NEW DELHI: India’s apex drug regulator has rejected a proposal by pharmaceutical major Dr Reddy’s Laboratories to directly conduct phase 3 trial for Russian Covid-19 vaccine Sputnik V directly in India saying that the sample size for early human trials for the vaccine was “small”.
The regulator has now asked the Hyderabad-based firm, which has entered into a partnership with Russia for the local clinical trials and mass distribution of vaccine in India, to submit a revised proposal for phase 2 and 3 trials in the country.
A subject expert committee of the Drug Controller General of India, on Monday, in response to a proposal by the DRL noted that the safety and immunogenicity data in overseas phase 1 and 2 studies is “small” and insufficient for Indian subjects.
“After detailed deliberation, the committee recommended that the firm should follow the regulatory requirements and conduct phase 2/3 trial in the country with proper monitoring for humoral and cell mediated immune response,” the committee instructed.
It added that accordingly, the firm should submit the protocol for consideration of the committee.
Under the revised plan, the vaccine, which includes two adenovirus vectors, modified to express the SARS-CoV-2 spike protein, will have to be first assessed in a small group of volunteers to study its efficacy before it can be tested on a larger population.
The development comes less than a month after the Russian government announced its partnership with DRL for mass vaccinations by the year-end.
Under the plan, the Russian Direct Investment Fund which is leading the Covid-19 vaccine project in Russian plans to supply 100 million doses to Dr Reddy’s, upon regulatory approval.
Queries seeking responses from both Dr Reddy’s and the RDIF on the development remained unanswered.
Sputnik V, which was found to be safe and effective in about 70 volunteers in Russia in phase 1 and 2 trials, as per a paper published in the Lancet, is currently under phase 3 trial involving 40,000 individuals.
As per the details of the trials published, the vaccine induced antibody responses in all participants within 21 days.
On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology had been registered by the ministry of health of Russia and became the world’s first registered vaccine against Covid-19.
While announcing its partnership with DRL, RDIF had claimed that more than 55,000 volunteers had applied to take part in post-registration trials and the first results of these trials are expected to be published in October-November.