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Vaccine latest HSE temporarily suspends AstraZeneca vaccine as precautionary measure over reports of blood clots

It 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”.

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The Astrazeneca vaccine's use has been suspended effective immediately.

The Astrazeneca vaccine's use has been suspended effective immediately.

The Astrazeneca vaccine's use has been suspended effective immediately.

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.

He 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 response to questions from Independent.ie on Friday the HPRA, the medicines watchdog said "the EMA, through its safety committee, PRAC, has initiated a review of thromboembolic events that have occurred following administration of the AstraZeneca Covid-19 vaccine, as part of its close safety monitoring.

“An initial EMA assessment (update issued yesterday March 11) has established that the number of thromboembolic events in vaccinated people is no higher than the number seen in the general population. As of 10 March 2021, 30 cases of thromboembolic events had been recorded on the EMA’s database of side effects among close to 5 million people vaccinated with Covid-19 Vaccine AstraZeneca in the European Economic Area.

“The position of EMA’s safety committee PRAC is that the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing.

“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 Covid-19 Vaccine AstraZeneca.

"Whilst the number of thromboembolic (blood clot) events reported in vaccinated people is no higher than that seen in the general population, it is very important to scrutinise swiftly any reports of potential safety concerns, even if very rare, so that appropriate action if required can be taken.

"The HPRA is working closely with the EMA and with national bodies here in Ireland and will further communicate as the assessment progresses.

“In relation to the specific batch suspended in Austria, this was supplied to 17 countries in the EU including Ireland. The HPRA is aware that this batch was last distributed for use nationally during the second half of February. No further supplies from this batch are expected.

“The HPRA have received a small number of reports associated with blood clots following vaccination with the AZ vaccine, however, the nature of the reports has not raised a concern. These reports have been communicated to the EMA and will be included in an ongoing review.”

More to follow..


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