Vaccine efforts aimed at cutting red tape: ICMR
AUG 15 DEADLINE After criticism, research body says trials will follow all global standards
NEWDELHI: The Indian Council of Medical Research (ICMR) on Saturday clarified that its plan to fast-track clinical trials to develop the world’s first Covid-19 vaccine by August 15 – which met with scepticism from the scientific community – was meant to cut “red tape” and speed up the process without “bypassing any necessary” processes.
The clarification came a day after the July 2 directive by the country’s topmost medical research body triggered disbelief among scientists who said that the process of developing a vaccine requires painstaking trials and analysis, and cannot reliably be completed in just six weeks.
“ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel,” according to the ICMR’s statement on Saturday.
“Our trials will be done following the best practices and rigour, and will be reviewed, as required,” it added.
The July 2 letter by ICMR chief Dr Balram Bhargava’s to the heads of 12 institutes had asked them to secure necessary approvals for human trials for the vaccine candidate by July 7 with a warning that “non-compliance will be viewed very seriously”.
The vaccine, Covaxin, has been jointly developed by ICMR and Hyderabad-based Bharat Biotech (BBIL).
Clinical trials include a clutch of tightly monitored inoculation among sets of volunteers to test whether a vaccine is safe and works – a process that on average has taken over 10 years. In a pandemic, this timeline can be compressed, but most experts believe that is still likely to take 12-18 months – making India’s plans on Covaxin scientifically implausible.
Despite Saturday’s clarification that described the letter as an attempt to cut red tape, senior scientists said that the incident as not just tarnished the credibility of an institute setting standards and guidelines for clinical research since 1911, but also of scientific research in India.
“It has lowered the credibility of ICMR, and along with that of India’s scientific community,
regulatory system government, and the potential vaccine... its reputation is dented before it is even ready...That reputation has taken a beating,” said Dr T Jacob John, virologist and former professor at Christian Medical College, Vellore, Tamil Nadu.
Bharat Biotech, which is among seven Indian firms working on Covid-19 vaccines and the first to get the regulatory nod to begin the human trials, plans to enroll 375 people in the first phase of clinical trials and 750 people in the second phase, an ICMR spokesperson said.
Whether the vaccine will be approved for general use depends on the outcomes of those trials, he said.
A spokesperson for Bharat Biotech declined to comment on the August 15 timeline in the ICMR’s letter.
A SPOKESPERSON FOR BHARAT BIOTECH DECLINED TO COMMENT ON THE AUG 15 TIMELINE IN THE ICMR’S LETTER