Drug Regulator Of India Declines To Test Sputnik-V In Large Study

Drug Regulator Of India Declines To Test Sputnik-V In Large Study

Drug regulator of India has rejected a proposal from Dr Reddy’s Lab Ltd for conducting a large scale study in the country to evaluate Russia’s Sputnik-V Covid-19 vaccine. Drug regulator of India has asked that the trial should be conducted first on a smaller level.

An expert panel of the CDSCO (Central Drugs Standard Control Organisation) noted that data collected overseas from the early-stage studies regarding the safety and immunogenicity were small. Moreover, there were no data from Indian participants. 

Russia is planning to roll out the vaccine without even completing its full trials. India’s rejection to conduct a large scale study of the Sputnik-V vaccine in India has come as a setback to Russia. 

India is expected to overtake the United States over the next several weeks as the country with the world’s largest number of cases.

The Sputnik-V is being marketed by the Russian Direct Investment Fund (RDIF). Last month, RDIF and Dr. Reddy’s Lab announced that they are partnering to run clinical trials and distribute the Sputnik-V Covid-19 vaccine in India.

Russia became the first country to grant regulatory permission for the vaccine of novel coronavirus. Russia approved before even completing the large-scale trials of the vaccine. This raised concerns by the scientists and doctors considering the safety and efficacy of the shot.

RDIF and Dr. Reddy’s did not immediately reply to Reuters’ requests for comment outside business hours.

Meanwhile, according to a UK media report, coronavirus vaccine which was developed by the University of Oxford and AstraZeneca could be cleared by health regulators by this year’s end.

The vaccine developed by the University of Oxford and AstraZeneca reached the furthest among all vaccines in clinical trials process. As per a source, NDTV reported, “We are looking at closer to six months and it is likely to be far shorter than that.”

As per a protocol developed by the Joint Committee of UK on Vaccination and Immunisation, any vaccine which is approved will be given to all those with age over 65 years, later given to younger adults who are at higher risk.


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