Sputnik V has got Indian regulatory approval, says Russia’s sovereign wealth fund

India’s top drug regulatory body late on Monday gave the Sputnik V Covid-19 vaccine developed by a Moscow laboratory permission for use in an emergency situation, Russia’s sovereign wealth fund said.

The decision came hours after an expert panel of the regulator recommended emergency licensure to the vaccine.

Sputnik V is now the third vaccine to be given such an approval in India after Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin.

“The vaccine has been registered in India under the emergency use authorization procedure based on results of clinical trials in Russia as well as positive data of additional Phase III local clinical trials in India conducted in partnership with Dr. Reddy’s Laboratories,” the Russian Direct Investment Fund (RDIF) said in a statement on the decision.

“We appreciate the decision of India’s regulatory bodies to grant authorization for Sputnik V. Approval of the vaccine is a major milestone as Russia and India have been developing an extensive cooperation on clinical trials of Sputnik V in India and its local production,” RDIF CEO Kirill Dmitriev said.

Including India, 60 countries have now approved this two-dose vaccine, which uses a platform similar to Covishield.

While Dr Reddy’s Laboratories is expected to distribute the vaccine in India, RDIF also has agreements with Gland Pharma, Hetero Biopharma, Stelis Biopharma, Virchow Biotech, and Panacea Biotec to produce more than 850 million doses of Sputnik V in the country for the world.

At the same time, it is not clear how many of these doses have been earmarked for India, and by when the country will be receiving the vaccine for use in its immunisation programme.

As per earlier statements by RDIF, around 200 million doses of Sputnik V are to be supplied to Dr Reddy’s for distribution in the country, which would help vaccinate around 100 million people.

The development comes at a time when some states have raised concerns about potential shortages of Covishield and Covaxin as Covid-19 cases surge. SII CEO Adar Poonawalla had reportedly announced that the company’s ability to scale up production of Covishield to 100 million doses a month has been set back due to the fire that occurred earlier this year at their upcoming facility. The Pune firm will now only be able to reach this capacity by July, he was reported to have said.

On the other hand, Bharat Biotech is still in the process of readying an additional BSL-3 facility in Bengaluru that would help it ramp up annual capacity by 500 million. Until then, its annual supply of Covaxin is limited to around 200 million doses