(Reuters) – Oxford University said on Tuesday it had halted a small UK trial testing the COVID-19 vaccine it developed with AstraZeneca Plc in children and adolescents, while waiting for more data on rare blood clotting problems in adults. who received the vaccine. Shooting.
The discontinuation of the trial is the latest blow to the vaccine, once hailed as a milestone in the fight against the pandemic, after several countries restricted its use in light of reports of medical problems after vaccines.
There were no safety concerns in the pediatric trial, Oxford University said, adding that it will await guidance from the UK drug watchdog before administering more vaccines.
The university said in February that it planned to enroll 300 volunteers aged 6 to 17, based in the United Kingdom, as part of this study.
The European Medicines Agency (EMA) is reviewing reports of an extremely rare cerebral blood clot known as cerebral venous sinus thrombosis (CVST) after AstraZeneca injections, and is expected to announce its findings on Wednesday or Thursday.
A senior EMA official has said that there is a clear association between the vaccine and CVST, although the direct cause of the clots is still unknown.
The World Health Organization, which is closely studying the latest data on the AstraZeneca vaccine along with other regulators, said Tuesday that it hopes there is no reason to change its assessment that the benefits of the injection outweigh any risks.
Discussions with governments across Europe about the vaccine’s production, supplies, potential side effects and merits have haunted the Anglo-Swedish drugmaker for months.
Anthony Fauci, America’s top infectious disease physician, told Reuters last week that the United States may not need the AstraZeneca vaccine, even if it gets regulatory approval.
Report from Aishwarya Nair, Manas Mishra and Pushkala Aripaka in Bengaluru; Edited by Chris Reese and Ramakrishnan M.