Coronavirus Europe Health

Netherlands suspends use of AstraZeneca vaccine

The Netherlands has joined Ireland in suspending use of the Oxford/AstraZeneca coronavirus vaccine as a precautionary measure following further reports of blood clots in people who have received it, this time from Norway.

Announcing the move late on Sunday, the Dutch health ministry said there was no proof yet of a direct link between the vaccine and reports of possible side-effects from Norway and Denmark and it had not recorded any cases in the Netherlands.

The government said it would now wait for an investigation by the European Medicines Agency (EMA). “We can’t allow any doubts about the vaccine,” Dutch health minister Hugo de Jonge said. “We have to make sure everything is right, so it is wise to pause for now.”

Earlier that day, Ireland’s deputy chief medical officer, Dr Ronan Glynn, said the country’s advisory body on vaccines had recommended that deployment of the AstraZeneca jab should be “temporarily deferred” with immediate effect. He stressed, though, that there was no proof that the vaccine had caused blood clots.

The pause in Ireland’s use of the AstraZeneca vaccine came as the head of the UK’s Office for National Statistics, Prof Sir Ian Diamond, said he had “no doubt” there would be a further wave of coronavirus infections in the autumn.

His comments on BBC One’s Andrew Marr Show echoed warnings from England’s chief medical officer, Prof Chris Whitty, who has said there are risks in reopening society and that the UK will experience another surge of cases at some point, potentially in late summer or through the autumn and winter.

Diamond said the vaccine rollout had been “wonderful”. “But having said that, we need also to recognise that this is a virus that isn’t going to go away. And I have no doubt that in the autumn there will be a further wave of infections.”null

The first reports of blood clots in people receiving the AstraZeneca vaccine came out of Austria and caused a flurry of concern, leading to a number of European countries, including Denmark, pausing their use of it pending investigations. The northern Italian region of Piedmont suspended its use of the vaccine as an “extreme precautionary measure” on Sunday to investigate if there was a causal to the death of a teacher who had received it the day before.

Ireland cited a report into a death and three hospitalisations in Norway that came out on Saturday.

Prof Karina Butler, the head of Ireland’s National Immunisation Advisory Committee (NIAC), said it was acting out of an abundance of caution but wanted to know more about the unexpected cluster of “very serious” clotting events in younger people; Norway said this happened in people under 50. In three cases, it had involved clotting in the brain. In one of them, it was fatal.

There were similarities to other cases reported elsewhere in Europe, she said. It was necessary to know “was there a possibility of a relationship with the vaccine, something which was rare but very serious and could have significant outcomes”, she told Virgin Media News.

The agency did not yet know whether more blood clots were happening than expected in the population generally. “But they do seem to have clustered together at a level and in younger people – I mean less than 65 – where we wouldn’t necessarily have expected them to happen and thus the question was should we just pause until we get that information, because above all we want to maintain confidence in the vaccine programme so that people can feel that what they are getting is safe, that any serious safety signal is being thoroughly investigated,” she said.

There were similarities to other cases reported elsewhere in Europe, she said. It was necessary to know “was there a possibility of a relationship with the vaccine, something which was rare but very serious and could have significant outcomes”, she told Virgin Media News.

The agency did not yet know whether more blood clots were happening than expected in the population generally. “But they do seem to have clustered together at a level and in younger people – I mean less than 65 – where we wouldn’t necessarily have expected them to happen and thus the question was should we just pause until we get that information, because above all we want to maintain confidence in the vaccine programme so that people can feel that what they are getting is safe, that any serious safety signal is being thoroughly investigated,” she said.

In a statement, Glynn said: “It has not been concluded that there is any link between the Covid-19 vaccine AstraZeneca and these cases. However, acting on the precautionary principle, and pending receipt of further information, the NIAC has recommended the temporary deferral of the Covid-19 vaccine AstraZeneca vaccination programme in Ireland.”

Millions of people have had the AstraZeneca jab without any significant side-effects, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has said. Very rare events cannot be detected in clinical trials, however, which involve tens of thousands of people. 

The Norwegian Medicines Agency said the four people under 50 who had the AstraZeneca jab all had a reduced number of blood platelets. It added: “People under the age of 50 who have received the AstraZeneca vaccine and feel increasingly unwell more than three days after vaccination, and who notice larger or smaller blue spots in the skin (skin haemorrhages) must consult a doctor or out-of-hours medical service as soon as possible.

“Similar incidents have been reported in other European countries, and the European Medicines Agency (EMA) is considering whether there may be an association with the coronavirus vaccines. So far, no conclusion has been reached.”

The MHRA said there was no reason to pause use of the vaccine in the UK. “We are aware of the action in Ireland. We are closely reviewing reports but given the large number of doses administered, and the frequency at which blood clots can occur naturally, the evidence available does not suggest the vaccine is the cause,” it said.

AstraZeneca vaccinations make up almost 20% of the 570,000 shots administered in Ireland, mainly to healthcare workers after its use was not initially recommended for those over 70.

A spokesperson for the company said there had been no signal from clinical trials or its safety data covering more than 17m doses of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia. In fact, the reported numbers of these types of events for AstraZeneca jab recipients were lower than the number that would have occurred naturally in the unvaccinated population, he said.

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