After being denied their request to conduct a phase three clinical trial with Russia's Sputnik V covid-19 vaccine and asked to submit a new request, the Controller General of Medicines of India (DCGI) has given Dr Reddy's Laboratories its approval.
The big pharma will conduct Phase 2-3 clinical trials of the vaccine instead of jumping straight to Phase 3. The reason the first request was overturned was due to a lack of sufficient safety and efficacy data on the Russian vaccine.
GV Prasad, co-chairman and managing director of Dr Reddy's, said in a statement, “We are grateful for DCGI's scientific approach and support in the application process."
"Regulatory approval provides an opportunity to initiate clinical trials in India and further supply a safe and effective vaccine to combat the pandemic,” he added.
After the first application was evaluated by the Subject Expert Committee (SEC) on COVID-19 at Central Drugs Standard Control Organisation (CDSCO), the regulator said Dr Reddy's cannot directly conduct a phase 3 trial for the COVID-19 vaccine. This, since the sample size of early human trials for the vaccine carried out in Russia, was "small", and information of its safety and the immunogenic effect was insufficient for Indian subjects.
CDSCO had asked Dr Reddy’s to submit a revised application, which includes new protocols for both phase 2 and phase 3 human clinical trials instead of just phase 3. A PTI report states that the pharma giant was asked to submit additional information as well, but as to what was specified, it is unclear.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF) said in a statement, "We are delighted to be working with regulatory authorities in India and will provide data on the safety and immunogenicity of the vaccine from Phase 3 trials in Russia, in addition to data from clinical trials in India to facilitate successful Sputnik V trials in the country."
India, overlooked by Dr Reddy's will be conducting a multicenter, randomized controlled trial, which will include safety and immunogenicity trials. RDIF will also supply 100 million doses of Dr Reddy's after receiving Indian regulatory approval.
The on-going post-registration Sputnik V vaccine trials are being conducted in Russia on 40,000 volunteers as well as in Belarus, Venezuela and the United Arab Emirates.
source https://www.firstpost.com/health/dcgi-approves-dr-reddys-request-to-conduct-phase-2-3-clinical-trials-with-russias-sputnik-v-covd-19-vaccine-8929031.html
