Fast tracking Covid-19 vaccine trials in keeping with globally accepted norms: ICMR
The country’s apex medical research body had written to 12 institutes selected for human trials expressing its aim to launch the vaccine by August 15
The fast tracking of clinical trials of the Covid-19 vaccine candidate being developed by Indian firm Bharat Biotech is in keeping with globally accepted norms, the Indian Council of Medical Research (ICMR) said on Saturday.
Clarifying its move to set an August 15 deadline for completion of clinical trials of the drug Covaxin, the country’s apex medical research body said human and animal trials can be taken up in parallel “to fast track the vaccine development for diseases of pandemic potential”.
“In the larger public health interest, it is important for ICMR to expedite clinical trials with a promising indigenous vaccine. Faced with the unprecedented nature of the Covid 19 pandemic, all other vaccine candidates across the globe have been similarly fast-tracked,” ICMR said.
In a letter to 12 institutes selected for human trials of Covaxin, it had asked them to secure necessary internal approvals by July 7 and said that it aimed to launch the vaccine on Independence Day.
Several experts had raised questions about the safety of such accelerated trials but the ICMR has rejected the allegations of rushing through with the process..
“The letter by the ICMR Director General to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants,” the medical research body said.
According to ICMR, the aim was to complete these phases at the earliest so that population-based trials for efficacy could be initiated without delay.
Maintaining that the safety and interest of the people of India was its “topmost priority”, ICMR said the Drugs Controller of India had given its nod for Phase 1 and 2 clinical trials after an in-depth scrutiny of the data available from pre-clinical studies.
Bharat Biotech is one of seven Indian firms working to develop a Covid-19 vaccine and was the first to receive approval for clinical trials from the Drug Controller of India.