The EU’s three largest countries have suspended the Oxford/AstraZeneca’s Covid vaccine, hours after the World Health Organization said it had seen no evidence the shot had caused blood clots in some people who received it.
The German health ministry said the country’s vaccine authority, the Paul Ehrlich Institute, “considers further investigation necessary after new reports of cerebral brain thrombosis in connection with vaccination in Germany and Europe”.
The European Medicines Agency (EMA) should decide “whether and how the new findings will affect the approval of the vaccine”, the ministry said. The health minister, Jens Spahn, said seven cases of cerebral vein thrombosis had been reported.
While this was a “very low risk” compared with the 1.6 million jabs already given in the country, Spahn said, it would be above average if a link to the vaccine was confirmed. “The decision today is a purely precautionary measure,” he said.
The French president, Emmanuel Macron, said France would also stop administering the AstraZeneca shot “out of precaution … in the hope we can resume quickly if the EMA gives the green light” at a meeting scheduled for Tuesday afternoon.
Joining a growing number of European countries to temporarily halt the use of the vaccine in recent days, Italy’s medicines authority, Aifa, said it was also suspending inoculations as a “precautionary and temporary measure” before the EMA decision.
Denmark and Norway last week reported incidents of bleeding, blood clots and a low count of blood platelets in people who had received the AstraZeneca shot, prompting Ireland and the Netherlands to join them on Sunday in temporary suspensions.
Karl Lauterbach, a professor of health economic and epidemiology at the University of Cologne and a German MP, criticised Germany’s decision. “Based on the data available, I consider this to be a mistake,” Lauterbach said.
“Testing without suspension of vaccination would have been better because of the rarity of the complication. In the third wave, which is now picking up speed, the first vaccinations with the AstraZeneca vaccine would be lifesavers.”
A WHO spokesperson, Christian Lindmeier, earlier on Monday said it would communicate its findings and “any unlikely changes to current recommendations” as soon as it had investigated the incidents.
However, “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”, Lindmeier said.
The Netherlands clarified on Monday that it had recorded 10 cases of “noteworthy adverse side-effects” from the AstraZeneca vaccine, while Denmark said “highly unusual” symptoms were seen in a 60-year-old recipient who died from a blood clot.
The agency said in a statement that the woman had “a low number of blood platelets and clots in small and large vessels, as well as bleeding”. Norway also spoke of “unusual symptoms” in three people under 50 being treated in hospital.
Austria stopped using one batch of the AstraZeneca vaccine on 8 March after a 49-year-old nurse died from “severe bleeding disorders”, and prosecutors in the northern Italian region of Piedmont on Monday seized a batch of 393,600 doses after a 57-year-old music teacher fell ill and died.
AstraZeneca said 17 million people had so far received the jab and the 15 incidences of deep vein thrombosis (DVT) and 22 events of pulmonary embolism recorded were “much lower than would be expected to occur naturally in a general population”.
Andrew Pollard, the director of the Oxford Vaccine Group which developed the vaccine with the firm, told the BBC there was “very reassuring evidence that there is no increase in a blood clot phenomenon here in the UK, where most of the doses in Europe have been given so far”.
Downing Street also said the vaccine “remains both safe and effective”. Boris Johnson’s official spokesman said there was “no evidence” that blood clots are any more likely to occur following vaccination.
Adding to the pharmaceutical firm’s problems, AstraZeneca said at the weekend it would not be able to meet its delivery targets to the EU in the first quarter and could have problems in the second quarter too.
The company’s initial target was for 120m doses in the first quarter of the year and 180m in the second. It then lowered its first-quarter target to 40m, citing “lower-than-expected output from the production process”, but is now looking at just 30m.
Although it still aims to supply 100m in the second quarter, leaked documents suggest that figure may now be only 70m – meaning the company would have supplied 100m of the 300m doses it promised the EU in the first half.
AstraZeneca said on Saturday it hoped it would be able to compensate production difficulties in its European plants with supplies from its global network which were being stymied by some countries’ export restrictions.
The US is refusing to release 30m unused doses even though the vaccine has not been approved by US regulators, while the head of Sweden’s vaccination programme said at the weekend there were clear “contractual obstacles” to AstraZeneca exporting supplies to the EU from the UK.