AstraZeneca vaccine temporarily suspended as precautionary measure over reports of blood clots

Administration of the Astrazeneca vaccine has been temporarily suspended by the HSE on advice from the National Immunisation Advisory Committee (NIAC) this morning.

This comes following NIAC receiving “new information” from the Norwegian Medicines Agency yesterday of four reports of “serious blood clotting events in adults after vaccination with Covid-19 Vaccine AstraZeneca”.

In a statement from Deputy Chief Medical Officer Dr Ronan Glynn, he confirms the decision was taken in light of this new evidence and following discussions with the Health Products Regulatory Authority (HPRA).

The “temporary deferral” of the administration of the vaccine is effective immediately.

More than 117,000 doses of the vaccine have been administered in Ireland to date.

"The decision to temporarily suspend use of the AstraZeneca Covid-19 vaccine was based on new information from Norway that emerged late last night," Health Minister Stephen Donnelly said.

"This is a precautionary step. The National Immunisation Advisory Comm meets again this morning and we’ll provide an update after that."

Dr Glynn said this "action is based on a small number of reports of thromboembolic (clotting) events in people who received the AstraZeneca vaccine.

"The European Medicines Agency (EMA) has reviewed the available evidence and has stated that the benefits of this vaccine outweigh any potential risk and can continue to be used. The EMA is carrying out further detailed assessments.

"The UK regulatory body, MRHA, has reviewed data following use of 11 million doses of this vaccine in the UK and also recommended no change to its use in the vaccination programme.

"No change to NIAC’s recommendation on the use of the AstraZeneca vaccine is currently warranted. NIAC will continue to keep the situation under review."

“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,” Dr Glynn said.

NIAC is due to meet again this morning and a further statement will follow, Dr Glynn said.

In a statement, an AstraZeneca spokesperson said: “An analysis of our safety data that covers reported cases from more than 17 million 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.

“In clinical trials, no trends or patterns were observed with regard to pulmonary embolism, deep vein thrombosis, or events possibly related to thrombocytopenia.

“A careful review of all available safety data including these events is ongoing and AstraZeneca is committed to sharing information without delay. We also note that the European Medicine Agency (EMA) has asked for an assessment of events related to thrombocytopenia from other Covid-19 vaccine manufacturers (per communication 11 March).”

Other countries which have temporarily suspended the vaccine include Denmark, Iceland and Norway.

Three health workers in Norway who had recently received the AstraZeneca Covid-19 vaccine are being treated in hospital for bleeding, blood clots and a low count of blood platelets, Norwegian health authorities said on Saturday.

“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.

“They have very unusual symptoms: bleeding, blood clots and a low count of blood platelets,” Steinar Madsen, Medical Director at the Norwegian Medicines Agency told broadcaster NRK.

A number of other countries, including Italy, have temporarily stopped using two different batches of the AstraZeneca vaccine, after reports in Italy of a “serious adverse event” linked to one batch, and a death and illness in Austria related to another batch.

In a Thailand health ministry news conference, Prasit Watanapa, Dean of the Faculty of Medicine at Siriraj Hospital, confirmed the rollout would be delayed in the country.

In a statement following its meeting this morning the National Immunisation Advisory Commitee (NIAC) said that after a new safety alert from the Norwegian Medicines Agency received late on 13 March 2021, NIAC met with the HPRA and HSE representatives to consider this new information

A full committee meeting was held this morning.

It said the alert followed four new reports of serious, rare thromboembolic (clotting) events, including some complicated by thrombocytopenia (low platelet count) in adults under 65 years of age after vaccination with Covid-19 Vaccine AstraZeneca.

“To date, no reports of similar events have been received by the HPRA. Over 117,000 doses of Covid-19 Vaccine AstraZeneca have been given in Ireland.

“The European Medicines Agency (EMA) has been investigating a number of reports of clotting events following vaccination with Covid-19 Vaccine AstraZeneca. Further information is expected from the EMA in the next few days, which will include a review of the additional events.

“The possible relationship between these events and the Covid-19 Vaccine AstraZeneca is uncertain and is being investigated. It is very important that all potential rare events are rigorously and swiftly investigated so we can support public confidence.

“In light of this new information and pending receipt of further information from the EMA, on a precautionary principle it is recommended to temporarily defer administration of Covid-19 Vaccine AstraZeneca as of today, Sunday 14 March 2021.”

It said: “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.

“These rare events that have been reported have usually occurred within 14 days of the Covid-19 Vaccine AstraZeneca.”

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.”

In a fresh statement this afternoon the medicines watchdog, the Health Products Regulatory Authority, said it has received "a small number of reports associated with blood clots following vaccination with the AstraZeneca vaccine.

"However, it has not received any reports of the nature of those described by the Norwegian Medicines Agency. 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."

It said it is in continuous dialogue with the European Medicines Agency (EMA) and national medicines regulators across Europe in respect of the ongoing European review. The EMA, through its safety committee, PRAC, initiated an urgent review of all blood clotting events occurring with the AstraZeneca COVID-19 vaccine [11 March] to determine if there is a possible safety risk. As a member of PRAC, the HPRA is involved in the review of all cases of thromboembolic events, and other conditions related to blood clots, reported post-vaccination with the AstraZeneca Covid-19 Vaccine.

The NIAC made its recommendation following notification from the HPRA on Saturday, 13 March 2021, of a new safety alert regarding the vaccine.

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"This alert originated from the Norwegian Medicines Agency, following four new reports of serious, rare blood clotting events, including some complicated by very low levels of platelets in the blood in younger adults after vaccination.”

It said 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.

“The preliminary assessment of similar events published by the EMA on 11 March found the number of blood clotting events in vaccinated people was no higher than the number seen in the general population. As of 10 March, 30 cases of blood clotting events were reported in the EMA’s database of side effects following vaccination of close to 5 million people in the European Economic Area. A thorough analysis of all relevant reports will be performed, including those newly notified from Norway.

“As for all vaccines, it is possible to experience side effects and the majority of these are known to be mild to moderate. Anyone who may have a concern regarding their health following vaccination should consult their doctor or out-of-hours medical service. Additional advice for those who have been vaccinated has also been issued by the NIAC.”

The HPRA said it will continue to participate in the EMA review and engage with NIAC and the Department of Health on this matter.