Decision comes after UK regulatory authority confirms trials are safe, and AstraZeneca and University of Oxford say clinical trials will resume in Britain
The trial of an experimental Covid-19 vaccine that was halted after a participant fell ill is set to resume in Mumbai.
The decision comes after the UK’s Medicine Health Regulatory Authority confirmed that the trials were safe, and pharmaceutical giant AstraZeneca and the University of Oxford on Saturday said that clinical trials will resume in Britain.
“The trials have resumed in the UK. There is no reason why they should not start in Mumbai. We will restart the trials in the coming week,” Municipal Commissioner IS Chahal told Mumbai Mirror, adding the Drugs Controller General of India had also issued clearance.
On September 6, the standard review process triggered a voluntary pause to vaccination across all global trials to allow the review of safety data by independent committees, and international regulators, after a participant fell ill.
Pune-based Serum Institute of India, the world’s largest manufacturer of vaccines in terms of volume, and AstraZeneca have partnered together to manufacture the experimental Covid-19 vaccine candidate formulated at the University of Oxford. The Oxford-AstraZeneca vaccine has been named Covishield in India.
In Mumbai trials, the Indian Council of Medical Research is a co-sponsor; the trials are being held at Nair (100 volunteers) and KEM (160) hospitals.
ICMR granted approval to KEM and Nair for Phase 2 and 3 clinical trials of Covishield last month.
A total of 10 medical institutes have been selected for the pan-India vaccine trial.
All volunteers will be tested for Covid-19 through rapid antigen test. Also, they will be examined for Covid-19 antibodies to check if they were ever exposed to the infection in the past and recovered.