Hyderabad-based firm Hetero Biopharma has received the permission of Drug Controller General of India’s expert panel to start phase 3 trials for the Russian COVID-19 vaccine Sputnik V in India. The Subject Expert Committee (SEC) of DCGI had, on April 13, given its nod for the emergency use of Sputnik V, developed by the Gamalaya Institute with the help of the Russian Direct Investment Fund (RDIF). The expert committee’s approval for emergency use was based on interim data from Russia and the positive results of phase 3 trials conducted by Dr Reddy’s Laboratories (DRL).
In its approval to Hetero Biopharma, the expert panel has asked the firm to study and monitor the vaccine’s immunogenicity on days 21, 24, and 48 of the trial, CNBC-TV18 reported. The company has also been asked to study and assess neutralising antibodies and gamma interferon.
Hetero Biopharma is among the several Indian drug manufacturers that the RDIF has partnered with in order to produce Sputnik V in India. RDIF has reached agreements with Dr Reddy’s Laboratories, Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and is aiming at the production of more than 850 million doses per year in India.
Also, other Indian manufacturers will also be required to conduct bridging trials in order to show bio-equivalence before getting the approval to sell their vaccines.
Regardless of approval, Dr Reddy’s Laboratories, Hetero Biopharma, Gland Pharma, Stelis Biopharma, and Virchow Biotech have already started their production of Sputnik V in order to meet expected demands after the necessary approvals are acquired.
DRL is the only manufacturer that has completed the bridging trials of the vaccine and based on these trials, the DCGI panel had previously given its approval for emergency use authorization to the Russian-made vaccine.
Further, the SEC allowed Bharat Biotech to unblind trial participants in the 18-45 age group, two months after they received the second dose of the vaccine. The panel also asked the company to present a complete safety and efficacy data set for the vaccine, along with a causality analysis of all SAEs, including death.
Sputnik V is the third vaccine to get emergency use approval in India. Bharat Biotech’s Covaxin and AstraZeneca’s Covishield, which is being produced by the Serum Institute of India, are already in use for vaccination across the country.