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As UK approves Pfizer, what’s status of made-in-India Covaxin’s trials?
Phase 3 human trials of a COVID vaccine candidate were launched in Karnataka on December 2. Chief Minister BS Yediyurappa virtually inaugurated the trials of Bharat Biotech’s Covaxin on the same day that the United Kingdom cleared the Pfizer-BioNTech vaccine for use. Its doses are likely to be available in UK from next week. Many other states are currently conducting phase 3 trials of Covaxin, which was indigenously developed in India.
Bharat Biotech is conducting phase-3 clinical trials in partnership with top medical body Indian Council of Medical Research (ICMR).
The trials of its COVID-19 vaccine candidate — Covaxin — which involves 26,000 participants across 22 sites in the country, began on 16 November. It is the largest clinical trial conducted for a coronavirus vaccine in India.
The Covaxin phase 3 trials have commenced in several states in the country, including Delhi, Karnataka and Bengal, and many other states are expected to begin soon.
States that have started the phase 3 trials of India’s first COVID-19 vaccine:
1) Haryana – Haryana became the first state to start Covaxin phase 3 trials on 20 November with state home minister Anil Vij being the first volunteer to be administered a trial shot. Vij was administered the trial dose at the Civil Hospital at Ambala Cantt.
2) Delhi– The phase 3 human clinical trial of Covaxin began at the AIIMS in the national capital on 26 November. The trial began as Dr M V Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers received the first dose. The trail doses were reportedly given to around 15,000 volunteers in Delhi’s AIIMS.
3) West Bengal: Governor Jagdeep Dhankhar today inaugurated the launch of Phase-3 regulatory trial of Covaxin at Kolkata’s ICMR-National Institute of Cholera and Enteric Diseases (ICMR-NICED), lauding India’s leadership for “effectively tackling” the novel coronavirus pandemic. Bengal minister Firhad Hakim became the first volunteer to take the Covid-19 vaccine ‘Covaxin’.
4) Gujarat: Phase 3 trials of Covaxin commenced in Gujarat on 26 November at Ahmedabad’s Sola Civil Hospital, the only site in the state where the exercise will be carried out. The Sola civil hospital is one among the 130 centres across the country where the third phase of clinical trials of Covaxin would be conducted.
5) Odisha – The third phase human trial of Covaxin, the much-awaited indigenously developed Covid-19 vaccine, began at an institute in the state on 20 November. The vaccine was administered to two recruits at the Preventive and Therapeutic Clinical Trial Unit (PTCTU) at the Institute of Medical Sciences and SUM Hospital, the only institute in Odisha chosen by the ICMR for the human trial of the vaccine.
6) Madhya Pradesh – People’s University in Bhopal is the site for phase 3 trials of Covaxin in Madhya Pradesh. The trial vaccination had started on 27 November.
Besides the Hyderabad-based firm’s Covaxin in the country, four other potential vaccines are under various phases of human clinical trial with the Serum Institute of India conducting phase-three trial of the Oxford-Astrazeneca Covid-19 vaccine while the indigenously developed vaccine by Zydus Cadila has completed phase-two clinical trial. – MB Bureau
