In March, more than a dozen countries, including Germany, suspended using AstraZeneca over the blood clot issue. Most EU nations restarted on March 19 some with age restrictions after the EMA said the benefits of the vaccine outweighed the risks of not inoculating people against COVID-19. At the time, the EMA recommended the vaccines leaflet be updated with information about the rare clots.
Any further doubts about the AstraZeneca vaccine would be a setback for the shot, which is critical to Europes immunisation campaign and a linchpin in the global strategy to get vaccines to poorer countries. The AstraZeneca vaccine is cheaper and easier to use than rival vaccines from Pfizer and Moderna and has been endorsed for use in more than 50 countries, including by the 27-nation EU and the WHO. US authorities are still evaluating the vaccine.
Cavaleri said while EMA was prepared to declare a link, further study was still needed to understand why and how the phenomenon occurs.
He said the rare blood clots, including some in the brain, coupled with a low level of blood platelets that may make people at risk of serious bleeding, seem to be the key event to study further. Cavaleri promised more details soon, adding: In the coming hours, we will say that the link is there, how this happens we still havent figured out.
Cavaleri said the biological mechanism for how the vaccine might be causing the rare clots was still unknown and if it was linked to how the shot was made, other vaccines with similar technologies might also need to be evaluated.
He stressed the risk-benefit analysis remained positive for the AstraZeneca jab, even for young women who appear to be more affected by the clots.
Lets not forget that young women also end up in intensive care with COVID. So we need to do very meticulous work to understand if the risk-benefit analysis remains for all ages, he was quoted as saying.
He ruled out a preventive therapy to address the rare blood clots, saying there was still too much unknown about the phenomenon.
Even after the March 19 restart, the Dutch and German governments suspended the jabs for people under 60 and some Europeans have been shying away from getting a shot.
Romanias national vaccination committees chief, Valeriu Gheorghita, said on Tuesday that since March, 207,000 people in Romania had cancelled their AstraZeneca vaccine appointments and another 92,000 simply didnt show up.
It is a high percentage, a third of people scheduled who did not show up, Gheorghita told reporters.
British Prime Minister Boris Johnson declined to be drawn directly into the latest warnings about the vaccine but urged people to look at the advice from Britains independent Medicines and Healthcare Regulatory Agency.
Their advice to people is to keep going out there, get your jab, get your second jab, he said during a visit to an AstraZeneca facility in Macclesfield, in north-west England.
Last week, Britains MHRA said seven people had died in the UK due to blood clots after getting the AstraZeneca jab. It said it wasnt clear if the shots were causing the clot and that it was undertaking a rigorous review into the reports. The agency said it had identified 30 blood clot cases out of 18.1 million AstraZeneca jabs given by March 24.
Adam Finn, a professor of paediatrics at the University of Bristol, said the latest surge of COVID-19 cases that is filling up hospitals across Europe should prompt people to get vaccinated as soon as possible.
If you are currently being offered a dose of Oxford-AstraZeneca vaccine, your chances of remaining alive and well will go up if you take the vaccine and will go down if you dont, he said.