No evidence of causal link between AstraZeneca shot and health incidents – WHO

Advisory panel reviewing vaccine reports as several countries temporarily suspend its use

A nurse holds a vial of the Oxford-AstraZeneca vaccine against the coronavirus disease at an infectious diseases hospital in Tbilisi. Photograph:  Vano Shlamov/ AFP via Getty
A nurse holds a vial of the Oxford-AstraZeneca vaccine against the coronavirus disease at an infectious diseases hospital in Tbilisi. Photograph: Vano Shlamov/ AFP via Getty

The World Health Organisation (WHO) said on Monday that its advisory panel was reviewing reports related to AstraZeneca's Covid-19 vaccine but there was no evidence that any health incidents were caused by the shot.

In a reply to Reuters, WHO spokesman Christian Lindmeier said: “As soon as WHO has gained a full understanding of these events, the findings and any unlikely changes to current recommendations will be immediately communicated to the public.

“As of today, there is no evidence that the incidents are caused by the vaccine and it is important that vaccination campaigns continue so that we can save lives and stem severe disease from the virus,” he added.

The statement comes after the head of the Oxford University vaccine group sought to reassure the public over its Covid-19 jab after several countries temporarily suspended its use.

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Professor Andrew Pollard said that while it was right that regulators investigated reports of blood clots in people who have had the vaccine, data from millions of people was "very reassuring" that there was no link.

Germany became the latest country to suspend use of the Oxford/AstraZeneca vaccine over concerns about possible side-effects.

The German health ministry said the new guidelines implemented a recommendation from the Paul Ehrlich Institute, Germany’s authority in charge of vaccines.

The Netherlands also moved to suspend use of the vaccine with the Dutch government saying the precautionary move will last until at least March 29th, following a similar decision made by Ireland.

Ireland's National Immunisation Advisory Committee (Niac) recommended that the administration of the AstraZeneca Covid-19 vaccine be temporarily deferred from Sunday morning.

Deputy chief medical officer Ronan Glynn said the recommendation was 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"

Denmark, Norway, Bulgaria, Iceland and all temporarily suspended their use of the AstraZeneca jab.

Last week, the WHO, the European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said there was no evidence of a link between the jab and an increased risk of blood clots.

Prof Pollard said “safety is clearly absolutely paramount” but that about 3,000 cases of blood clots occur every month in the UK from other causes.

“So, when you then put a vaccination campaign on top of that, clearly those blood clots still happen and you’ve got to then try and separate out whether, when they occur, they are at all related to the vaccine or not,” he told BBC Radio 4’s Today programme.

Prof Pollard said that more than 11 million doses have now been given in the UK, and the MHRA has said “very clearly that they’re not seeing any increase in the number of cases of blood clots” over what they would see normally.

“I think at this moment we’ve got the most data from the UK, which looks very reassuring, but of course it’s absolutely right that there’s careful monitoring of safety and this gets looked into,” he said.

‘Huge risks’

The professor pointed to the “huge risks” from Covid-19 for those who are unvaccinated, adding that “if we have no vaccination and we come out of lockdown in this country, we will expect tens of thousands of more deaths to occur during this year”.

He continued: "A number of countries around Europe are now seeing an increase in cases again.

"Italy and France and Germany and Poland — all have the start of a new surge in cases.

“It’s absolutely critical that we don’t have a problem of not vaccinating people and have the balance of a huge risk — a known risk of Covid — against what appears so far from the data that we’ve got from the regulators — no signal of a problem.”

Elsewhere, Professor Anthony Harnden, deputy chairman of the Joint Committee on Vaccination and Immunisation (JCVI), also sought to reassure the public and said people should attend their vaccine appointments.

He said that the EMA, the MHRA, the World Health Organisation and AstraZeneca have “all said this vaccine is safe”.

He told BBC Breakfast: “The data that we look at on a weekly basis on JCVI and a daily basis at MHRA are reassuring that there is no link, so we are right in this country to press on.

“We will keep monitoring this and if there is any safety signals that we are concerned about, we would let the public know straight away.

“At the moment, the message is absolutely clear — go and get your vaccine when offered.

Prof Harnden said analysis of the 11 million doses of the vaccine given so far in the UK had found “no demonstrable difference between the blood clots in those that have been vaccinated from those in the general population”.

Prof Harnden said all over-50s in the UK can expect to be vaccinated in the next few weeks. “Most people over the age of 50 will be vaccinated really within the next few weeks — so it is tremendously successful,” he said of the vaccination programme.

On the issue of side-effects, Prof Harnden said women were more likely to get them from the Oxford/AstraZeneca jab than were men.

“The Oxford/AstraZeneca vaccine — for the first dose — seems to give quite a lot of minor side effects like: a very sore arm; fever; malaise; headache and sometimes chills which may last for up to 48 hours afterwards,” he said.

"With the Pfizer vaccine, which we are given at the moment, it seems to be the reverse — side-effects are more likely with the second vaccine."

AstraZeneca said its own review had found no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country.

In clinical trials for the jab, the number of clotting incidents was small and “lower in the vaccinated group” than in those who were unvaccinated, it added.

Germany and Italy

On Monday afternoon, Germany said it will stop administering AstraZeneca’s Covid-19 vaccine, a spokesman for the health ministry said on Monday, making Germany the latest of several European countries to pause following reports of recipients being taken ill.

The ministry said the new guidelines implemented a recommendation from the Paul Ehrlich Institute, Germany’s authority in charge of vaccines.

Meanwhille, prosecutors in Italy seized a batch of 393,600 shots of the AstraZeneca vaccine following the death of a man hours after he had received a jab in the northern region of Piedmont .

The move represents another blow to the image of the AstraZeneca vaccine in Italy and will further hinder the government’s anti-coronavirus inoculation campaign.

On Sunday Piedmont’s regional government suspended use of the batch, ABV5811, after Sandro Tognatti, a 57-year-old music teacher, fell ill and died in circumstances that have not yet been clarified.

Magistrates in Sicily ordered the seizure of a separate batch of AstraZeneca vaccine last week following the sudden deaths of two men who had recently been inoculated.

The Italian government has said there was no evidence of a connection between the deaths and the jabs and has allowed the AstraZeneca vaccine to continue to be administered.

By contrast, Ireland, Denmark, Norway and Iceland have all suspended use of the vaccine following blot-clotting issues, some of them fatal, in people who had used it.

Mr Tognatti had his shot on Saturday afternoon, his wife told Italian newspapers. He developed a high temperature during the night and felt ill again on Sunday morning. An ambulance was called, but he died shortly afterwards.

“It is therefore important to ensure that continued administration of the drug throughout the country does not lead to further consequences (harmful or fatal) ... until we are completely sure that (Tognatti’s) death cannot be attributed to the above-mentioned inoculation,” prosecutor Teresa Angela Camelio said in a statement. –Agencies