Serum Institute of India (SII) said on Thursday (September 10) that it would pause the ongoing clinical trials in India of the Covid-19 vaccine candidate developed by the University of Oxford.
The move follows a show-cause notice issued by the drug regulator to the Pune firm over a single adverse reaction that was detected at one of the global trial sites.
SII is sponsoring mid- and late-stage human clinical trials for the vaccine candidate in India.The firm, the world’s largest vaccine manufacturer, has been contracted by the Swedish-British pharma giant AstraZeneca and the University of Oxford to manufacture the vaccine for low- and middle-income countries.
However, vaccination resumed after the DSMB completed its investigations and gave the green light for trials to continue, according to Christian Medical College Vellore professor and former
Translational Health Science and Technology Institute executive director Dr.Gagandeep Kang, who played a key role in the developing this vaccine.
Researchers say that adverse events are likely to occur in large studies like these and that pausing the testing is “part and parcel” of any vaccine trial.