ICMR defends fast-tracking Covaxin trials after backlash over August 15 deadline

Indian Council of Medical Research (ICMR) has defended fast-tracking clinical trials for indigenous coronavirus vaccine candidate Covaxin after it faced flak for setting an ambitious August 15 deadline. In a statement on Saturday, country's premier medical research agency said that it is committed to treat the safety and interest of people of India as a topmost priority.

ICMR had written to around 12 medical institutions and hospitals shortlisted for Covaxin trials to fast-track approvals for the vaccine candidate being developed in collaboration with Hyderabad-based Bharat Biotech. ICMR Director General Balram Bhargava had strictly advised all stakeholders to ensure that human volunteer enrolment is initiated no later than July 7, 'in view of public health emergency' and the 'urgency to launch the vaccine'. The ICMR chief envisaged launching the vaccine on August 15.

Medical experts had criticised the push to launch a vaccine within one and a half months as unrealistic. Facing backlash, ICMR assured that the fast-tracked vaccine development process adheres to globally accepted norms while negating hindrances due to red tape and "slow file movement".

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"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," ICMR said in its statement.

"Now that preclinical studies have been completed successfully, the phases 1 and 2 human trials are to be initiated. 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 speed up recruitment of participants," it added.

ICMR assured that best practices and rigour will be followed in Covaxin trials, which will be reviewed, as required, by a Data Safety Monitoring Board (DSMB). "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 medical research agency said.

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A new drug or vaccine usually takes about 10-12 years to complete its journey from lab to market, with development costs surpassing $2.6 billion. It takes about three to six years to identify the target and do pre-clinical studies. Even after receiving permissions for trials, it takes six-seven years to finish tests on humans in three phases. In the case of COVID-19, regulatory agencies are fast-tracking approvals, but the vaccines under trials are not expected to reach the market before next year.

Covaxin is a coronavirus vaccine candidate being developed by Bharat Biotech in collaboration with ICMR-National Institute of Virology, Pune. It was cleared for Phase I and II clinical trials by Drugs Controller General of India (DCGI) only a few days ago after scrutiny of the available data from pre-clinical studies.

Bharat Biotech is also developing two more vaccines for COVID-19 with international alliances. One is with the Thomas Jefferson Institute in the USA using an inactivated rabies virus platform and another named CoroFlu with the University of Wisconsin-Madison and biotech firm FluGen.

Zydus Cadila, one of the first companies globally to initiate research on a COVID-19 vaccine, has also got approval for Phase-I and Phase-II trials for its candidate vaccine ZyCoV-D in India. Zydus has claimed that it has already manufactured clinical batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1,000 subjects.

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