Oxford COVID-19 vaccine: Serum Institute to resume trial in India after DCGI's nod1 min read . Updated: 12 Sep 2020, 10:04 PM IST
- The recent chain of events are a clear example why we should not bias the process and should respect the process till the end, said Adar Poonawalla
After Astrazeneca resumed Oxford University coronavirus vaccine trial in the United Kingdom, Serum Institute of India on Saturday said that they will restart the trial in the country once the apex drug regulator allows. Commenting on the resumption of trial, Adar Poonawalla, the chief executive officer of Serum Institute of India said, "We should not jump to conclusions until the trials are fully concluded."
AstraZeneca paused its trials late Tuesday after observing “a single event of an unexplained illness that occurred in the UK phase III trial". Later, Pune-based drug maker suspended the clinical trials of Oxford COVID-19 vaccine in the country. The vaccine maker took the decision based on instructions from the Drug Controller General of India (DCGI) V.G. Somani. On Wednesday, the central drug regulator issued a show-cause notice to the company, asking it to explain why it was not informed about AstraZeneca pausing the clinical trial of the Oxford coronavirus vaccine candidate.
Commenting on the resumption of trial in India, Poonawalla said, "The recent chain of events are a clear example why we should not bias the process and should respect the process till the end."
Oxford University said in a statement that the UK regulator had recommended that the trials resume after an independent review of the safety data. "The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume," said the Astrazeneca.
AstraZeneca's pause of an experimental vaccine for the coronavirus after the illness of a participant is a "wake-up call" but should not discourage researchers, the World Health Organization's (WHO) chief scientist earlier said. "This is a wake-up call to recognise that there are ups and downs in clinical development and that we have to be prepared," Soumya Swaminathan told.
Serum Institute of India partnered with AstraZeneca to manufacture the Oxford COVID-19 vaccine candidate for low-and-middle income countries. Pune-based vaccine maker earlier shortlisted 17 sites in India for the Phase II clinical trial of COVID-19 vaccine. At least 1,600 candidates aged between 18 to 55, will participate in the trial.