Expert panel recommends approval of Sputnik V vaccine in India

An expert committee of the country’s drug regulator approved the use of Russian vaccine Sputnik V on Monday (April 12). This will be India’s third vaccine against the COVID-19 infection after Covishield and Covaxin.

The Drugs Controller General of India’s (DCGI) Subject Expert Committee (SEC) met and discussed the application of Sputnik V for emergency use authorisation. The DGCI will now consider the SEC’s recommendation. 

The two-dose vaccine, developed by the Moscow-headquartered Gamelaya Institute and manufactured in India by Dr Reddy’s Laboratories, has an effectiveness of 91.6 per cent. 

Dr Reddy’s, which had tied up with Russian Direct Investment Fund (RDF) to produce the vaccine doses, had applied for emergency use of Sputnik V on February 19. The RDF has partnered with other pharmaceutical players as well, such as Virchow Biotech Private Limited, to produce up to 200 million doses per year of Sputnik V in India, and with Stelis Biopharma Pvt Ltd and Panacea Biotec to produce 200 million and 100 million doses per year.

With a production capacity of 850 million doses in the country, Sputnik V is expected to  provide a major shot in the arm in India’s fight against COVID-19. 

Also read: Sputnik V vaccine to be shortly available in India: Dr Reddy’s official

Sputnik V, which is undergoing Phase 3 clinical trials in India, the UAE, Venezuela and Belarus, is being tested on around 1,600 people between the age group of 18 and 99.The vaccine, deemed as the “world’s first vaccine” to be registered by Russian President Vladimir Putin has reportedly demonstrated the same level of efficacy in all age groups. 

This vaccine uses a weakened COVID virus to deliver parts of a pathogen to stimulate an immune response in the body.

In their last meeting on April 1, the SEC had asked Dr Reddy’s to submit data to elaborate on how the body’s immune response is activated against the coronavirus, reported NDTV. Moreover, they also wanted to know about all the unblinded data of all the serious adverse events and a comparative analysis of Phase 3 data generated on Indian and Russian studies at various times.

Also read: Clinical trial: 17 volunteers given Russia’s Sputnik V vaccine in Pune

This approval for a third vaccine comes in the backdrop of India registering the sixth record rise in seven days with 1,68,912 new COVID cases in 24 hours. India is currently in the third phase of its mega COVID-19 vaccination drive, which started on January 16, 2021.

Meanwhile, India is expected to get four more additional vaccines by Q3 of this year, media reports said quoting government sources. Besides Sputnik V, there will be Johnson & Johnson’s vaccine (in collaboration with Bio E), Novavax vaccine (in partnership with Serum India), Zydus Cadila’s vaccine, and Bharat Biotech’s Intranasal Vaccine.