Sputnik V Covid-19 vaccine gets nod for clinical trials in India

Grant Boone
October 18, 2020

As the work continues to develop an effective vaccine for COVID-19, the government on Saturday said two pan-India studies on the genome of the virus in India suggest it is genetically stable and has shown no major mutation.

But even as 11 Chinese vaccines have entered clinical trials - with four in advanced Phase Three trials - none have been approved for mass market distribution.

Dr Sander van der Linden, who is director of the Cambridge Social Decision-Making Lab and one of the authors on the study, said: 'We find a clear link between believing coronavirus conspiracies and hesitancy around any future vaccine. Spokesperson Dmitry Peskov said the accusation makes no sense and that Russian Federation is not giving anyone false information.

Russian Federation has been granted approval by the Drug Control General of India (DGCI) to conduct late-stage clinical trials of Sputnik V COVID-19 vaccine in India.

According to sources, it would be multi-centre, observer-blind, randomised controlled study. "We are committed to bringing in a safe and efficacious vaccine to combat the pandemic", he said.

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Dr. Reddy's and Russian Direct Investment Fund (RDIF) had last month announced a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. Around 40,000 volunteers are expected to receive Sputnik V during the phase 3 trial now underway in Russian Federation. "After detailed deliberation the committee recommended that the company should follow the regulatory requirements and conduct Phase II/III clinical trial in the country with proper monitoring for humoral & cell mediated immune response", the committee had said while asking Dr Reddy's to submit a revised proposal with the protocol for conducting Phase II and III studies.

In addition, the RDIF, together with its partners, is conducting Sputnik V clinical trials in Belarus, the United Arab Emirates, and Venezuela.

"India may get COVID-19 vaccine by March 2021 provided the regulators speed up the process as multiple manufacturers are working on it", Jadhav said at the India Vaccine Accessibility e-summit organised by HEAL Foundation in association with ICCIDD.

Earlier, Union health minister Harsh Vardhan had said that the Indian Council of Medical Research has been conducting large-scale sequencing of nationally representative strains of SARS-CoV-2 virus collected for several months over different time periods.

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