Bharat Biotech’s COVID-19 vaccine candidate Covaxin could be launched as early as February 2021, a scientist at the Indian Council of Medical Research (ICMR) has told Reuters. The scientist also added that the last-stage trials have shown that the vaccine is safe and effective. Dr Rajni Kant, a scientist at ICMR and a member of the national task force on COVID-19, said that the vaccine has shown good efficacy and that it will be expected by “the beginning of next year, February or March, something would be available.” If Covaxin is launched in February, it will be the first vaccine to be rolled out in India.
Bharat Biotech recently received approval to conduct Phase III human trials of India's first indigenous coronavirus vaccine, Covaxin, and Sai Prasad, Executive Director, Bharat Biotech International Limited (BBIL), had told IANS that it was found to be safe without any major adverse events in the first two stages of the trials involving about 1,000 participants.
Bharat Biotech had announced on June 29 that it had successfully developed Covaxin in collaboration with ICMR and National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune, and transferred to Bharat Biotech. The vaccine candidate has been developed and manufactured in Bharat Biotech's high containment facility located in Genome Valley, Hyderabad. The Phase I trials began in July while Phase II trials started in September.
In September, Union Health Minister Harsh Vardhan had said in Parliament that the coronavirus vaccine will be made available in the country by the start of next year.
The other indigenous vaccine by Zydus Cadila has also completed phase 2 trials and is expected to submit the data to the Drugs Controller General of India (DCGI). Serum Institute of India (SII) has again commenced the trials after getting clearance from the Drug Controller General of India. 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 this, 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.