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The Russian Direct Investment Fund (RDIF) started conducting clinical trial in September 2020 in India, and finally sought the government's approval for the vaccine. After Covishield and Covaxin, this will be India's third Covid-19 vaccine 'Gam-Covid-Vac' combined with vector vaccine, otherwise known as Sputnik-V. The Russian-based vaccine has been approved for emergency purposes.
As per the Ministry of Health and Family Welfare (MoHF), the Drugs Controller General India (DCGI) gave its nod for the emergency use of the vaccine based on recommendations of the Subject Expert Committee (SEC) and careful consideration. "After detailed deliberation the SEC recommended for grant of permission for restricted use of Sputnik-V in emergency situations subject to various regulatory provisions," the MoHF said.
Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, became the world's first registered vaccine against Covid-19. The vaccine is an adenovirus-based vaccine that is being used in Moscow to inoculate the masses.
Sputnik-V is a combination of two different adenoviruses (viruses that causes common cold), combined with SARS-CoV-2, the virus that causes Covid-19, spike protein. According to a study published in the peer-reviewed medical journal The BMJ, this combination allows the body to make an immune response against the vector and destroy it when the second dose is injected.
As per the Health Ministry, the vaccine will be available for active immunization in individuals of 18 years and above. "The vaccine should be administered intramuscularly in two doses of 0.5 ml each with interval of 21 days. It must be stored at -18 degrees Celsius. The vaccine comprises of two components I & II, which are not interchangeable," said the Ministry.
After the I and II trial of the coronavirus vaccine, a study in BMJ reported that all participants in these trial showed SARS-CoV-2 showed antibodies and that no serious adverse effects were detected. In the interim results of the phase 3 trial, Sputnik-V showed an efficacy rate of 91.6 per cent. The third trial of the vaccine included 19,866 volunteers in Russia, who received both the first and second dose of the vaccine.
Following the approval by the Drugs Controller General (India), Dr. Reddy's Laboratories Ltd. (DRL) will import the vaccine for use in the country.
Despite the authorities clearing the vaccine, there is no still no decision on the price at which the vaccine will be procured by the government. Prices are yet to be concluded with the Russian Direct Investment Fund (RDIF). Reports suggest that Sputnik might not be able to match the price of AstraZeneca's Covishield vaccine. Currently, the Sputnik V vaccine is being cold at approximately 10 dollars a dose in most countries. So far, the pricing has been the same for every country where Sputnik is being marketed.
(with inputs from IANS)