Russia’s Sputnik V vaccine: Dr Reddy’s starts process for emergency use approval in India – Mint

Pharma company Dr Reddy’s Laboratories on Friday said it has sought emergency use authorization for Russia’s Sputnik V COVID-19 vaccine in India.

“Dr. Reddy’s today announced that it has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V,” the company said in a regulatory filing.

As part of the review process, Dr Reddy’s will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 21 February 2021, it further stated.

On Friday, Dr Reddy’s scrip on BSE was trading 1.51% higher in late trade at 4,687.75 apiece.

Small human trials of the Russian vaccine have been ongoing in India, conducted by Dr Reddy’s Laboratories Ltd and supported by the Russian Direct Investment Fund (RDIF). Earlier this month, Russian news agency RIA cited India’s ambassador to Moscow as saying that the country could Sputnik V vaccine within the next few weeks.

In September 2020, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India.

The vaccine is currently undergoing the phase 3 clinical trial in India. Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia, who received both the first and second doses of the vaccine. Sputnik V maintained a consistent efficacy at 91.8% even among the group of 2, 144 volunteers over 60 years old.

G V Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories said, “The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India.”

Dr Reddy’s will supply around 250 million doses of the Sputnik vaccine, while Hetero Biopharma, which also has an agreement with RDIF, will manufacture about 100 million doses per year.

Sputnik V covid vaccine is developed by the Gamaleya National Research Institute of Epidemiology and Microbiology and was registered by the Ministry of Health of Russia on 11th August 2020. It was also touted as the world’s first registered vaccine candidate against COVID-19 based on the human adenoviral vector platform.

Unlike the Pfizer/BioNTech vaccine, Sputnik V can be stored in a fridge rather than a freezer, making it easier to transport and distribute in poorer and hotter countries. At around $20 for a two-shot vaccination, it’s also cheaper than most Western alternatives.

More than 250 clinical studies over two decades have proven the safety, efficacy, and lack of negative long-term effects of adenoviral vaccines. Sputnik V has been granted authorizations in 26 countries globally. The vaccine has already been administered to more than 2 million people worldwide, the company stated.

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