The EU’s medicines regulator has said it remains “firmly convinced” the benefits of the Oxford/AstraZeneca Covid vaccine outweigh the risks, but isolated cases of blood clots “are a serious concern and need serious and detailed scientific evaluation”.
Emer Cooke, the head of the European Medicines Agency (EMA), said there was no indication the shot had caused any of the incidents, but the agency was investigating them thoroughly and would report its conclusions on Thursday.
The Italian prime minister, Mario Draghi, said on Tuesday he had spoken to the French president, Emmanuel Macron, and the two had agreed to resume vaccinations “quickly” if the EMA gave a green light. He described the preliminary statement from the regulator as “positive”.
Sweden and Latvia on Tuesday followed more than a dozen European countries, including Germany, France, Italy and Spain, in temporarily halting AstraZeneca vaccinations following isolated cases of bleeding, blood clots and low platelet counts.
While the number of incidents in vaccinated people “does not seem to be any higher than that seen in the general population”, Cooke suggested it was possible that the risks may be higher for some patient categories.
“What we’re understanding is that they may be associated with some sub-populations,” she said. Some experts have also said rare cases of highly unusual cerebral thrombosis in younger people could possible indicate a causal link to the shot.
Karl Lauterbach, a professor of epidemiology and a German MP, told German radio it “could be the case that the risks of the vaccine are higher for certain groups, such as young women. It is possible that the EMA will issue specific warnings.”
'no indication' Oxford vaccine is linked to blood clots, says EU regulator
Germany’s health ministry on Tuesday said it had a “legal obligation” to suspend vaccination after receiving three more reports of a rare cerebral thrombosis, cerebral sinus venous thrombosis or CSVT, since Friday. Three of seven CSVT patients have since died, it said.
Statistically, the ministry said, the incidence rate of CSVT in AstraZeneca recipients appeared to be three or four times higher that would normally be expected, at about four per million rather than 1-1.4 per million.
Young people, especially young women, also seemed over-represented in the CVST cases, the ministry said, adding that while there was a legitimate case for carrying on vaccinating while it investigated, it had a duty of care to individual recipients.
Cooke declined to comment on national decisions, saying they were made “in the context of information at national level”. She said it was the EMA’s responsibility to “look at the science and see if these risks are causally related” to the vaccine.
The World Health Organization, which on Monday urged countries to continue using the AstraZeneca vaccine while the investigation was under way, said its expert safety panel was also meeting and expected to publish a statement on Tuesday.
The French health minister, Olivier Véran, said earlier on Tuesday he hoped the pause would not last long. “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 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. Italy has recorded eight deaths and four cases of serious side-effects after vaccination.
European governments have said they acted out of an abundance of caution, but are also concerned that their decisions will deprive them of much-needed doses to step up vaccination campaigns that have been dogged by scarce supplies.
In major EU member states such as Germany, France, Italy, the Netherlands and Spain, AstraZeneca has accounted for 13-15% of shots administered since the rollout started almost three months ago, with Pfizer-BioNTech making up the majority.
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.”
AstraZeneca said last week it would try to deliver 30m doses to the European Union by the end of March, only a third of its contractual obligation of 90m and a further reduction on its February promise to deliver 40m doses.(The Guardian)