The Drugs Controller General of India (DCGI) has approved Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) to carry out the late-stage trials of Russia’s COVID-19 vaccine Sputnik V in India.
According to the statement, an adaptive phase 2 and 3 human clinical trials involving around 1,500 participants would be carried out in India which will include safety and immunogenicity study.
Russia is reported to be conducting phase 3 trials of Sputnik V in several other countries including Belarus, Venezuela, and the United Arab Emirates (UAE).
Dr Reddy’s Laboratories and the RDIF will jointly conduct the trials in which the latter will supply 100 million doses of Sputnik V vaccine.
Meanwhile, Serum Institute’s (SII) Executive Director Dr Suresh Jadhav was recently quoted saying that India would have 200-300 million doses of the Oxford University developed COVID-19 vaccine AZD1222 ready by the end of December and that the final tested vaccine will be available by March 2021.
He said the Serum Institute is working on five different products to combat the coronavirus pandemic. Once the license is given by the DCGI, the products can be launched in the country.
In a related development, India’s Prime Minister Narendra Modi on Saturday reviewed the COVID-19 pandemic situation in the country and the preparedness of vaccine delivery, distribution, and administration.
As many as three COVID-19 vaccines are in advanced stages of development in India, out of which two are in Phase II and one is in Phase III, said an official statement issued by the government.
Indian scientists and research teams are also collaborating and strengthening the research capacities in neighbouring countries. Modi said India should not limit its efforts to the immediate neighbourhood, but also reach out to the entire world in providing vaccines, medicines and other platforms for vaccine delivery system.