Russian Vaccine Sputnik V gets emergency use authorisation in India

With an unprecedented spike in daily Covid-19 cases, India on Monday moved closer to getting a third vaccine against the novel coronavirus when the independent panel of the drug regulator gave Russian-made Sputnik V its nod for emergency use authorisation.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) approved the vaccine that uses the adenovirus platform, very similar to that used by Covishield, a week after seeking additional data from Dr Reddy’s Laboratories. Dr Reddy’s is carrying out the bridge Phase 2/3 trials for Russian Direct Investment Fund (RDIF), which is behind Sputnik V. Dr Reddy’s is also in for marketing for the vaccine in India.

With the SEC nod, a formal approval from CDSCO is a mere formality for Sputnik V vaccine, which will be manufactured by six Indian pharma companies under licence from RDIF. The SEC decision to allow Sputnik V for emergency use came on a day India recorded the highest-ever daily Covid-19 tally of 1,68,912 cases.

Developed by Gamaleya Research Institute of Epidemiology and Microbiology, Sputnik is the third Covid-19 vaccine to be approved for use in India after Covishield of Serum Institute of India and Covaxin of Bharaat Biotech.

DCGI to consider Russian vaccine Sputnik V for emergency use today
Apart from a comprehensive agreement with Dr Reddy’s, including the conduct of clinical trials, RDIF has collaborations with Hetero, Gland Pharma, Stelis Pharma, Virchow, and Panacea Biotech. For the Russian agency, this translates to over 1,000 million doses of Sputnik V.

According to industry sources, a couple of new tie-ups are in the works that can step up production even higher.

According to the reports, the vaccine production is expected to gain traction during the second and third quarters of 2021-22. As they are also meant for meeting global requirements of Sputnik, it remains to be seen how many doses will be available for the Indian market.

There is also little clarity on the price of the vaccine in India. According to a statement by Health Secretary Rajesh Bhushan a few weeks ago, Sputnik V’s global price is around $10 per dose, which is nearly four times the price at which other two India-made vaccine are sold in the domestic market. Though the government is expected to do a hard bargaining with the Russians, sources in the know are tight-lipped about the final price of the vaccine.

In line with the agreement, RDIF is to supply 100 million doses of Sputnik V to Dr Reddy’s after the approval by the Indian regulator.