A UK trial of the AstraZeneca coronavirus vaccine against children has been suspended, Oxford University said on Tuesday, as global regulators rushed to assess its possible link to rare blood clots in adults.
The university, which helped develop the vaccine involved, said in a statement that there were “no safety concerns” in the trial, but acknowledged concerns about a potential link to blood clots, saying it was awaiting further information from Britain’s drug and healthcare products . Agency (MHRA) before restarting the study.
“Parents and children should continue to attend all scheduled visits and can contact the test sites if they have any questions,” it added.
It is the latest drama to hit AstraZeneca, which has been embroiled in controversy over its failure to deliver promised doses to the European Union, and over jab’s efficacy and safety profile.
MHRA is one of many bodies around the world that analyze real data from the AstraZeneca launch to see if there is a definite link between jab and a rare form of blood clot, after cases were originally reported in Norway and continental Europe.
The MHRA reported over the weekend that there had been 30 blood clots, seven fatal, of the 18 million doses administered in the UK.
The European Medicines Agency said on Tuesday that it “has not yet reached a conclusion and the review is currently under way”.
EU Health Commissioner Stella Kyriakides later said the agency was expected to make its decision “late on Wednesday”, adding that she was in “close contact” with the EMA.
The statement came after the EMA’s head of vaccine strategy, Marco Cavaleri, was quoted in Italian media as saying that there was a “clear” link and that the authority would announce it within a few hours.
“In my opinion, we can say it now, it is clear that there is a link to the vaccine,” Cavaleri told Italian newspaper Il Messaggero in an interview. “But we still do not know what is causing this reaction.”
Germany and France have both restricted the use of the vaccine to older people for fear that younger recipients are potentially more prone to blood clots.
The UK and vaccine developers had so far resisted any restrictions on its use, saying there was no evidence of any link.
Adam Finn, professor of pediatrics at the University of Bristol in the UK, said the benefits outweighed the risks.
“We need to know more about those affected and we need to understand exactly how the diseases originated,” he said.
“If you are currently offered a dose of Oxford-AstraZeneca vaccine, your chances of staying alive will increase if you take the vaccine and will decrease if you do not,” he added.