New Delhi (NVI): India has got its third coronavirus vaccine as National Regulator DCGI (Drugs Controller General of India) today granted permission to Russian Covid vaccine Sputnik-V for restricted use in emergency cases. Hyderabad-based Dr Reddy’s Laboratories (DRL) has been given the permission to import the vaccine.
This comes a day after the Subject Expect Committee (SEC) gave its nod to the vaccine as India battles a second wave of the coronavirus pandemic with a record number of daily cases being reported for the past few days.
The vaccine is indicated for active immunisation to prevent COVID-19 disease in individuals over 18 years of age, according to the Health Ministry.
“M/s 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 called Sputnik-V, developed by M/s Gamaleya Institute, Russia for Emergency Use Authorization,” the Ministry of Health said in a statement.
The Ministry further said that Sputnik-V vaccine (Component I & Component II) has been developed by 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.
It said that Dr Reddy’s Laboratories (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 Health Ministry said that Dr Reddy’s Laboratories 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, it said.
The approval of the vaccine in Russia along with its conditions/restrictions was also reviewed by the SEC. The SEC noted that the safety & immunogenicity data presented by the firm from the Indian study is comparable with that of the Phase III clinical trial interim data from Russia, as per the Health Ministry.
After detailed deliberation, the SEC recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions, it said.
The vaccine should be administered intramuscularly in two doses of 0.5 ml each with interval of 21 days. (Day 0: Component I & Day 21: Component II), the Ministry said giving details.
Apart from that, the vaccine has to be stored at -18°C. It comprises of two components I & II, which are not interchangeable.
The countrywide vaccination drive started from January 16. Two vaccines have been approved for Emergency Use Authorisation (EUA) by (DCGI)– “Covishield” manufactured by Serum Institute of India (SII) and “Covaxin” manufactured by Bharat Biotech International Limited (BBIL). Several other vaccines are at various stages of clinical development within the country, the Health Ministry said.