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A senior official from the European Medicines Agency (EMA) has said it is “clear” there is a link between the Oxford/AstraZeneca vaccine and a rare blood clotting syndrome, but that the cause is not yet known.
“In my opinion, we can say it now, it is clear there is a link with the vaccine,” Marco Cavaleri, the European drug regulator’s head of vaccines, told Italy’s Il Messaggero newspaper. “But we still do not know what causes this reaction.”
Cavaleri said the EMA, which has said it would issue an “updated recommendation” on the shot on Wednesday, would officially announce a connection “in the next few hours” although “we still have to understand how this happens”.
The World Health Organization, EMA and Medicines and Healthcare products Regulatory Agency (MHRA) have all said people should continue taking the jab because the benefits in preventing Covid-19 infection and its complications continue to far outweigh any risks.
Concerns over rare but serious blood clotting events in a small number of recipients have dogged the shot in recent weeks, with more than a dozen European countries briefly suspending its use last month pending an EMA investigation.
The regulator subsequently said the vaccine was safe and effective, but added that it could not definitively rule out a connection between the shot and the rare clotting events and so was continuing to investigate.
Most countries have since resumed inoculation with the AstraZeneca shot, but several – including France, Germany, Italy, France, Spain, the Netherlands and Canada – have restricted its administration in people aged under 55 or 60.
The EMA is looking into 14 deaths among recipients of the jab that had been reported by 22 March and are related to unusual blood clots in the brain, known as cerebral venous sinus thrombosis, accompanied by a low platelet count. A high proportion among the reported cases affected were young and middle-aged women.
“We are trying to get a precise picture of what is happening, to define in detail this syndrome due to the vaccine,” Cavaleri told the paper. “Among the vaccinated, there are more cases of cerebral thrombosis … among young people than we would expect.”
The UK regulator, the MHRA, has also reported 22 cases of CSVT as well as eight reports of other blood clotting problems with low platelets, up to and including 24 March. Of these 30 reports, the agency has said seven people had died.
Channel 4 reported on Monday that the MHRA was considering restricting the shot in the under-30s and could make an announcement on Tuesday, although the MHRA’s chief executive, Dr June Raine, said no decision had yet been made.
Prof Neil Ferguson of Imperial College London told the BBC on Monday that the clots raised questions over whether young people should get the jab.
Ferguson said: “There is increasing evidence that there is a rare risk associated particularly with the AstraZeneca vaccine – but it may be associated at a lower level with other vaccines – of these unusual blood clots with low platelet counts.
“It appears that risk is age-related, it may possibly be – but the data is weaker on this – related to sex.” Prof Paul Hunter, a medical microbiologist at the University of East Anglia, told the BBC the “chances of a random association are very, very low”.
Source: The Guardian
Keyword: EMA finds ‘clear’ link between AstraZeneca vaccine and blood clots | Coronavirus