As scientists have expressed both hope and caution on the news that India is fast-tracking the release of its indigenous COVID-19 vaccine, ICMR has clarified that it is adhering to global standards in developing and testing the vaccine.
"Our process to develop vaccine to fight COVID-19 pandemic is as per globally accepted norms of fast tracking," Indian Council of Medical Research said in a statement released Saturday.
"In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine. Faced with the unprecedented nature of the COVID-19 pandemic, and the consequent dislocation of the 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 read.
ICMR also said that the letter by DG-ICMR to investigators of the clinical trial sites was meant to "cut unnecessary red tape, without bypassing any necessary process", and to speed up the recruitment of participants.
ICMR director general Balram Bhargava had written to the principal investigators of the 12 sites of clinical trials and said, "It is envisaged to launch the vaccine for public health use latest by 15 August after completion of all clinical trials."
But the tone of the letter and the haste it indicated had some scientists worried. They questioned the timeline of the announcement mentioned in the letter, and advised against subverting the due vaccine development process.
ICMR, however, pointed towards its reputation and track record to wave aside these concerns.
"ICMR is among the world’s most reputed organisations in the field of medical research and regulation and its track record of facilitating India’s globally respected and acknowledged vaccine and drug industry speaks for itself. Our trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB)," the medical research body said.
ICMR also commented on reports in media where scientists and virologists had expressed doubts over the expedited timeline.
Dr Anant Bhan, a researcher in global health, bioethics and health policy, spoke to Firstpost about the extreme urgency of the situation.
“It’s understandable for a pandemic of this scale. But we can’t compromise on the safety and the efficacy aspects. Minimum standards around safety, efficacy and quality need to be followed. Collapsing the entire process to just 45 days is unlikely, and almost impossible,” he said.
Earlier, PTI too had interviewed several experts who had cautioned against steamrolling a trial and said due processes should be not be cut short.
Virologist Upasana Ray had told the news agency that an accelerated launch or promise for launch of a vaccine against the novel coronavirus deserves applause but it is important to ask whether "we are rushing too much." Ray added that a vaccine normally takes at least 12-18 months to pass all necessary clinical trial phases.
"From now till August 15, the company has just over a months' time to wrap up everything that normally a vaccine development process requires for releasing a vaccine for clinical use," she said.
"How can such a sharp timeline be even decided? Where does the evidence come from that by such a short time all the essential steps will be completed? What about the safety and efficacy, the fundamental steps of any drug development? Have even the pre-clinical studies been completed? Too much rush comes with possible risks," she said.
However, ICMR said that scientists and medical professionals working on the vaccine should not be "second guessed".
"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. ICMR is committed to treat the safety and interest of people of India as a topmost priority," the medical research body said.
from Firstpost India Latest News https://ift.tt/2ZAIB5Z
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