ICMR clarifies intent of Aug 15 deadline for COVID vaccine; says 'trials yet to begin'

Addressing the monthly Coronavirus (COVID-19) press briefing, Health Ministry's Officer on Special Duty (OSD) Rajesh Bhushan, on Thursday, clarified ICMR's controversial August 15 deadline. He said that ICMR- DG Balram Bhargava's letter was intended to 'expedite duly approved clinical trials without compromising on safety & security concerns'. He added that while the locations of the trials had been finalised, the trials are yet to begin.

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ICMR: 2.6 lakh tests per day

Meanwhile, ICMR's senior scientist Nivedita Gupta, informed that India tests more than 2.6 Lakhs of samples per day, on average. Opining on the ICMR's vaccine deadline, she said, "We want to develop a vaccine as fast as possible. Letter of ICMR DG intent was to fast track the process", adding "If we produce a vaccine 2 years later, it will be of no use". Moreover, India currently has 1132 testing labs and over 452 randomised trials had taken place under ICMR.

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ICMR fast-tracks Covaxin trials

On Friday, ICMR fast-tracked Bharat Biotech India Ltd (BBIL)'s Coronavirus (COVID-19) vaccine - Covaxin's clinical trials. In an official statement, ICMR Director General Balram Bhargava stated that ICMR aims to launch the indigenous COVID-19 vaccine by August 15. Covaxin was approved by the DCGI recently to proceed to clinical trials after it showed promise in its pre-clinical data.

The country's apex medical body has selected 12 institutes across the country and has advised them to expedite approvals and complete recruiting for the trials by 7 July. "Kindly note that non-compliance will be viewed seriously," the letter states, adding that the institutions must treat this project on the highest priority and meet the given timelines without any lapse. Apart from Odisha, institutes selected for the clinical trial are located in Visakhapatnam, Rohtak (Haryana), New Delhi, Patna, Belgaum (Karnataka), Nagpur (Maharashtra), Gorakhpur, Kanpur (UP), Kattankulathur (Tamil Nadu), Hyderabad, Arya Nagar and Goa.

Scientists question 'rushed vaccine' deadline

Reacting to the ICMR letter, several experts had raised fears that its safety and efficacy could be compromised. Moreover, scientists have disapproved the strict and 'nearly impossible' timeline set by ICMR with an aim to launch the vaccine by August 15. Scientists have also questioned the feasibility of mass production of the vaccine if desired results are achieved. ICMR has defended its move stating that they are committed to treating public safety as the topmost priority and said that the process followed by the apex medical body is in 'accordance with the globally accepted norms to fast-track vaccine development'.

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