Oxford-AstraZeneca vaccine trial in children paused
Published: 02:45 PM, 7 April 2021
A UK trial of the Oxford-AstraZeneca coronavirus vaccine on children has been paused while regulators assess its possible link to blood clots, the University of Oxford said Tuesday.
“Whilst there are no safety concerns in the paediatric clinical trial, we await additional information from the MHRA (Britain’s Medicines and Healthcare products Regulatory Agency) on its review of rare cases of thrombosis/thrombocytopaenia that have been reported in adults, before giving any further vaccinations in the trial,” the university, which helped develop the embattled vaccine, said in a statement.
“Parents and children should continue to attend all scheduled visits and can contact the trial 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 the jab’s efficacy and safety profile.
The MHRA is one of many bodies across the globe analysing real world data from the AstraZeneca rollout to see if there is a definitive link between the jab and a rare form of blood clot, after cases were initially reported in Norway and continental Europe.
The MHRA reported over the weekend that there had been 30 blood clotting cases, seven fatal, out of the 18 million doses administered in Britain.
The European Medicines Agency (EMA) said Tuesday it “has not yet reached a conclusion and the review is currently ongoing”.
EU Health Commissioner Stella Kyriakides later said that the agency was expected to make its decision “late Wednesday”, adding that she was in “close contact” with the EMA.
Germany and France have both restricted use of the vaccine to older people over fears that younger recipients are potentially more at risk from clots.