NEW DELHI: As India faces an avalanche of Covid cases, the expert panel of the apex drug regulator on Monday recommended the use of Russia’s Covid vaccine Sputnik V in the country’s vaccination drive.
This approval comes amidst the clamour to approve other Covid vaccines in India irrespective of their bridging trial status in the country.
The authorities too concede that while bridging trial data from the country is required to authorize the use of any vaccines in the country under the existing norms, it may be exempted under the present clinical trial norms.
Sputnik V, based on human adenoviral vectors, is one of only three vaccines in the world, along with those by Pfizer and Moderna, with an efficacy of over 90%.
The two-dose vaccine which has to be administered 21 days apart, costs about $10 or Rs 750 per dose in the international market.
The decision in India comes after the Central Drug Standards Control Organization’s subject expert committee on Covid met on Monday to consider the Sputnik V application for Emergency Use Authorization in India.
The vaccine developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology which has shown nearly 91.6% efficacy against infection and 100% efficacy against severe disease had become the world’s first registered vaccine against Covid-19 in August last year.
The adenovirus-based vaccine can be stored at a comfortable 2-8 degree Celsius and is also being produced in the lyophilized (dry) form which makes it easier for distribution purposes.
Dr Reddy’s Laboratories, along with at least four other companies, have tied up with the Russian Direct Investment Fund -- the codeveloper of Sputnik V, for the vaccine’s production in India.
Top sources in the drug regulator said that the Drug Controller General of India will now consider SEC recommendation for the third Covid vaccine to be available in India amid reports of vaccine shortage in many states.
The first two are Serum Institute of India's locally-made AstraZeneca- Oxford University Covid-19 vaccine Covishield and Bharat Biotech's indigenously manufactured Covaxin.
Sputnik V is likely to be imported from Russia initially for emergency use in the country, government sources said.
India is currently in the third phase of its mega Covid-19 vaccination drive which began on 16 January 2021. So far, nearly 10.5 crore vaccine doses have been administered through 15,56,361 sessions, as per the provisional report till Monday morning.
Last Friday, CDSCO’s expert panel had sought additional data from drugmaker Dr.Reddy's Laboratories on its Sputnik V Covid vaccine trial, in its second such request after an initial evaluation in February.
The committee had earlier also asked the firm to submit a comparative analysis of late-stage immunogenicity data from both its Indian studies and an ongoing Russian study, as well as data on serious adverse events and positive cases reported to date.