Dr Reddy’s asked to resubmit phase 2,3 trial application for Russia’s Sputnik V COVID-19 vaccine by DCGI
Dr Reddy’s trials 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.
Hyderabad-based Dr Reddy’s Laboratories has been asked to resubmit their application to conduct clinical trials with the Russian Sputnik V vaccine in India. The report comes after the company’s first request was overturned, due to a lack of sufficient safety and efficacy data on the Russian vaccine.
After the 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 were “small”, and information of its safety and immunogenic effect was insufficient for Indian subjects.
CDSCO has 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.
“…Dr Reddy’s laboratories will have to submit a new application. According to the SEC, they have to conduct both phase 2 and 3 clinical trials and cannot directly hold a phase 3 trial for the vaccine in India,” a source said.
The committee stated, as per a report in the New Indian Express, “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.”
According to other sources, the trial will be a multi-centre, observer-blind, randomised controlled study. The New Indian Express also reported that Dr Reddy’s trials 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 lab is collaborating with the Russian Direct Investment Fund (RDIF) to conduct trials as well as distribute the vaccine once it gets the necessary approvals. They will provide Dr Reddy’s with 100 million doses of the vaccine for distribution.
Also Read: RDIF, Dr Reddy’s Lab tie up for Sputnik V human trials, distribution of 100 mn doses of the COVID-19 vaccine in India
About Sputnik V
The vaccine has been developed by the Gamaleya Institute along with Russia’s Defense Ministry uses a different virus – the common cold-causing adenovirus – that’s been modified to carry genes for the “spike” protein that coats the coronavirus, as a way to prime the body to recognize if a real COVID-19 infection comes along.
The vaccine is similar to others being developed by China’s CanSino Biologics and Britain’s Oxford University and AstraZeneca.
The vaccine is supposedly given in two doses and will help people develop immunity to the virus for at least two years.
With inputs from PTI
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