“Additionally, anyone with neurological symptoms including severe or persistent headaches (particularly 3 days after vaccination) or blurred vision after vaccination, or who develop skin bruising beyond the site of vaccination, should seek prompt medical attention.”
“These rare events have usually occurred within 14 days of receiving the AstraZeneca vaccine, particularly 3 days or more after.”
Ireland "temporarily deferred" use of AstraZeneca last weekend after a report from the Norwegian Medicines Agency of cases of serious, rare thromboembolic (clotting) events, including some complicated by low platelet counts. Some of the cases were fatal.
Defending the decision to suspend use of the vaccine, Niac chair Prof Karina Butler said until this happened officials had “no idea” of the frequency of the events being reported. The clustering of events and the severity of outcomes in Norway had given rise to the pause.
It seemed the rate at which events were being reported was increasing, until the EMA established the risk was about one in a million, she said.
To date, no reports of serious clotting events of this type have been received by the HPRA in Ireland. Over 129,000 doses of the vaccine have been administered in Ireland.
Separately, Dr Glynn apologised to anyone who felt frustrated, angered or “at the end of their tether” over his comments on Thursday, when he asked people to “do a little bit more” to avoid a fourth wave of the virus.
But he urged them to look at the entirely of what he had said at the National Public Health Emergency Team briefing. “The theme was of gratitude to the millions of people who compiled with public health measures.”
Unfortunately despite having made good progress and doing better than any other European country, Ireland remained in a “precarious” position. We need to “get through” April and May to get to a brighter future, he said.
Stroke
Earlier a stroke expert said there is a “substantially higher” risk of having a stroke through Covid-19 than from taking the AstraZeneca vaccine.
Prof Joe Harbison, who is clinical lead of the Irish National Audit of Stroke, told RTÉ radio’s Morning Ireland that “1 to 2 per cent” of people hospitalised with Covid during the first wave suffered stroke.
“We’re also seeing more large-vessel strokes occurring in young people with Covid. It’s one of these hidden complications of Covid that really hasn’t been much publicised.”
Prof Harbison said the AstraZeneca vaccine was “pretty clearly safe” with “less than a one in a million chance of developing a problem.”
“The reason they are concerned is this type of clot is a reasonably uncommon clot and that’s occurring in the brain and it can occasionally result in stroke – it doesn’t always result in stroke. It can be associated with stroke in younger people, but it has to be emphasised the risk of stroke from catching Covid-19 is substantially higher than the risk of developing any problem with the vaccine.
“If they were to offer it to my family, I would say yes take it. It’s much better to get the vaccine to be safe than risk Covid, which can give you much more unpleasant side effects.”
The chief executive of the HPRA, Dr Lorraine Nolan, said it was her view that the AstraZeneca vaccine was “absolutely safe” and should be used in Ireland.
“The reality is we need to vaccinate people and every vaccine has a place in our programme,” she told RTÉ radio’s News at One.
The very clear conclusion of the EMA was that AstraZeneca was a safe vaccine, she said.
Dr Nolan said it was important not to focus on small issues when there were still so many fatalities from Covid-19.
She said there had been 25 cases of blood clotting out of 20 million doses of the AstraZeneca vaccine.