4 yıl önce

Clinical trial of AstraZeneca's Covid-19 vaccine resumes in five countries

Global trials of the leading vaccine were put on hold last month after a British study participant fell ill with what was believed to be a rare spinal inflammatory disorder.

Reuters

Clinical trials on one of the most advanced experimental Covid-19 vaccines were paused Tuesday after a volunteer developed an unexplained illness, September 9, 2020.

Clinical trials of AstraZeneca and Oxford University's experimental Covid-19 vaccine has resumed in five countries almost a month after being put on hold due to an illness of a British volunteer, while discussions with US authorities continue.

Trials in Japan, UK, Brazil, South Africa and India resumed, but US trials remain paused as regulators widened their probe on Wednesday.

In a statement on Friday, the pharmaceutical giant stressed that safety of the participants was of "paramount importance" and that it was applying the highest standards of conduct in trials.

Global trials of the vaccine, called AZD1222 or ChAdOx1 nCoV-19, were put on hold on September 6 after a study participant fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.

Investigation of the halt

AstraZeneca has called the halt a standard review procedure, and a document posted online by Oxford university last month stated the illness may not have been associated with the vaccine.

However, the incident has drawn focus on the safety of candidates being developed in the race for a successful vaccine against the illness caused by the novel coronavirus which has claimed more than a million lives globally.

The US Food and Drug Administration (FDA) broadened its investigation of the illness in the volunteer, and would look at data from earlier trials of similar vaccines developed by the same scientists.

Sources had told Reuters that the data requested by the FDA for one of the most advanced Covid-19 vaccine candidates in development was expected this week.