There is no evidence to suggest the Oxford/AstraZeneca vaccine causes blood clots, the UK’s medicines regulator has said, after a number of European countries temporarily suspended its use.
The Covid vaccine’s manufacturer has also insisted it is safe, saying a review of available data in more than 17m people who have been vaccinated across the UK and EU has shown no evidence of an increased risk.
After Ireland announced on Sunday that it was suspending use of the jabs as a “precautionary step”, the UK’s medicines regulator said the available evidence “does not suggest the vaccine is the cause” of clots.
And on Monday afternoon, France, Italy and Germany announced they were suspending the use of the vaccine. Europe’s medicines regulator, the European Medicines Agency (EMA), will hold an emergency meeting on Thursday to consider its next move but insisted the vaccine’s benefits continue to outweigh its risks and that jabs can keep being administered.
Dr Phil Bryan, vaccines safety lead at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), said people “should still go and get their Covid-19 vaccine when asked to do so”.
Despite the Republic’s move, Northern Ireland’s department of health said the rollout there would continue “in line with MHRA guidance”.
Irish health minister Stephen Donnelly said use of the Oxford/AstraZeneca jab there had been temporarily suspended “based on new information from Norway”.
The decision followed reports of serious clotting in adults in Norway which left four people in hospital.
The Netherlands also said on Sunday that it was suspending use of the vaccinations as a precaution for two weeks.
Professor Andrew Pollard, director of the Oxford vaccine group, which developed the Oxford/AstraZeneca jab, said “safety is clearly absolutely paramount” but no link had been found between the vaccine and blood clots.
He told BBC Radio 4’s Today programme it was “important to understand that a lot of stuff happens to people all the time in normal times and, in the case of blood clots here in the UK, we see about 3,000 cases of blood clots happening every month”.
“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 said more than 11m doses had now been given in the UK and the MHRA had said “very clearly that they’re not seeing any increase in the number of cases of blood clots” over what they would see normally.
Finland has also done a “very careful study” and have not found an increased risk, he added.
“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.”
Professor Sir David Spiegelhalter backed up AstraZeneca’s claim there was no evidence that the Oxford jab increased risk of deep vein thrombosis (DVT) in any defined age group, gender, batch or in any particular country.
“I’ve looked at the AstraZeneca reports and they’ve said that 17m jabs across the EU and the UK [had been administered] and they’ve had about 15 cases of deep vein thrombosis and 22 cases of pulmonary embolism reported,” he told Radio 4′s World At One.
“Doing some some sums, deep vein thrombosis happens to one in 1,000 people per year of all ages.
“So, out of those 17m jabs, we would expect at least 17,000 of those people to get a deep vein thrombosis some time in the year. So that means that there will have been – and you can pretty well guarantee it – 350 people who have had an AstraZeneca jab then had a deep vein thrombosis in the week following that.
“I think what’s surprising is that only 15 have been reported as a possible adverse effect.”
While several European countries have already temporarily suspended use of the jabs, the EMA noted last week that there had only been 30 cases reported among almost five million people jabbed in the European Economic Area.
It said in a statement: “While its investigation is ongoing, EMA currently remains of the view that the benefits of the AstraZeneca vaccine in preventing Covid-19 with its associated risk of hospitalisation and death, outweigh the risks of side effects.”
The number of cases of blood clots reported is lower than the hundreds of cases that would be expected among the general population, AstraZeneca’s chief medical officer Ann Taylor said.
The pharmaceutical giant said its 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.
Dr Taylor said: “Around 17m people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population.
“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety.”
Dr Bryan said: “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.
“People should still go and get their Covid-19 vaccine when asked to do so.”