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Russian vaccine ‘Sputnik V’-India denies the claim-Bharat Biotech
Updated: Dec 1, 2020
By M. Palani Selvi, B.Sc.,
A New Coronavirus, SARS-CoV 2 is an infectious disease, which has spread to nearly every country. The World Health Organization declared it as a Pandemic. More than 100 vaccines are being worked across the world. Among those six vaccines reached phase 3 clinical trials.
Russia has promised to develop the world’s first novel coronavirus vaccine. The Gamaleya research institute of Epidemiology and Microbiology, a state research facility in Moscow, Russia engaged in the process of developing Vaccine for COVID 19 and completed early human trials in July month. The research institute is working in coordination with the country’s defence ministry. Kirill Dmitriev, head of Russia’s Sovereign wealth fund, says, “It is a Sputnik moment”, by referring to the launch of the world's first satellite, Sputnik in 1957.
On August 11, Russian President Vladimir Putin announced that Russia has approved the vaccine ‘Sputnik V’, developed by Gamaleya institute against the corona virus. One of the daughters of the President has been vaccinated. But the scientists and experts in some countries are sceptical because the vaccine has been approved without large scale phase 3 human trials. Kirill said, phase 3 trials would be started and they have planned to start the industrial production around September. It is said by Russia that, twenty countries showed interest in obtaining the Sputnik V vaccine from them.Immediate global demand for the vaccine is of billions of doses. But, in a year Russia can produce only 1.5 million doses of vaccine. Thus, international agreements have been signed to produce 500 million doses.
Deployment issues in India:
The Union Health Ministry of India denied Moscow’s claim. Usually, The Indian Regulatory System will approve the vaccine or drugs developed by foreign countries only after conducting the human trials in the local population. Which means, phase 2 and phase 3 trials have to be conducted on Indian volunteers. This process would take at least two to three months. The other way of issuing vaccines is, the drug regulatory authorities of India can issue an emergency authorization to the Russian vaccine ‘Sputnik V’. If the emergency authorization is issued, there is no need for phase trials. This has been done in the case of Remdesivir drug. But the thing is, the drug will be given only to the patients with the consideration of doctors. But the vaccine is supposed to be injected to the public. So, using a vaccine without the phase trials in such a large number is very risky. Russia had not yet released the proper vaccine trial data conducted in the second half of June for the examination. A doubt about the safety has been raised even by the Moscow based drug manufacturing company, ACTO (Association of Clinical Trials Organization).
Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) – National Institute of Virology has developed an Indigenous vaccine named COVAXIN. It has completed its first trial. The process for phase 2 and phase 3 trial is going on simultaneously. Proper data of trial is recorded, unlike Sputnik V. This gave them the confidence in India to deny the Sputnik V vaccine, despite the increase in the number of coronavirus cases.