More than 30,000 face vaccine deferral as State suspends AstraZeneca use over clotting fears

Government to await outcome of EMA investigation before deciding on future use of vaccine

The Government will await the outcome of an investigation by the European Medicines Agency (EMA) before deciding whether it should resume vaccinations with the AstraZeneca vaccine.

On Sunday the Government announced it was suspending use of the AstraZeneca vaccine after concerns emerged in Norway about blood clots in patients who had received the vaccine. The move is another blow to the vaccination programme, already suffering from missed deliveries and a slower-than-expected rollout.

Minister for Health Stephen Donnelly said the Government would await the assessment of the EMA on Thursday before taking advice from its own experts on the future use of the vaccine.

Hospital Report

The Government was acting out of an “abundance of caution”, he said, but it means about 30,000 people who were due to receive the AstraZeneca vaccine this week may miss out.

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In the longer term, it could impede plans to vaccinate the entire adult population by September. AstraZeneca has accounted for only a fifth of doses administered so far, but was expected to play a greater role as supplies improved.

Mr Donnelly said missed vaccinations could catch up in the coming weeks if use of the vaccine were re-authorised quickly.

To date, 120,000 people have received a dose of the AstraZeneca vaccine in Ireland.

Once the EMA has considered the reports, the Irish authorities – the Health Products Regulatory Authority (HPRA) and the National Immunisation Advisory Committee (Niac) – will advise the Government.

Clotting events

Niac met until 2am on Sunday morning after receiving a new safety alert about four reports of serious clotting events in Norway after vaccination with the AstraZeneca vaccine.

Having given the vaccine the all-clear just two days earlier over clotting cases in other European countries, committee members changed their stance due to the serious nature of the Norwegian cases and the fact they involved younger people, aged under 65.

Anyone who feels unwell for more than three days after receiving the AstraZeneca vaccine, or who notices blue spots on the skin, is advised to consult a doctor.

"This is a precautionary move," said Prof Karina Butler, chairwoman of Niac. "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."

As a result of the decision, 40 per cent fewer vaccine doses will be administered this week; those affected include up to 20,000 high-risk people with health conditions and as many as 10,000 healthcare workers who were due to receive the AstraZeneca vaccine.

About 50,000 Pfizer vaccines will still be administered, mostly to older people.

UK proceeds

In the UK, which has administered 11 million AstraZeneca doses, the regulator said the evidence did not suggest it was the cause of blood clots and it would continue to be administered.

AstraZeneca said an analysis of safety data covering more than 17 million doses of the vaccine administered had shown no evidence of an increased risk of the conditions concerned, and no trends or patterns were observed in clinical trials.

Taoiseach Micheál Martin on Sunday played down expectations he would request coronavirus vaccine doses from US president Joe Biden during his first bilateral meeting with him on St Patrick's Day.

Speaking on CBS News on Sunday, Mr Martin said he was not aware of “too many countries that are giving their vaccines away”.

Pat Leahy

Pat Leahy

Pat Leahy is Political Editor of The Irish Times

Paul Cullen

Paul Cullen

Paul Cullen is Health Editor of The Irish Times

Simon Carswell

Simon Carswell

Simon Carswell is News Editor of The Irish Times

Suzanne Lynch

Suzanne Lynch

Suzanne Lynch, a former Irish Times journalist, was Washington correspondent and, before that, Europe correspondent