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Dr Reddy Applies to DCGI for Sputnik V Candidate Vaccine Approval – The Wire Science



A nurse prepares Russia’s Sputnik V vaccine against COVID-19 for inoculation at a clinic in Tver, Russia. Photo: Reuters

Hyderabad-based pharmaceutical firm Dr Reddy’s has initiated the process of obtaining an ‘accelerated approval’ for Russia’s Sputnik V COVID-19 vaccine candidate, with the Drug Controller General of India (DCGI). They had partnered with the Russian Direct Investment Fund (RDIF) in September 2020 to conduct clinical trials for Sputnik V.

Dr Reddy’s Laboratories has been testing the vaccine candidate’s safety and efficacy in the Indian population through phase 2/3 clinical trials, with around 1,500 participants in the country.

Interim results of the ongoing phase 3 trials published in The Lancet showed an efficacy rate of 91.6% and included data on 19,866 volunteers in Russia, who had received both the first and second doses of the vaccine candidate.

As part of the review process, Dr. Reddy’s will present the safety profile from the phase 2 study and interim data from the phase 3 study in the Indian population by February 21.

Gamaleya National Research Institute of Epidemiology and Microbiology developed Sputnik V and named it after the first Soviet space satellite. Russia’s Ministry of Health registered the vaccine on August 11, 2020. It became the world’s first registered vaccine candidate against COVID-19, based on the human adenoviral vector platform.

David Livermore, a professor of medical microbiology at the University of East Anglia, UK, issued a statement about Sputnik V’s interim results in The Lancet, saying, “Presently the world needs all the good vaccines that it can against COVID-19. And these are impressive results:Sputnik V is the first adenovirus vector vaccine to achieve the 90% efficacy seen with the two mRNA vaccines.”

Sputnik V is one of only three vaccine candidates in the world with an efficacy of 91.6% and is authorised for use in 26 countries. More than two million people across the globe have already received the vaccine.

Sputnik V’s efficacy is lower than that of vaccine candidates developed by Pfizer-BioNTech and Moderna, which have efficacies of around 95% and 94%. However, it has a higher reported efficacy than vaccines candidates currently in use in India, Covaxin and Covishield.

A subject expert committee of the Central Drug Standards Control Organisation, which is helmed by the DCGI, will now study Dr. Reddy’s application and will accordingly recommend a suitable course of action. If approved by the DCGI, Sputnik V will become the third vaccine candidate to receive ‘accelerated approval’ approval in the country.



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