The National Immunisation Advisory Committee (NIAC) has recommended that the administration of the AstraZeneca Covid-19 vaccine be temporarily suspended from this morning.
In a statement, Dr Ronan Glynn, Deputy Chief Medical Officer (CMO), said the recommendation was being made following a report from the Norwegian Medicines Agency of four new cases of serious blood clotting events in adults after receiving the Covid-19 AstraZeneca vaccine.
Dr Glynn said the NIAC is acting on a "precautionary principle" as it has not yet been confirmed that there is any link between the AstraZeneca vaccine and these cases.
A spokesperson for AstraZeneca said a careful review is ongoing and it is committed to sharing information "without delay".
The spokesperson said an analysis of its safety data that covers reported cases from more than 17m doses of vaccine administered “has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia with Covid-19 vaccine AstraZeneca.”
“In fact, the reported numbers of these types of events for Covid-19 vaccine AstraZeneca are not greater than the number that would have occurred naturally in the unvaccinated population,” the spokesperson said.
As of last Wednesday, over 109,000 doses of the AstraZeneca vaccine have been administered in Ireland, representing almost 20% of all doses given here to date.
Chair of NIAC, Professor Karina Butler said: “This is a precautionary move. We will continue to monitor the situation and if we can be satisfied that these events are coincidental and not caused by this vaccine we will reassess the situation."
“This vaccine is proven to be very effective against severe Covid-19 disease, which is associated with a risk of clotting events. We have taken this step out of an abundance of caution," she said.
Prof Butler said the “cluster of four serious, very rare, very serious clotting events" are "not the kind of the usual clots in the legs but actual clots involving the brain or vessels that would normally be involved and in younger people,” she told the
.“So, looking overall it was a number of these very small but very rare serious events in people that you might not otherwise expect it that raised a signal, a safety signal.”
Prof Butler said that hopefully next week she would be in a position to inform people that the AstraZeneca vaccine is safe to use going forward, but at the moment they had "serious concerns" that they needed reassurance on.
The Royal College of Physicians of Ireland has advised that: "In the rare event that someone who has received the Covid-19 Vaccine AstraZeneca feels increasingly unwell more than three days after vaccination, and/or who notices larger or smaller blue spots in the skin (purpuric, non-blanching rash, skin haemorrhages) they should consult their doctor or out-of-hours medical service.
It noted that these rare events that have been reported have usually occurred within 14 days of the AstraZeneca vaccine being administered.
Norway had halted the rollout of the AstraZeneca vaccine on Thursday, following a similar move by Denmark over concerns. Iceland later followed suit.
Norwegian health authorities said on Saturday that three health workers who had recently received the AstraZeneca 19 vaccine were being treated in hospital for bleeding, blood clots and a low count of blood platelets.
All three individuals were under the age of 50.
“We do not know if the cases are linked to the vaccine,” Sigurd Hortemo, a senior doctor at the Norwegian Medicines Agency told a news conference held jointly with the Norwegian Institute of Public Health.
The European medicine regulator, the European Medicines Agency (EMA,) would investigate the three incidents, Hortemo said.
Before Denmark and Norway halted their rollout of the AstraZeneca vaccine, Austria stopped using a batch of the shots while investigating a death from coagulation disorders and an illness from a pulmonary embolism.
The World Health Organization has also said that no causal link had been established between the vaccine and blood clotting.
The EMA said on Thursday the vaccine’s benefits outweighed its risks and that it could continue to be administered.