The Indian Council of Medical Research on Saturday defended its direction to clinical trial sites of Covaxin to fast-track approvals and launch it by August 15. This was in accordance with global norms to fast track vaccine development, the top medical body claimed amid criticism that the deadline was unscientific and unrealistic.
Covaxin was the first indigenous vaccine to get permission for human trials by the Drug Controller General of India, on June 29. It has been jointly developed by a Hyderabad-based private firm Bharat Biotech, the Indian Council for Medical Research and the National Institute of Virology. The first and second phase of its clinical human trials are scheduled to begin from July.
“In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine,” the ICMR said in a press release. “Faced with the unprecedented nature of the COVID-19 pandemic, and the consequent dislocation of the normal life, all other vaccine candidates across the globe have been similarly fast-tracked.”
ICMR said that its letter to the clinical trial sites was meant to cut unnecessary red tape but without skipping the necessary process. “The aim is to complete these phases [one and two of human trials] at the earliest, so that population-based trials for efficacy could be initiated without delay,” ICMR clarified. The medical body added that the safety and interest of the people would remain its top priority.
On Thursday, ICMR Director General Balram Bhargava had written a letter to 12 hospitals and medical institutions involved in the clinical trials of Covaxin, asking them to fast track all approvals and ensure that the subject enrolment is done by July 7. The top medical body warned trial sites that any kind of non-compliance to the order will be viewed “very seriously”.
- ICMR asks clinical trial sites of Covid-19 vaccine to fast-track approvals for August 15 launch
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Health experts had raised concerns about ICMR’s letter, questioning the way the organisation put pressure on the ethics committees of the 12 institutions to expedite approvals.
Meanwhile, a second vaccine candidate, developed by Gujarat-based firm Zydus Cadila, has also received approval to conduct phase one and two human trials.
More than a dozen coronavirus vaccine candidates across the world are in clinical trials and 125 candidate vaccines in precical evaluation, according to the World Health Organization. One of the leading candidates in terms of timing is the University of Oxford and AstraZeneca’s Covid-19 experimental vaccine.