(Reuters) – Oxford University said on Tuesday it had stopped a small UK trial to test the COVID-19 vaccine it developed with AstraZeneca Plc in children and adolescents, while awaiting more data on rare blood clotting problems. blood in adults who received the shot.
The interruption of the trial is the latest hit against 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 inoculations.
There were no safety issues in the pediatric trial, said Oxford University, which added that it would wait for the guidance of the UK drug surveillance dog before making more vaccinations.
The university said in February that it planned to enroll 300 volunteers aged 6 to 17, based in the UK, as part of this study.
The European Medicines Agency (EMA) is currently reviewing reports of an extremely rare cerebral blood clot known as cerebral venous sinus thrombosis (CVST) following AstraZeneca traits and is expected to announce its findings. Wednesday or Thursday.
A senior EMA official has said 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 alongside other regulators, said Tuesday that it hopes there is no reason to change its assessment that the benefits of the shot overcome the risks.
Negotiations with governments across Europe on production, supplies, possible side effects and vaccine merits have haunted the Anglo-Swedish drug maker for months.
Anthony Fauci, the top U.S. infectious disease doctor, told Reuters last week that the United States may not need the AstraZeneca vaccine, even if it gets regulatory approval.
Reports of Aishwarya Nair, Manas Mishra and Pushkala Aripaka in Bengaluru; Edited by Chris Reese and Ramakrishnan M.