New Delhi, October 22: Covaxin, India's first indigenously-developed vaccine candidate against coronavirus (COVID-19), has been cleared by the Drugs Controller General of India (DCGI) for the third phase of clinical trials. Covaxin is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The anti-coronavirus vaccine candidate had shown positive results in preliminary trials. COVID-19 Vaccine: India Has Reserved Nearly Rs 51,000 Crore to Vaccinate All Citizens, Says Report.
According to reports, DCGI's Subject Expert Committee met on Tuesday and has recommended granting permission to conduct phase 3 clinical trial for Covaxin. Bharat Biotech, a Hyderabad-based vaccine maker, had applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission to conduct Phase 3 trials for its COVID-19 vaccine candidate. In its application, the company had said the final stage of testing of its vaccine would involve 28,400 volunteers aged 18 years and above. COVID-19 Vaccine in India: 30 Million, Including Frontline Health Workers, to be Vaccinated in First Phase.
The trials would be conducted in 19 sites - including Delhi, Mumbai, Patna and Lucknow - across 10 states. Two doses of the inactivated virus injection would be given to the participants (0 and 28 days) as part of the Phase-3 human trials. Bharat Biotech has announced Rs 75 lakh insurance cover for the participants in case of any adverse event or effects or death during trials of Covaxin.
The possible side effects of the vaccine could include fever, pain at the site of the intramuscular injection and malaise. India is the manufacturing partner of the vaccine candidate named Covishield, developed jointly by the University of Oxford's Jenner Institute's and AstraZeneca. The Pune-based firm, SII, is looking after the trials at 17 trial sites across India. Besides, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials.
The Russian Direct Investment Fund (RDIF) and Dr Reddy's Laboratories Limited, a global pharmaceutical company headquartered out of India, have agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India. Sputnik V, an adenovirus vector-based vaccine, was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, along with the Russian Direct Investment Fund and registered on August 11.