Russia claims Sputnik V vaccine 92% effective on Coronavirus
Hyderabad/New Delhi: Sputnik V vaccine for COVID-19, which is being developed by Russia's Gamaleya National Research Institute of Epidemiology and Microbiology, has demonstrated an efficacy rate of 92 per cent.
The confirmation is based on the first interim data from the largest randomised, placebo-controlled Phase-III clinical trials in Russia involving 40,000 volunteers, a press release from Gamaleya and the Russian Direct Investment Fund (RDIF) said.
The trials evaluated the efficacy among over 16,000 volunteers who received the vaccine or placebo 21 days after the first injection.
As a result of a statistical analysis of 20 confirmed cases of coronavirus, the case split between vaccinated individuals and those who received the placebo indicating that the Sputnik V vaccine had an efficacy rate of 92 per cent after the second dose, the release said.
In September 2020, Dr Reddys and Russian Direct Investment Fund (RDIF), Russias sovereign wealth fund,entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India.
As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr Reddys upon regulatory approval in India.
On August 11, 2020, the Sputnik V vaccine was registered by the Ministry of Health of Russia and became the worlds first registered vaccine against COVID-19 based on the human adenoviral vectors platform.
As of November 11, as part of the clinical trials in Russia's 29 medical centres, more than 20,000 volunteers were vaccinated with the first dose and over 16,000 volunteers with the first and the second dose of the vaccine. In addition, as on the date, no unexpected adverse events were identified as part of the research.
Some of those vaccinated had short-term minor adverse effects such as pain at the injection site, flu-like syndrome, including fever, weakness, fatigue, and headache, according to the release.
Alexander Gintsburg, director of Gamaleya Centre, said the publication of the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccines efficacy gives way to mass vaccination in Russia against COVID-19 in the coming weeks."
Earlier on Monday, Pfizer Inc and BioNTech SE said their vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19.
Meanwhile, AIIMS Director Dr Randeep Guleria said on Wednesday that the extreme low temperature of minus 70 degrees Celsius required for storing a potential COVID-19 vaccine developed by Pfizer poses a big challenge for its delivery in a developing nation like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult.
Most vaccines in India need to be stored at a temperature of two to eight degrees Celsius. The lowest minimum temperature at which vaccines can be kept to maintain the cold chain in most areas in the country is minus 25 degrees Celsius, Guleria said.
He, however, said the first set of results announced by Pfizer Inc. and BioNTech SE from the Phase 3 vaccine trial, showing a 90-per cent efficacy in preventing the coronavirus infection, is quite encouraging.
He stressed that the data released by the firms developing vaccines has to be studied and it has to be seen how long the immunity would last.