Russian Vaccine Sputnik V may be Approved in EU
Named after the first Soviet space satellite, Russia’s Sputnik V vaccine has a 91.6% success rate, according to independent international medical journal The Lancet.
Hungary was the first EU country to grant emergency approval of Russia’s Sputnik V coronavirus vaccine. German Chancellor Angela Merkel has stated that she is ready to support Russia in her request for authorization from the European regulators. Sputnik V is already registered in 17 countries. Requests for the vaccination for more than 1.2 billion people (2.4 billion doses as it is a two-doze vaccine) have already been made.
Sputnik V’s 91.6% success rate is based on the analysis of data from 19,866 volunteers, who received both the first and second doses of either the vaccine or a placebo. Phase 1 and 2 clinical trials of the vaccine were completed on 1 August 2020.
“All the volunteers are feeling well and no unforeseen or unwanted side effects were observed,” states the Sputnik V website. “Not a single participant of the current clinical trials got infected with Covid-19 after being administered with the vaccine.”
The high efficacy of the vaccine was confirmed by high precision tests for antibodies in the volunteers. The volunteers’ cells were able to activate in response to the spike S protein of the coronavirus, which indicates the formation of antibodies.
Phase 3 interim results
Post-registration clinical trials involving more than 31,000 people in Russia and Belarus were launched on 25 August 2020. A number of countries, such as UAE, India and Venezuela joined the clinical trials of Sputnik V locally. The vaccine received a registration certificate from the Russian Ministry of Health on 11 August.
In Phase III clinical trials, Sputnik V showed strong efficacy, immunogenicity and safety results, which were recently published by the Lancet medical journal.
“The trial results show a consistent strong protective effect across all participant age groups…including those older than 60 years,” stated the Lancet medical journal on 2 February 2021.
Under emergency rules adopted during the Covid-19 pandemic, Sputnik V can now be used to vaccinate the population in Russia.
The vaccine’s positive results, published by an independent international medical journal, demonstrate that Sputnik V can now join the fight against Covid-19.