New Delhi: Drugs Controller General of India (DCGI) is allowed to operate Phase III bridging tests NS sputnik light on Indian population. NS Artificial satellite Light Russian Vaccine is Sputnik’s single-dose COVID-19 vaccine.
The approval comes after a recent study published in the medical journal The Lancet noted that Sputnik Lite showed 78.6 to 83.7 percent efficacy against COVID-19, significantly higher than most two-shot vaccines. Is.
In July, the subject expert committee of the Central Drugs Standard Control Organization (CDSCO) refused emergency-use authorization to Sputnik-Lite, rejecting the need for Phase III trials of the Russian vaccine in the country.
The committee noted that Sputnik Lite was similar to component-1 of Sputnik V and that its safety and immunogenicity data had already been generated in a trial in the Indian population.
The study was conducted on at least 40,000 elderly people in Argentina. The study noted that Sputnik Lite reduced the number of hospitalizations among the target population by 82.1-87.6 percent.
The Russian Direct Investment Fund (RDIF) had partnered with Dr Reddy’s Laboratories for the Phase III trial of the Sputnik V vaccine in India last year. In April, Sputnik V received an emergency use authorization in India. Reddy’s delivered the first dose of the vaccine in Hyderabad on 14 May in a limited pilot.
The approval comes after a recent study published in the medical journal The Lancet noted that Sputnik Lite showed 78.6 to 83.7 percent efficacy against COVID-19, significantly higher than most two-shot vaccines. Is.
In July, the subject expert committee of the Central Drugs Standard Control Organization (CDSCO) refused emergency-use authorization to Sputnik-Lite, rejecting the need for Phase III trials of the Russian vaccine in the country.
The committee noted that Sputnik Lite was similar to component-1 of Sputnik V and that its safety and immunogenicity data had already been generated in a trial in the Indian population.
The study was conducted on at least 40,000 elderly people in Argentina. The study noted that Sputnik Lite reduced the number of hospitalizations among the target population by 82.1-87.6 percent.
The Russian Direct Investment Fund (RDIF) had partnered with Dr Reddy’s Laboratories for the Phase III trial of the Sputnik V vaccine in India last year. In April, Sputnik V received an emergency use authorization in India. Reddy’s delivered the first dose of the vaccine in Hyderabad on 14 May in a limited pilot.
.