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The EU medicines regulator said it remains “firmly convinced” that the benefits of the Oxford / AstraZeneca Covid vaccine outweigh the risks, but isolated cases of blood clots “are of serious concern and require evaluation serious and detailed scientific ”.
Emer Cooke, the head of the European Medicines Agency (EMA), said there was no indication that the gunshot caused any of the incidents, but the agency was investigating them thoroughly and would make its findings Thursday.
Sweden and Latvia on Tuesday followed more than a dozen European countries, including Germany, France, Italy and Spain, to temporarily halt vaccinations against AstraZeneca following isolated cases of bleeding, blood clots and low platelet counts.
While the number of incidents in those vaccinated “does not appear to be greater than that observed in the general population,” Cooke suggested that the risks may be higher for certain categories of patients.
“What we understand is that they can be associated with certain subpopulations,” she said. Some experts have also said that rare cases of very unusual cerebral thrombosis in younger people could indicate a causal link with the shooting.
Karl Lauterbach, professor of epidemiology and German MP, told German radio that “the risks of the vaccine may be higher for certain groups, such as young women. The EMA may issue specific warnings. “
Germany’s health ministry said on Tuesday it had a “legal obligation” to suspend vaccination after receiving three more reports of rare cerebral thrombosis, cerebral sinus vein thrombosis, or CSVT, since Friday. Three of the seven patients with CSVT have since died, he said.
Statistically, the ministry said, the incidence rate of CSVT among AstraZeneca beneficiaries appeared to be three or four times higher than one would normally expect, at around four per million instead of 1-1. , 4 per million.
Young people, especially young women, also appeared to be over-represented in CVST cases, the ministry said, adding that while it was legitimate to continue to vaccinate during its investigation, it had a duty of care to individual beneficiaries.
Cooke declined to comment on the national decisions, saying they were taken “in the context of national level information.” She said it was the EMA’s responsibility to “look at the science and see if these risks are causally linked” to the vaccine.
The World Health Organization, which on Monday urged countries to continue using the AstraZeneca vaccine while the investigation was ongoing, said its expert group on safety is also meeting and is expected to issue a statement. Tuesday.
French Health Minister Olivier Véran said earlier on Tuesday that he hoped the break would not last long. “We expect some sort of verdict from the European scientific community by Thursday afternoon, allowing us to resume the campaign,” he said.
The head of the vaccination program in France, Alain Fischer, also said he expected the break to be short but added that it was “reasonable” given “the incidents which are more significant by their atypical character. than by their number ”.
The fact that there have been “a few very unusual and disturbing cases justifies this pause and analysis,” Fischer said. “It’s not wasted time,” he said of the suspension. “It takes time to do an analysis.”
Klaus Cichutek, head of the German regulator, the Paul Ehrlich Institute, said he had discovered “cases of sinus vein thrombosis in women aged around 20 to 50, two of whom were tragically fatal.”
German Health Minister Jens Spahn said on Monday the decision to suspend shooting was based on expert advice. Out of 1.6 million people in Germany who received the AstraZeneca vaccine, seven became ill and three died, he said.
Denmark and Norway last week reported incidents of bleeding, blood clots and low blood platelet counts in several people who received the AstraZeneca vaccine, both describing the symptoms as “very unusual”.
A 60-year-old Danish recipient has since died of a blood clot, while two health workers in Norway, both under the age of 50 and described as previously fit and healthy, have died from brain hemorrhages. Italy has recorded eight deaths and four cases of serious side effects after vaccination.
European governments have said they have acted very cautiously, but also fear their decisions will deprive them of essential doses to step up vaccination campaigns which have been hampered by scarcity of supplies.
In major EU Member States such as Germany, France, Italy, the Netherlands and Spain, AstraZeneca has accounted for 13-15% of administered shots since the launch of the deployment there is nearly three months old, Pfizer-BioNTech constituting the majority.
Epidemiologists across the continent have said clear guidelines are urgently needed because of the importance of the global immunization campaign to curb the spread of the pandemic.
“In at-risk groups, the risk of dying from Covid is much, much higher,” said Dirk Brockmann of the German Robert Koch Institute for Infectious Diseases. “This means that a person is probably 100,000 times more likely to die from Covid than from an AstraZeneca vaccine.”
AstraZeneca said last week it would try to deliver 30 million doses to the European Union by the end of March, only a third of its 90 million contractual obligation and a further reduction in its February pledge to deliver 40 million doses.
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