Amid reports of shortage of COVID-19 vaccine in the country, the Drugs Controller General of India (DCGI) has approved restricted emergency use of Russian COVID-19 vaccine Sputnik V in India, the Union Health Ministry announced on Tuesday.
The approval for Sputnik V by the country’s drugs controller came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Monday recommended approval to the Russian vaccine for restricted emergency use subject to certain regulatory conditions.
Sputnik V is the world’s first registered COVID-19 vaccine developed by the 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.
The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals above 18 years of age. 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 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).
Dr Reddy's Laboratories (DRL) will import the vaccine, the third in the country, after Covaxin and Covishield, the Union Health Ministry said in a statement. It stated that DRL had applied for the grant of permission to import and market Sputnik-V - Gam-COVID-Vac combined vector vaccine for Emergency Use Authorization. The interim results of Safety immunogenicity and efficacy from Russian Phase III clinical trial have been published in Lancet journal.
Currently two vaccines -- Covaxin manufactured by Bharat Biotech International Ltd (BBIL) and Covishield by Serum Institute of India (SII), have received Emergency Use Authorization (EUA) from the DCGI.
The ministry stated that 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 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 III clinical trial interim data from Russia.
After detailed deliberation, the SEC recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions.
The ministry also stated that the matter of augmenting the Basket of Vaccines available for fighting the pandemic as well as to accelerate the pace and coverage of domestic vaccination programme was discussed in the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) on April 11, 2021, chaired by Dr V K Paul, Member (Health), Niti Aayog.
NEGVAC, after comprehensive deliberation, recommended that vaccines for COVID-19, which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO (Emergency Use Listing) may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019, the ministry stated.
The first 100 beneficiaries of such foreign vaccines will be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country.
The Union Government, after due consideration, accepted the recommendation of NEGVAC, the ministry stated.
The decision is expected to facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic use, the ministry added.
The countrywide vaccination drive in India started from Januanry 16, 2021.
