Ireland has temporarily suspended the use of AstraZeneca Covid-19 vaccines following new information received from the Norwegian Medicines Agency on Saturday evening.
The Health Products Regulatory Authority (HPRA) and the National Immunisation Advisory Committee (Niac) recommended that the administration of AstraZeneca vaccine be “temporarily deferred” from Sunday morning.
Dr Ronan Glynn, the deputy chief medical officer, said: “This recommendation has been made following a report from the Norwegian Medicines Agency of four new reports of serious blood clotting events in adults after vaccination with Covid-19 Vaccine AstraZeneca.
“It has not been concluded that there is any link between the COVID-19 Vaccine AstraZeneca® and these cases. However, acting on the precautionary principal, and pending receipt of further information, the NIAC has recommended the temporary deferral of the COVID-19 Vaccine AstraZeneca vaccination programme in Ireland.”
To date, no reports of similar blood clot events in Ireland have been received by the HPRA.
The European Medicines Agency (EMA) has been investigating a number of reports of clotting events following vaccination with the AstraZeneca jab. Further information is expected from the EMA in the next few days.
Niac is due to meet again on Sunday morning to discuss the issue.
The decision to temporarily suspend use of the AstraZeneca Covid-19 vaccine was based on new information from Norway that emerged late last night. This is a precautionary step. The National Immunisation Advisory Comm meets again this morning and we’ll provide an update after that
— Stephen Donnelly (@DonnellyStephen) March 14, 2021
Chair of Niac, Prof 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. The HPRA will keep NIAC fully informed as the EMA investigation progresses and we will keep you updated”.
“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.”
Over 117,000 AstraZeneca vaccines have been administered in the Republic to date, about 20 per cent of the total.
On Saturday, Norwegian health authorities said three health workers who recently received the AstraZeneca vaccine against Covid-19 are being treated in hospital for bleeding, blood clots and a low count of blood platelets.
Norway halted on Thursday the rollout of the vaccine, following a similar move by Denmark. Iceland later followed suit.
“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.
All three individuals were under the age of 50.
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.
Such trends or patterns were also not observed during clinical trials for the vaccine, she added.
The EMA on Thursday said the vaccine's benefits outweighed its risks and could continue to be administered. – Additional reporting: Reuters