AfterCovishield and Covaxin, India on Tuesday granted permission to inject the thirdCovid-19 vaccine 'Gam-COVID-Vac' combined vector vaccine, popularly calledSputnik-V, in emergency situations.
TheDrugs Controller General India (DCGI) gave its nod for the emergency use of thevaccine based on recommendations of the the Subject Expert Committee (SEC) andcareful consideration, Ministry of Health and Family Welfare (MoHF) said onTuesday.
"Afterdetailed deliberation the SEC recommended for grant of permission forrestricted use of Sputnik-V in emergency situations subject to variousregulatory provisions," the MoHF said.
Thevaccine is indicated for active immunisation to prevent Covid-19 disease inindividuals of 18 years and above, said the Ministry, adding "the vaccineshould be administered intramuscularly in two doses of 0.5 ml each withinterval of 21 days.
"Thevaccine has to be stored at -18 degrees Celsius. The vaccine comprises of two componentsI & II, which are not interchangeable."
TheMinistry said that the recommendations of the SEC have been accepted by theDrugs Controller General (India) after careful consideration, and that"Dr. Reddy's Laboratories Ltd. (DRL) will import the vaccine for use inthe country".
Thecountrywide vaccination drive started from January 16. Two vaccines have beenapproved for Emergency Use Authorisation (EUA) by the National Regulator--Drugs Controller General of India (DCGI). These are "Covishield" manufacturedby Serum Institute of India (SII) and "Covaxin" manufactured byBharat Biotech International Limited (BBIL).
DRLhad applied for the grant of permission to import and market Gam-COVID-Vac,developed by Gamaleya Institute, Russia for Emergency Use Authorisation. TheGam-COVID-Vac combined vector vaccine (Component I and Component II) has beendeveloped by National Research Centre for Epidemiology and Microbiology of theMinistry of Health of the Russian Federation, Moscow, Russia and is approved in30 countries across the world.
DRLhas collaborated with National Research Centre for Epidemiology andMicrobiology of the Ministry of Health of the Russian Federation for obtainingregulatory approval for import for marketing in India. The interim results ofSafety immunogenicity and efficacy from Russian Phase III clinical trial havebeen published in the journal Lancet.
"DRLwas permitted to conduct a Phase-II and III clinical trial in the country. Thefirm has submitted interim data from the ongoing Phase-II and III clinicaltrial in the country.
"Thedata from the clinical trial is being continuously assessed by the CDSCO inconsultation with the Subject Expert Committee (SEC) as a rapid regulatoryresponse. The SEC consists of domain knowledge experts from the fields ofpulmonology, immunology, microbiology, pharmacology, paediatrics, internalmedicine," the Ministry said.
"TheSEC deliberated on various critical areas for consideration including safety,immunogenicity, efficacy data from overseas clinical studies, indication, agegroup, dosing schedule, precautions, storage, warnings, adverse effects ofspecial interest, risk benefit evaluation, proposed factsheet, PI, SmPCetc," it said.
Theapproval of the vaccine in Russia along with its conditions and restrictionswas also reviewed by the SEC, said the Ministry, adding the SEC noted that thesafety and immunogenicity data presented by the firm from the Indian study iscomparable with that of the Phase III clinical trial interim data from Russia.
Further,the Ministry noted that the Central government has been leading the fightagainst Covid-19 with a proactive and "whole of government" approach,with focus on containment, surveillance, testing, Covid appropriate behaviourand vaccination.
"Severalother vaccines are at various stages of clinical development within thecountry."