A week after Russian President Vladimir Putin announced the world's first Covid-19 vaccine, the Indian embassy in Moscow is now in touch with the medical research institute that developed it. The vaccine is yet to be cleared for the public use.
The vaccine- Sputnik V is developed by the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology.
“The Indian Mission is engaging separately with the Russian side through our embassy in Moscow. We are now awaiting the safety and efficacy data of this vaccine for Covid-19,” a source told Indian Express.
However, the western experts have been sceptical about Russia’s claim, given the speed and secrecy with which the Gamaleya candidate has been given regulatory approval.
The Sputnik V candidate has been approved without being put through final phase 3 human trials, experts added.
The official Sputnik V website, run by the Russian Direct Investment Fund (RDIF), states that the phase 1 and 2 clinical trials of the vaccine were completed on August 1, and the vaccine was given a registration certificate from the Russian Ministry of Health “emergency rules” on August 11.
The website further stated that the phase 3 clinical trials of the vaccine involving more than 2,000 people from Russia, Middle Eastern (UAE and Saudi Arabia), and Latin American countries (Brazil and Mexico), will start on August 12.
President Putin on the vaccine’s development claimed that it works ‘quite effectively’ and ‘forms a stable immunity’ against the infection. He also announced that one of his daughters had already been inoculated with it.
According to the Russian study design published in the clinical trial registry, researchers will assess the adverse events for an average 180 days, and measure the change in antibody levels against the SARS-CoV-2 glycoprotein on days 0, 14, 21, 28, and 42. The researchers will also assess the concentration of the neutralising antibodies on days 0, 14, 28, and 42, and the change in the cellular immunity level, specifically T-cell immunity, on days 0, 14, and 28, reported IE.
“The high efficacy of the vaccine was confirmed by high precision tests for antibodies in the blood serum of volunteers (including analysis for antibodies that neutralize the coronavirus), as well as the ability of the immune cells of the volunteers to activate in response to the spike S protein of the coronavirus, which indicates the formation of both antibody and cellular immune vaccine response,” the Sputnik V website states.