Oxford pauses trial testing AstraZeneca vaccine in kids
OXFORD : TheUniversity of Oxford said on Tuesday it had paused a small British trial testing the Covid-19 vaccine it developed with AstraZeneca in children and teenagers, as it waits for more data on rare blood clotting issues in adults.
The trial disruption 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 issues after inoculations.
There was no safety concern in the paediatric trial, Oxford University said, adding that it would await guidance from the British drug watchdog before giving any further vaccinations. The university said in February it planned to enrol 300 volunteers aged six to 17, based in Britain, as part of this study.
The European Medicines Agency (EMA) said yesterday that blood clots should be listed as a "very rare" side effect of the AstraZeneca coronavirus vaccine but that the jab's benefits continue to outweigh the risks.
"EMA's safety committee has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects" of the shot, the Amsterdam-based EU drug regulator said in a statement.
A senior EMA official had earlier said there is a clear association between the vaccine and blood though the direct cause of the clots is still unknown.
The World Health Organisation, which is closely studying the latest data on AstraZeneca's vaccine alongside other regulators, said it expects there will be no reason to change its assessment that the shot's benefits outweigh any risks.
Spats with governments across Europe about production, supplies, side effects and the vaccine's merits have dogged the Anglo-Swedish drugmaker for months.
Dr Anthony Fauci, the top US infectious disease doctor, said last week the US may not need AstraZeneca's vaccine even if it wins regulatory approval. - REUTERS