Ireland’s medicines regulator has received a small number of reports associated with blood clots following vaccination with the AstraZeneca vaccine, but none of the nature seen in Norway.
The Health Products Regulatory Authority (HPRA) said on Sunday afternoon that there is currently no indication that vaccination was the cause of these events.
The authority confirmed it had not received any reports like those described by the Norwegian Medicines Agency, which reported four serious and rare blood clotting events, including some complicated by very low levels of platelets in the blood in younger adults after vaccination.
Ireland has temporarily suspended the use of AstraZeneca Covid-19 vaccines following new information received from the Norwegian Medicines Agency on Saturday evening.
“We will continue to monitor national reports very closely and continue to encourage the reporting of any suspected side effect following vaccination with a Covid-19 vaccine,” the HPRA said in a statement on Sunday afternoon.
Reports of potential safety concerns, even if very rare, are rigorously and swiftly investigated
“There is currently no indication that vaccination was the cause of these events, and there may be alternative explanations for their occurrence that are unrelated to the vaccine.
“However, the safety of the public is of the utmost importance, and it is essential that reports of potential safety concerns, even if very rare, are rigorously and swiftly investigated so that the public can be reassured and if required, appropriate action can be taken.”
Temporary and precautionary
The National Immunisation Advisory Committee (NIAC) has recommended that the administration of the AstraZeneca vaccine be deferred on a “temporary and precautionary” basis in Ireland.
The suspension is pending the outcome of an investigation underway at EU level into a small number of reports of thromboembolic or blood clotting events that occurred in patients who had recently received the vaccine.
The European Medicines Agency (EMA) on Thursday said the vaccine's benefits outweighed its risks and it could continue to be administered.
The number of blood clotting events in vaccinated people was no higher than the number in the general population, with 30 reports following the vaccination of close to five million people, a preliminary assessment from the EMA found.
AstraZeneca said an analysis of its safety data covering reported cases from over 17 million vaccine doses given had shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia – having low levels of platelets.
“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,” a company spokeswoman said.
Over 117,000 AstraZeneca vaccines have been administered in the Republic to date, about 20 per cent of the total.