COVID-19: India rejects Sputnik-V vaccine's Phase 3 trial request

New Delhi, Oct 08: Indian drug regulator has rejected proposal to conduct a direct phase-3 clinical trial of the Russian Sputnik V coronavirus vaccine and advised the promoters of the vaccine to carry out a phase-2 trial on Indian subjects first to check the vaccine's s immune response before going ahead with a larger phase-3 study.

The reason behind rejecting is the number of people, who had received Sputnik-V for the initial (phase-1/2) trial in Russia was too small, the Central Drug Standards Control Organisation informed pharmaceutical firm Dr Reddy's Laboratory.

Dr Reddy's Laboratory had tied up with the Russian authorities for clinical trial and subsequent distribution of the vaccine in India, if the trials succeeded.

Drug regulator asked the drugmaker to first test the vaccine in a smaller trial.

The CDSCO rejection may hamper the central government's plan of a quick roll-out of a coronavirus vaccine with the Union Health Minister Harsh Vardhan setting up a target of "receiving and utilising" 400-500 million doses to cover 20-25 crore people.

The regulator noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.

"After detailed deliberation, the committee recommended that the firm should follow the regulatory requirements and conduct Phase 2/3 clinical trials in the country with proper monitoring for humoral and cell-mediated immune response," the regulator wrote.

Results from the early-phase trials of Sputnik V in a total of 76 people - published in the Lancet last month - demonstrated that two formulations of the two-part vaccine exhibited a good safety profile with no serious adverse events detected over 42 days, and induce antibody responses in all participants within 21 days.