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Sputnik V: India Declines Permission to Test Russia’s COVID-19 Vaccine on Large Scale

The drug regulator noted that the safety and immunogenicity data from early-stage studies were being conducted overseas in small batches, and there are no inputs available on Indian participants.

Coronavirus Vaccine Latest Update: In a major setback on the coronavirus vaccine front, the Drugs Controller General of India (DCGI) on Thursday refused the proposal of pharma major dr Reddy’s Laboratories Ltd to conduct large scale study of Russia’s Sputnik-V for COVID-19 treatment and asked it to conduct clinical trials in smaller batches first.

The drug regulator noted that the safety and immunogenicity data from early-stage studies were being conducted overseas in small batches, and there are no inputs available on Indian participants.

The trials of Sputnik V are mired in controversy. The Russian government has registered Sputnik V as a COVID-19 vaccine without even conducting full clinical trials. Besides, the phase I and II of the trials involved merely 76 participants.

However, with some countries facing inconsistencies during the clinical trials of Sputnik-V. The Indian scientists and medical experts are also of the opinion that the Indian government should conduct phase-2 trials of the vaccine to prove its safety and efficacy.

After much hue and cry over the Russian vaccine, Union Health Minister Harsh Vardhan clarified this month that the government was yet to take a final decision on phase-3 trials of Sputnik V.

Last month, Dr Reddy’s announced that the final stage clinical trials of Sputnik V could begin in India in the next few weeks.

Russia had announced in August that it has developed the world’s first coronavirus vaccine. In fact, a study published in The Lancet declared the vaccine as “Safe, well-tolerated, and does not cause serious adverse events in healthy adult volunteers.”

Sputnik V, an adenovirus vector-based vaccine, was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, along with the Russian Direct Investment Fund and registered on August 11.

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