NEW DELHI: The Indian Council of Medical Research, on Saturday, defended its order to fast track Covaxin, an indigenous Covid-19 vaccine candidate, as being in line with "globally accepted norms".
The clarification came after its leaked order to 12 hospitals to expedite clinical trials by August 15 sparked widespread criticism.
The country's apex health research body in a statement on Saturday said that "though a large number of vaccines are under various stages of development all across the world, it is also important to promote indigenous vaccine development while at the same time ensuring safety, quality, ethics and adherence to all regulatory requirements."
On July 2, the ICMR director general Dr Balram Bhargava had sent a stern letter to 12 hospitals that have been chosen for clinical trials of Covaxin, being developed by Bharat Biotech (BBIL) in collaboration with the National Institute of Virology.
The initial letter had said the hospitals should get immediate approval from their internal research ethics committee and enrol subjects and complete the trial at the earliest as the government is looking to launch the vaccine for public use by August 15.
It warned that "non-compliance will be viewed very seriously".
The latest statement sought to defend the July 2 letter saying that "after intense characterization and review of all data from BBIL, ICMR is supporting the clinical development as the vaccine candidate appears to be promising."
The clarification said that "ICMR is committed to treat the safety and interest of people of India as a topmost priority".
There was however no mention of the timeline mentioned in the letter nor did it say whether a separate letter will be issued to trial sites.
Based on in-depth scrutiny of the available data from pre-clinical studies, the Drugs Controller General of India has accorded permission to conduct phase 1 and 2 clinical trials, said Saturday's statement, adding that in the larger public health interest, it is important for ICMR to expedite the clinical trials with "a promising indigenous vaccine".
The research body also said that faced with the unprecedented nature of the Covid-19 pandemic, and the consequent dislocation of normal life, all other vaccine candidates across the globe have been similarly fast-tracked.
"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," the statement added.
It also said that the letter by the ICMR DG to investigators of the clinical trial sites was "meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants."
The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay, it said adding that the trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board.
ICMR also said that while issues raised in the public domain from time-to-time by commentators are welcome, as they form an important part of the 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".
But why a deadline, ask experts
Experts said while some countries have fast tracked vaccine trials by allowing safety and immunogenicity phases to go parallelly instead of sequentially, there has never been an instance of any nation setting a deadline to launch a vaccine.
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