India gets third coronavirus vaccine as DCGI approves Russia's Sputnik V

DY365
DY365
Published: April 13,2021 02:15 PM
DY365

Story highlights

India's drug regulator, the Drugs Controller General of India (DCGI) on Tuesday approved Russian Covid-19 vaccine Sputnik V for 'restricted use in emergency situations' in India.

April 13, 2021: India's drug regulator, the Drugs Controller General of India (DCGI) on Tuesday approved Russian Covid-19 vaccine Sputnik V for 'restricted use in emergency situations' in India. This was a day after the Subject Expert Committee (SEC) gave its thumbs up to the vaccine. Hyderabad-based Dr Reddy's Laboratories (DRL) has collaborated with the Russian health ministry to obtain regulatory approval for import of the vaccine in India.



The health ministry said in an official statement: "After detailed deliberation, the SEC recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions. DRL has collaborated with 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 vaccine is indicated for active immunisation to prevent Covid-19 in individuals over18 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), and it has to be stored at minus 18 degrees Celcius. It comprises two components I & II, which are not interchangeable.



"After careful consideration, the recommendations of the SEC have been accepted by the DCGI. DRL will import the vaccine for use in the country," the Union health ministry said.



Two vaccines were earlier approved for emergency-use authorisation (EUA) by the regulator. These are Covishield, manufactured by Serum Institute of India (SII), and Covaxin, manufactured by Bharat Biotech International Limited (BBIL). Several other vaccines were at various stages of clinical development within the country, the health ministry said.



"Dr Reddy’s Laboratories Ltd had applied for the grant of permission to import and market Gam-Covid-Vac combined vector vaccine, popularly called Sputnik-V, developed by Gamaleya Institute, Russia for Emergency Use Authorisation," the statement said.



The Gam-Covid-Vac combined vector vaccine (Component I & 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, according to the statement.



The interim results of safety immunogenicity and efficacy from Russian Phase-III clinical trial have been published in Lancet journal.



DRL 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. "The data from the clinical trial is being continuously assessed by the Central Drugs Standard Control Organisation (CDSCO) in consultation with the 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 government said.



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 was comparable with that of the Phase-III clinical trial interim data from Russia.



After detailed deliberation, the SEC recommended grant of permission for restricted use in emergency situations subject to various regulatory provisions.