Written By: Satata Karmakar | Published : February 3, 2021 9:46 AM IST
Russia's Sputnik V vaccine against novel coronavirus has shown 91.6 per cent efficacy in the phase 3 trial without any serious side effects. The study of the efficiency was published in The Lancet journal on Tuesday.
"Our interim analysis of the randomized, controlled, phase 3 trial of Gam-COVID-Vac in Russia has shown high efficacy, immunogenicity, and a good tolerability profile in participants aged 18 years or older," said study co-lead author Inna V Dolzhikova, from Gamaleya National Research Centre for Epidemiology and Microbiology, Russia.
The author further added that Sputnik V provided full protection against severe cases of Covid-19.
The data published by Lancet was based on a study which was collected from nearly 20,000 participants, three-quarters of whom received the two-dose regimen of the adenovirus-based vaccine, Gam-COVID-Vac, and one quarter received a placebo.
Speaking to the media, the researchers stated that serious adverse events or those requiring hospital admission were rare in both the placebo and vaccine groups, and none were considered associated with vaccination.
"Four deaths were reported in the trial, none of which were considered related to the vaccine," one of the researchers was quoted as saying. He further added, "Most reported adverse events were mild, including flu-like symptoms, pain at the injection site and weakness or low energy".
Speaking about the vaccine and how it helps the Covid-19 patients, the researchers said that the Gam-COVID-Vac, called Sputnik V, is a two-part vaccine that includes two adenovirus vectors recombinant human adenovirus type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S).
Registered by Russia on August 11, 2020, Sputnik V became the world's first coronavirus vaccine.
The vaccine was developed by the Gamaleya National Research Center of Epidemiology and Microbiology.
"The publication of internationally peer-reviewed data on Sputnik V's clinical trial results is a great success in the global battle against the Covid-19 pandemic," Alexander Gintsburg, Director of the Gamaleya Research Institute of Epidemiology and Microbiology, said in a statement.
"Several vaccines have already been created based on human adenoviruses and this tool is one of the most promising for the development of new vaccines in the future," Gintsburg said.
The data in the new study showed 70 episodes of serious adverse events not related to Covid-19 in 68 study participants -- in 45 volunteers from the vaccine group and 23 volunteers from the placebo group.
None of these events were associated with the vaccination, as stated by an independent data monitoring committee.
According to the reports, Dr Reddy's Laboratories Ltd hopes to launch the Russian COVID-19 vaccine Sputnik V in India in March after obtaining Emergency Use Authorisation (EUA).
"About 70 per cent of the trials have already been completed. We hope to roll out the product in March." Dr Reddy was quoted as saying.
How much will Sputnik V vaccine cost you? Well, the price of the vaccine then you must know that the pricing of vaccine has not been decided yet.
Sputnik V is already registered in several countries including Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Venezuela, Paraguay, Turkmenistan, Hungary, the UAE, Iran, Republic of Guinea,Tunisia, and Armenia said the makers of the vaccine
In the first week of February, vaccination with Sputnik V is starting in several countries including Bolivia, Kazakhstan, Armenia, Algeria, Venezuela, and Iran.
The two-dose regimen of Sputnik V is administered 21 days apart.
