The Indian embassy in Moscow is in touch with the Russian medical research institute that has developed the world’s first Covid-19 vaccine to be cleared for use by the public, – the statement is given by a top government sources.
Russian Covid-19 vaccine Sputnik V : “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”- the statement is given by a source. Also it has said that, “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”.
Last week, Russian regulators gave a green signal to the Sputnik V vaccine , developed by the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology. President Vladimir Putin announced that one of his daughters had already been inoculated with it.
Putin has claimed that the vaccine works effectively, and forms a stable immunity, against the infection.
The official Sputnik V website, run by the Russian sovereign wealth fund Russian Direct Investment Fund, says phase 1 and 2 clinical trials of the vaccine were completed on august 1,2020, and the vaccine received a registration certificate under “emergency rules” from the Russian Ministry of Health on August 11.
The Sputnik V website , says, ” The high efficacy of the vaccine was confirmed by high precision tests for antibodies in the blood serum of the volunteers, 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 website , also says that on august 12, the start of phase 3 clinical trial involving more than 2,000 people will take place in Russia, a number of Middle Eastern and Latin American countries.
Western experts have been skeptical about the Russian claim, given the speed and secrecy with which the Gamaleya candidate has been given regulatory approval. Developing a vaccine is complex and lengthy process, and the candidates must pass extensive field trials before it is cleared for human use. The Sputnik V candidate has been approved without being put through final phase 3 human trials.
Gamaleya is yet to publish the results of phase 1 and 2 of the clinical trials. In phase 1, the vaccine candidate is given to a small group of people and scientists measure the antibodies it triggers in the recipients. The process takes about three months and if found safe, the trial moves to the next phase.
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 neutralizing antibody 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.
The vaccine is given to several hundred people to assess reactogenicity , immunogenicity and safety. This stage trials has been shortened in the development of Covid-19 vaccines and as many as six candidates are currently in phase 3 of human trials.
A Reuters report quoted Kirill Dmitriev, CEO of RDIF, as saying Russia had received requests for a billion doses of the vaccine from other countries, and that international agreements had been secured to produce 500 million doses annually. Clinical trials were expected to start soon in the UAE and the Philippines, and Rodrigo Duterte, the President of Philippines would participate personally.