India’s drug regulator has granted permission for restricted emergency use of the Russian COVID-19 vaccine Sputnik V with certain conditions, the Union Health Ministry announced on Tuesday, while stating that Dr Reddy’s Laboratories will import the vaccine for use in the country.
The approval by the Drugs Controller General of India (DCGI) paves the way for a third vaccine to be available in the country.
The approval came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Monday recommended granting approval to Sputnik V for restricted emergency use subject to certain regulatory conditions.
The DCGI in January had already given the emergency use authorisation for two COVID-19 vaccines — Covaxin of the Bharat Biotech and Covishield of Oxford-AstraZeneca, being manufactured by the Serum Institute of India in Pune.
Dr Reddy’s Laboratories Ltd (DRL) had applied for the grant of permission to import and market Gam-COVID-Vac combined vector vaccine, popularly called Sputnik-V, developed by M/s Gamaleya Institute, Russia for Emergency Use Authorization, the ministry said in a statement.
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.
DRL 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 Russian phase 3 clinical trial have been published in the Lancet journal.
The firm was permitted to conduct a phase-2/3 clinical trial in the country and it has submitted interim data from the ongoing phase 2/3-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.
The SEC deliberated on various critical areas for consideration including safety, immunogenicity, efficacy data from overseas clinical studies, indication, age group, dosing schedule, precautions, storage, warnings, adverse effects of special interest, risk benefit evaluation, proposed factsheet, PI, SmPCetc.
The approval of the vaccine in Russia along with its conditions/restrictions was also reviewed by the SEC. The SEC noted that the safety and immunogenicity data presented by the firm from the Indian study is comparable with that of the phase 3 clinical trial interim data from Russia, the statement said.
“After detailed deliberation the SEC recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions,” the ministry said.
The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals of aged 18 years and above and should be administered intramuscularly in two doses of 0.5 ml each with interval of 21 days.
The vaccine has to be stored at -18 C. The vaccine comprises two components I and II, which are not interchangeable.
“After careful consideration, the recommendations of the SEC have been accepted by the Drugs Control General (India).DRL will import the vaccine for use in the country,” the ministry said.