The clinical trials of the Oxford vaccine will continue in India as usual as it has faced no issue at all, the Serum Institute of India (SII) said over the recent report of the phase-three study of the Covid-19 vaccine being put on hold in the United Kingdom, as one of the participants reported an "unexplained illness."
Earlier, the Drugs Controller General of India (DGCI) on Wednesday, issued a show-cause to the institute asking why the firm had not informed the drug regulator body about the unexpected illness in one of the patients in the UK even as testing continues at 17 sites within the country.
However, this illness has caused 4 countries to put Covid-vaccine trials on hold.
DGCI VG Somani through a notice sought to know why the institute could not suspend the trials for Phase 2 and 3 till the time patient safety is not established. The SII, later on, Wednesday, reverted to it and said there was no explicit directive yet to pause the trials.
Besides this, SII has also not submitted a casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of Phase 2 and 3 clinical trials of the subject vaccine in the country in the light of safety concerns, the DCGI said.
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On the other hand, the SII cleared the air on the impending trials of the vaccine in India.
Commenting on the situation, SII CEO Adar Poonawala said, " As far as Indian trials are concerned, it is continuing and we have faced no issues at all."
"The vaccine is completely safe," he added.
We are going by the DCGI's direction, and so far haven't been told to pause the trials. If the DCGI has any safety concerns, we will follow the instructions and abide by the standard protocols.
A total of 100 volunteers in India have already received the trial dose of the Covishield vaccine, which, if certified safe, will be manufactured by Serum Institute in India.