Haryana govt administers COVAXIN to 3 volunteers, 'no adverse effects noted' says Anil Vij

Confirming the commencement of the first phase of human trials for India's indigenous COVID-19 vaccine - COVAXIN, Haryana Health Minister Anil Vij on Friday, said three participants were administered the vaccine at  Post-Graduate Institute of Medical Sciences (PGI) Rohtak. He added that all subjects have tolerated the vaccine well with no adverse effects. ICMR has informed that approximately 1000 human volunteers are under clinical study in various test sites for the two vaccine contentders - COVAXIN (ICMR-NIC with Bharat Biotech) and  ZyCov-D (Zydus Cadilla).

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Haryana's test subjects responding well: Vij 

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The trials phase-1 & 2 have kicked-off combinedly in ICMR shortlisted locations - New Delhi, Patna, Chennai, Kanpur, Gorakhpur, Goa, Bhubaneswar, Rohtak, Hyderabad and Visakhapatnam among others. Volunteers across the country are undergoing assessment for all health parameters such as liver functions and infections and to check if they have COVID-19 infections as trials cannot be done on COVID infected people or even asymptomatic patients. After the assessment, the subjects would be cleared for small doses of one of the two vaccines and the results will be studied.

Human trials for COVID vaccine kick-started with 1000 human volunteers: ICMR

ICMR fast-tracks Covaxin trials

On July 3, ICMR fast-tracked Bharat Biotech India Ltd (BBIL)'s Coronavirus (COVID-19) vaccine - Covaxin & Zydus Cadilla's ZyCov-D'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 and  ZyCov-D were 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.

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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. 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'. Moreover, the Centre has informed a parliamentary panel that a vaccine for COVID-19 is expected only by early next year.