India may grant EUA for Sputnik V this month

India may grant emergency use authorisation to another coronavirus vaccine — Russia’s Sputnik V — this month or next, reported news agency ANI. “India is a key partner in terms of production of vaccine and we expect that there’ll be a restricted emergency use order for the Sputnik V vaccine…this month or next. After that we will be able to start our vaccine delivery to India,” Kirill Dmitriev, Russian Direct Investment Fund chief said.

Russia’s experimental coronavirus vaccine Sputnik V is 91.6% effective against in protecting people from COVID-19, according to results published in The Lancet on Tuesday. The new results are based on data from 20,000 participants in the phase III trial.

“The data published by The Lancet shows that Sputnik V is one of only three vaccines in the world with the efficacy of over 90 per cent but outperforms them in terms of safety, ease of transportation due to storage requirements of 2 to 8 degrees, and a more affordable price. Sputnik V is a vaccine for all mankind,” Dmitriev said.

Russia was the first country in the world to register a COVID-19 vaccine in August. The vaccine has been developed by Gamaleya Research Institute and the Russian defence ministry.

“The Russian vaccine is based on a well-researched human adenoviral vector platform which has proven to be safe, with no long-term adverse effects in more than 250 clinical trials over decades,” said Dmitriev.

The uniqueness of the Russian vaccine lies in the use of two different human adenoviral vectors as a delivery mechanism of the outer coat genetic material of coronavirus to human body, the researchers said. “This approach provides for creation of a stronger and long-term immunity as compared to vaccines, using one and the same component for both doses,” they added.

“The level of virus neutralizing antibodies of volunteers vaccinated with Sputnik V is 1.3-1.5 times higher than the level of antibodies of patients who recovered from COVID-19,” according to The Lancet.

Dr Reddy’s has partnered with the RDIF to conduct the clinical trials of the Sputnik V vaccine and its distribution rights in India. It had last month received approval from the Drugs Control General of India (DCGI) to conduct phase III clinical trial for the Sputnik V vaccine for COVID-19.

“Sputnik V is already registered in 16 countries including Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia and Armenia,” according to The Lancet’s paper. Sputnik V is considered as one of the most affordable vaccines in the world with a price of less than $10 per shot. – Mint