Russian anti-COVID vaccine Sputnik V tested with 100 Indian volunteers

Sputnik V is a human adenovirus vector vaccine against COVID, Russian researchers say (representative)

Moscow:

The Russian Sputnik V vaccine against COVID-19 will be tested in India with 100 volunteers, the Drug Controller General (DCGI) of the Central Pharmaceutical Standards Authority of India told Russian news agency Sputnik on Thursday.

DCGI has allowed pharmaceutical giant Dr Reddy’s Laboratories to perform the test. However, the date and time of the exam will be decided by the company.

News agency Sputnik quoted the organization as saying that the vaccine would be tested in the second phase of clinical trials before proceeding to Phase 3.

Last week, a DCGI expert committee recommended that Dr. Reddies Laboratories be granted permission to conduct a Phase 2 clinical trial of Russian COVID-19 vaccine candidate Sputnik V in India.

According to government officials, Dr Reddy’s Lab said in a Phase 2 clinical trial that “100 subjects will be included and Phase 3 will require 1,400 subjects.”

“Once a pharmaceutical company submits Phase 2 safety and immunogenicity data, it can be analyzed by a panel of experts and proceed to Phase 3 trials,” officials added.

On October 13, news agency ANI reapplied a new protocol to DCGI by Dr. Reddy’s Laboratories to seek approval to conduct Phase 2 and Phase 3 clinical trials of the Russian COVID-19 vaccine. I reported.

Please note that on October 5th, the Area Expert Committee (SEC) conducted a thorough evaluation of previous applications submitted by Dr. Reddy’s Lab. The SEC then instructed pharmaceutical companies to apply for a revised protocol with more information.

An Indian pharmaceutical company is working with the Russian Foreign Direct Investment Fund (RDIF) to conduct clinical trials and distribution of the Sputnik V vaccine.

According to RDIF, Indian pharmaceutical company Dr Reddy’s Lab will be supplied with 100 million doses of COVID-19 vaccine.

Last month, RDIF CEO Kirill Dmitriev announced that Russia is in close dialogue with the Government of India and Indian pharmaceutical companies regarding the localization of Sputnik V vaccine production in India.

In addition, the leading medical journal, The Lancet, published the results of Phase I-II clinical trials of Russian vaccines, demonstrating its safety and efficacy.

On August 11, the Sputnik V vaccine candidate, jointly developed by RDIF and the Gamareya National Center for Epidemiological Microbiology, was registered by the Russian Ministry of Health and became the world’s first registered vaccine against COVID-19.

According to Russian researchers, Sputnik V is a human adenovirus vector vaccine that fights coronavirus disease.

(Except for the headline, this story has not been edited by NDTV staff and is published from the Syndicate Feed.)

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