Dr Balram Bhargava’s July 2 directive to lead researchers of several institutions chosen as test sites to complete clinical trials soon so as to have the world’s first Covid-19 vaccine ready on August 15 has dented the credibility of India’s apex medical research body that he heads, say top scientists, government officials, and public health experts, who are not buying the research’s agency argument that the letter was an effort to speed up vaccine trials.
A day after some of the country’s top scientists and medical experts described as unreasonable and absurd an ICMR timeline to produce a Covid vaccine for public health use latest by August 15, the Council has claimed that its letter to clinical trial sites, which mentioned the date, was meant to cut unnecessary red tape. In a statement issued Saturday, ICMR said: “The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay.”
The potential vaccine is being developed by Bharat Biotech, a Hyderabad-based pharmaceutical company, in partnership with Pune-based National Institute of Virology, an ICMR laboratory. The Sunday Express has learnt that a scheduled virtual meeting Saturday of the principal trial investigators with ICMR and Bharat Biotech was postponed.
The letter has triggered outrage among experts with AIIMS Director Randeep Guleria describing the deadline as a very challenging and difficult task, considering that we have to look at both efficacy and safety of any vaccine that is introduced. “Also, if we get the desired results, the other challenge is the process of mass production of the vaccine,” Guleria told this newspaper.
In a background note circulated the day it received approval for clinical trials, vaccine developer Bharat Biotech had said that the results of Phase I and Phase II trials would be out only by October. The two phases are yet to be approved by the institutional ethics committees of six of the 12 selected hospitals, a mandatory requirement before the trial can begin.
– sahej kapoor