A UK trial of the AstraZeneca coronavirus vaccine in children has been suspended, the University of Oxford said on Tuesday, as global regulators rush to assess its possible link to rare blood clots in adults.
The university, which helped develop the besieged vaccine, said in a statement that there were “no safety concerns” with the trial, but acknowledged fears about a potential link to clots in saying she was awaiting further data from the UK Medicines and Health Products Regulation. (MHRA) before restarting the study.
“Parents and children should continue to attend all scheduled tours and can contact trial sites if they have any questions,” he added.
It’s the latest drama to hit AstraZeneca, which has been embroiled in controversy over its inability to deliver promised doses to the European Union, and the jab’s efficacy and safety profile.
The MHRA is one of many organizations around the world analyzing real-world data from the AstraZeneca deployment to see if there is a definitive link between jab and a rare form of blood clot, after cases have been reported. initially reported in Norway and mainland Europe.
The MHRA reported over the weekend that there had been 30 cases of blood clotting, seven fatalities, out of the 18 million doses administered in Britain.
The European Medicines Agency said on Tuesday it “has not yet come to a conclusion and the review is currently underway.”
EU Health Commissioner Stella Kyriakides later said the agency was due to make its decision “Wednesday evening”, adding that she was in “close contact” with the EMA.
The statement came after EMA’s vaccine strategy manager Marco Cavaleri was quoted in Italian media as saying there was a “clear” link and the agency would announce it within hours .
“In my opinion, we can say it now, it is clear that there is a link with the vaccine,” Cavaleri told Italian newspaper Il Messaggero in an interview. “But we still don’t know what is causing this reaction.”
Germany and France have both restricted the use of the vaccine to older people over concerns that younger recipients are potentially at higher risk of clots.
Britain and the developers of the vaccine had so far resisted any restrictions on use, saying there was no evidence of a link.
Adam Finn, professor of pediatrics at the UK University of Bristol, said the benefits continued to outweigh the risks.
“We need to know more about those affected and we need to understand exactly how the diseases came about,” he said.
“If you are currently offered a dose of the Oxford-AstraZeneca vaccine, your chances of staying alive and well will increase if you take the vaccine and decrease if you don’t,” he added.