An Indian Council of Medical Research (ICMR) 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, 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 the Hyderabad-based 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 conducting research on humans, ICMR director general Balram Bhargava advised "to fast-track all approvals”
Vaccine a top priority project: ICMR chief
Bhargava advised speeding up process 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 due to Covid-19 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 said 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 clinical trial sites involved in this project,” Bhargava said in the letter dated July 2. Calling the vaccine a "top priority" project "being monitored at the topmost level”, Bhargava said "non-compliance will be viewed seriously".
