New Delhi: The National Regulator has granted permission to use Sputnik-V for restricted use in emergency situations.
Dr Reddy’s Laboratories Ltd. (M/s DRL) had applied for the grant of permission to import and market Gam-COVID-Vac combined vector vaccine, popularly known as Sputnik-V, developed by Gamaleya Institute, Russia for Emergency Use Authorization.
The Gam-COVID-Vac combined vector vaccine (Component I & Component II) has been developed by the National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation, Moscow, Russia and is approved in 30 countries across the world.
Dr Reddy’s Lab has collaborated with the National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation for obtaining regulatory approval for import for marketing in India. The interim results of Safety immunogenicity and efficacy from the Russian Phase III clinical trial have been published in Lancet journal.
Dr. Reddy’s Lab was permitted to conduct a Phase-II/III clinical trial in the country. The firm has submitted interim data from the ongoing Phase-II/III clinical trial in the country. The data from the clinical trial is being continuously assessed by the CDSCO in consultation with the Subject Expert Committee (SEC) as a rapid regulatory response. The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.
Use of Sputnik-V vaccine
The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals ≥ 18 years of age. The vaccine should be administered intramuscularly in two doses of 0.5 ml each with an interval of 21 days. (Day 0: Component I & Day 21: Component II). The vaccine has to be stored at -18°C. The vaccine comprises of two components I & II, which are not interchangeable. After careful consideration, the recommendations of the SEC have been accepted by the Drugs Control General (India). M/s DRL will import the vaccine for use in the country.
