France has said it hopes Europe’s medicines regulator will clear up concerns over the safety of the Oxford/AstraZeneca Covid-19 shot by Thursday, as Sweden became the latest European country to suspend use of the shot.
Germany, France, Italy and Spain followed several other EU countries on Monday in pausing AstraZeneca vaccinations pending investigation by the European Medicines Agency (EMA) into isolated cases of bleeding, blood clots and low platelet counts.
On Tuesday Sweden and Latvia followed, bringing the number of European countries temporarily halting the shot to more than a dozen. The World Health Organization (WHO) and the EMA have said there is no proven link between the clots and the jab.
The EMA was meeting on Tuesday and was expected to make a statement afterwards, a European commission spokesman said, while the WHO said its expert panel was also reviewing the evidence and might issue a statement on Tuesday.
Sweden’s state epidemiologist, Anders Tegnell, whose light-touch approach to controlling the pandemic has been an international outlier, said 10-20 cases in Europe of post-vaccination haemorrhages needed further investigation.
The French health minister, Olivier Véran, said the benefits of the shot far outweighed the risks. “We expect some kind of verdict from the European scientific community by Thursday afternoon, allowing us to resume the campaign,” he said.
The head of France’s vaccination programme, Alain Fischer, also said he expected the pause to be short-lived but added that it was “reasonable” given “incidents that are significant more by their atypical nature than by their number”.
The fact that there were “a few very unusual and troubling cases justify this pause and the analysis”, Fischer said. “It’s not lost time,” he said of the suspension. “It’s necessary time to carry out analysis.”
Klaus Cichutek, the head of Germany’s regulator, the Paul Ehrlich Institute, said it had uncovered “cases of sinus vein thrombosis in women between the ages of around 20 and 50 years, two of which tragically had a fatal outcome”.
The German health minister, Jens Spahn, said on Monday the decision to suspend the shot was based on expert advice. Out of 1.6 million people in Germany who had received the AstraZeneca vaccine, seven had fallen ill and three died, he said.
Denmark and Norway last week reported incidents of bleeding, blood clots and a low count of blood platelets in several people who had received the AstraZeneca shot, both describing the symptoms as “highly unusual”.
A 60-year-old Danish recipient has since died from a blood clot, while two health workers in Norway, both aged under 50 and described as previously fit and healthy, have died of brain haemorrhages.
In Italy, where there have been eight deaths and four cases of serious side-effects after vaccination, the director general of the national medicines authority, Aifa, told la Repubblica that the decision to suspend inoculation was “a political one”.
Epidemiologists across the continent said clear guidance was urgently needed because of the importance of the global immunisation campaign in curbing the spread of the pandemic.
“In the risk groups the risk of dying of Covid is much, much higher,” said Dirk Brockmann of Germany’s Robert Koch Institute for infectious diseases. “That means one is probably 100,000 times more likely to die of Covid than because of an AstraZeneca vaccine.”
The WHO’s chief scientist, Soumya Swaminathan, said on Monday it “would, for the time being, recommend that countries continue vaccinating with AstraZeneca. So far, we do not find an association between these events and the vaccine.”
The EMA said on Monday that “many thousands of people develop blood clots annually in the EU for different reasons” and the number of incidents in vaccinated people “seems not to be higher than that seen in the general population”.
It also said: “The benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risks of side-effects.”