Covid-19: ICMR’s Aug 15 deadline to vaccine maker stirs a row

NEW DELHI: An Indian Council of Medical Research letter which sought fast-tracking of approvals relating to clinical trials and spoke of the launch of a vaccine by August 15 stirred the medical and scientific community on Friday, with questions being asked on how such deadlines could be adhered to given the complexity and time required for trials on humans.
A vaccine candidate by Bharat Biotech received approval to enter initial phases of human clinical trials only earlier this week. In a letter to Bharat Biotech and chosen hospitals for trials, ICMR director general Balram Bhargava advised “to fast-track all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7” in view of the public health emergency and “urgency to launch the vaccine”.
ICMR has partnered with Bharat Biotech to develop a vaccine called Covaxin. Official sources said the health ministry had asked ICMR about the letter and was informed that the objective was to speed up the processes relating to vaccine development rather than set any hard deadlines. “We need the vaccine at the earliest and that was what ICMR wanted to convey,” a source said. ICMR officials also told TOI that no deadlines were being set.

However, the tone of the letter, suggesting that noncompliance will be treated seriously, generated concern over whether processes were being rushed. “It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however final outcome will depend on the cooperation of all trial sites involved in this project,” Bhargava said.
While calling the vaccine a “top priority” project which was “being monitored at the topmost level of the government”, Bhargava said “non-compliance will be viewed seriously”.