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The investigation by European experts into suspected links between the offending vaccine and blood clots did not find any specific risk factors, the European Medicines Agency announced on Wednesday.
No proven risk of thrombosis linked to the AstraZeneca vaccine. Experts investigating suspected links between the offending vaccine and blood clots have not found any specific risk factors, including age, the European Medicines Agency (EMA) said on Wednesday (March 31st).
The European regulator, which is continuing its analyzes, however specified that its safety committee should publish “updated recommendations” on the controversial vaccine after its monthly meeting, scheduled for next week.
“No causal link”
Germany, like a number of other countries, on Tuesday advised against using the product for younger people, reserving it for those over 60, after reports of a few cases of blood clot problems. And this despite the assurances of the EMA, which had judged mid-March the vaccine “safe and effective”, considering that it was “not associated” with a higher risk of thrombosis.
“For the moment, the examinations have not identified any specific risk factors such as age, gender or a medical history including problems with blood clots for these very rare cases” reported of complications occurring in people vaccinated with AstraZeneca, EMA said in a statement Wednesday.
“No causal link to the vaccine is proven. But it is possible, and further analysis is underway,” EMA Executive Director Emer Cooke said on a video conference.
“Based on current scientific knowledge, there is no evidence to support the restriction of the use of the vaccine for part of the population,” she said.
The European drug gendarme has identified 62 cases of cerebral venous thrombosis worldwide, including 44 in the 30 countries of the European Economic Area (EU, Iceland, Norway, Liechtenstein) for 9.2 million doses of vaccine administered in this zoned.
Fourteen deaths have been recorded, without always being able to be reliably attributable to the thrombosis, added Emer Cooke.
However, the agency clarified that these data, fragmentary, did not include statistics from Brazil – a large user of the AstraZeneca vaccine behind the United Kingdom and India – and that they ended on March 22, without including most recent cases reported in Germany.
Regarding the restriction decided by the German government, the EMA referred to the authorities in that country, who “are looking at this issue based on the vaccines they have at their disposal and the risks to the German population. is not in itself a regulator’s decision on the product, ”Emer Cooke said.
“It is very complicated to make general decisions on the risk-benefit balance, because it depends on the Covid incidence rate that a population is facing, depending on whether you are a medical worker, a teacher … Different factors play” , she explained.
The EMA was speaking after an expert meeting on Monday to present their latest assessments of the AstraZeneca vaccine. Their comments will be considered next week at the agency’s security committee meeting.
The European regulator reiterated its opinion already formulated on March 18: “Its benefits in protecting people from Covid-19, with the associated risks of death and hospitalization, outweigh the possible risks”.
Contrary to EU countries, Norway decided on Friday to extend the suspension of the AstraZeneca vaccine until April 15, its health authorities deeming it necessary to deepen their examination and saying “suspect” a causal link with “these effects very serious secondary “.