New Delhi: The subject expert committee of India’s drugs regulatory agency has recommended Russia’s Covid vaccine Sputnik V for emergency use authorisation. If the government accepts Central Drugs and Standards Control Organisation’s recommendation, Sputnik V will be the third vaccine to be used in India.
Interim analysis of the Phase 3 trial conducted in Russia had shown that Sputnik V has a 91.6 per cent efficacy against Covid-19, according to the findings published in peer-reviewed journal The Lancet. In India, the vaccine is being manufactured by Hetero and Panacea Biotech. The clinical trials (bridging studies) are being conducted by Dr Reddy’s Laboratories.
According to the information available on the vaccine’s official website: “Sputnik V is one of the three vaccines in the world with efficacy of over 90%. The vaccine’s efficacy is confirmed at 91.6% based on the analysis of data on 19,866 volunteers, who received both the first and second doses of the Sputnik V vaccine or placebo at the final control point of 78 confirmed COVID-19 cases. RDIF with partners and manufacturers is ramping up the production of Sputnik V. The cost of one dose of the vaccine for international markets is less than $10 (Sputnik V is a two- dose vaccine). The vaccine can be stored at a temperature of +2 to +8 degrees Celsius, which allows for easy distribution worldwide, including hard-to-reach regions.”
The vaccine is expected to cost about $10 (approximately Rs 750) in India.
There is no formal communication on the development from the health ministry. However, sources confirmed that the SEC recommendation was handed over to the ministry by drugs controller Dr V.G. Somani and joint drugs controller S. Eswara Reddy. There is no clarity on whether it will be part of the government programme or will be available for sale at pharmacies.
Approval would come at a crucial juncture
If the recommendation of the subject expert committee is accepted by the government, it will come at a crucial time when India is struggling to maintain vaccine flows. Days after Prime Minister Narendra Modi announced a four-day Tika Utsav (vaccine festival) that kicked off Sunday, several states including Maharashtra, Rajasthan and Odisha are facing acute vaccine shortages.
India has so far administered 10,45,28,565 doses of Covid vaccines — Bharat Biotech’s Covaxin and Serum Institute’s Covishield — but the two are not being manufactured in adequate quantities.
Bharat Biotech which manufactures Covaxin, which is India’s indigenous vaccine, is struggling to meet its stated capacity of one crore per month. Serum Institute of India recently told the government that it can manufacture about 6-6.5 crore doses per month.
“None of the vaccine makers currently approved are meeting their commitment and we are facing the flak. We are distributing vaccines the moment the supplies come in, yet states are complaining,” said a senior health ministry official.
(Edited by Neha Mahajan)