New Delhi: The Modi government’s expert panel is likely to meet this week to consider granting emergency approval to Russia’s Covid-19 vaccine Sputnik V, ThePrint has learnt.
Drugmaker Dr. Reddy’s — the company which had entered into a partnership with Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V — last week submitted the immunogenicity data the subject expert committee (SEC) had asked in the first meeting held on 24 February.
The SEC advises the apex regulator Drug Controller General of India (DCGI) on applications seeking approvals for new drugs, vaccines, and clinical trials for Covid-19.
“The company has submitted the data which was asked by the panel. The SEC will meet this week to consider the application for emergency use approval,” a senior official at the Central Drugs Standard Control Organisation’s (CDSCO) told ThePrint.
CDSCO is the health ministry arm that regulates the quality of drugs and vaccines in the country which is headed by DCGI.
The Sputnik V vaccine — which is being developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation, in collaboration with the RDIF, the country’s sovereign wealth fund — has been put through phase 3 clinical trials in India by Hyderabad-based drug maker, Dr. Reddy’s.
India, which rolled out its national vaccination programme on 16 January, has deployed two vaccines — the home-grown Covaxin developed by Bharat Biotech and Oxford-AstraZeneca’s Covishield being manufactured by Serum Institute of India (SII).
Both vaccines had received “conditional approval” from the DCGI on 3 January.
Also read: Strict follow-up, informed consent from recipients — conditions set for cleared Covid vaccines
Data on Sputnik gives hope
According to the results of the phase 3 study published in The Lancet, the trial involved 21,977 people who were assigned to either the vaccine or the placebo groups.
The randomised, double-blind, placebo-controlled trial included those who were 18 years or older and had tested negative on HIV, Hepatitis B and C, syphilis, and SARS-CoV-2 PCR tests with no prior history of Covid-19.
Around 19,688 of the total participants “received two doses of vaccine or placebo and were included in the primary outcome analysis”.
“From 21 days after the first dose of vaccine (the day of dose 2), 16 (.1%) of 14,964 participants in the vaccine group and 62 (1.3%) of 4,902 in the placebo group were confirmed to have Covid-19,” the study states. The vaccine efficacy was 91.6 per cent, the study added.
(Edited by Manasa Mohan)
Also read: DCGI’s Covaxin ‘approval’ is political jumla. It reinforces idea of Modi’s Atmanirbhar Bharat
High time Sputnik V is accorded EUA especially if the ancillary items for production can be sourced from Russia as these items may not be made available by USA and other countries.
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