"In the larger public health interest, it is important for ICMR to expedite clinical trials with a promising indigenous vaccine," said ICMR about an ambitious timeline for India's first potential coronavirus vaccine -- from human trials to general use in six weeks.
The ICMR said that the letter by Director General of ICMR Dr Balram Bhargava to principal investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.
Just as red tape was not allowed to become a hindrance in the fast track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement, it said.
"The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay," ICMR said in a statement.
Bharat Biotech International Ltd., an unlisted vaccine maker, received the regulatory nod to start human clinical trials for its experimental shot only earlier this week but it already has India’s apex medical research body expediting the process.
The under-development vaccine is “envisaged" to be rolled out “for public health use by Aug. 15 after completion of all clinical trials," ICMR said in a July 2 letter to clinical trial sites. It “is one of the top priority projects which is being monitored at the topmost level of the government."
"While issues raised in public domain from time-to-time by commentators are welcome, as they form an important part of feedback loop, the best of India’s medical professionals and research scientists should not be second guessed for their professionalism or adherence to the highest scientific rigour," the statement stated.
"ICMR is committed to treat the safety and interest of people of India as a topmost priority," it said.
The Indian Council of Medical Research(ICMR) has identified 12 clinical trial sites, including medical institutions and hospitals, and has asked their principal investigators to ensure that the subject enrolment is initiated no later than July 7.
There’s been no evidence yet that Bharat Biotech’s vaccine is safe for use on humans, not to mention effective. The envisioned timeline is markedly shorter than other front-runner vaccine efforts from American and Chinese drugmakers, most of which started human clinical trials months ago and are now entering the last of three stages of testing.
All other vaccine candidates across the globe have been similarly fast-tracked, it said, adding that the Drugs Controller General of India has accorded permission to conduct phase 1 and 2 (human) clinical trial of 'Covaxin' based on in-depth scrutiny of the available data from pre-clinical studies.
"Faced with the unprecedented nature of the Covid-19 pandemic, all other vaccine candidates across the globe have been similarly fast-tracked," said ICMR in its release.
"ICMR’s process is exactly in accordance with globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel," said the apex medical research body on Saturday.
Bharat Biotech plans to enroll 375 people in the first phase and 750 people in the second phase of clinical trials, said an ICMR spokesperson. Whether the vaccine will be approved for general use depends on the outcomes of those trials, he said.
The trial will start “most probably" by Monday, said C. Prabhakar Reddy, a professor in Hyderabad’s Nizam’s Institute of Medical Sciences -- one of the trial sites that received ICMR’s letter. “We are all working day and night to meet the deadline but still it will be neck to neck race," he told Bloomberg, adding that he doesn’t anticipate any shortage of volunteers “in the current scenario."
The apex research body on Friday wrote to select medical institutions and hospitals to fast-track clinical trial approvals for the coronavirus vaccine candidate Covaxin being developed in collaboration with Bharat Biotech which it plans to release on August 15.
The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.
ICMR and Bharat Biotech are jointly working for the preclinical as well as clinical development of this vaccine, a letter by ICMR mentioned, reported ANI.