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India’s drug regulator wants more data on Russia’s one-shot Sputnik Light vaccine

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Sputnik V is a two-dose vaccine made from two components – recombinant adenovirus 26 or Ad26 and adenovirus 5 or Ad5 The first dose (Ad26) is the main vaccine, and the second (Ad5) is a booster shot. The Sputnik Light vaccine is made from Ad26, which is the first part of the Sputnik V vaccine.

The Subject Expert Committee (SEC) under India’s drug regulator sought more data on Russia’s Sputnik light, the one shot Covid-19 vaccine, people in the know told ET.

Drug maker Dr Reddy’s laboratories had sought Emergency Use Authorisation (EUA) for Sputnik light from the drug regulator.

The SEC took up their application for review on Tuesday. However, “More data is needed to ascertain if one dose is adequate to provide protection. The company has been asked to submit additional data from the trials in Russia,” said a senior government official.

Sputnik V is a two-dose vaccine made from two components – recombinant adenovirus 26 or Ad26 and adenovirus 5 or Ad5 The first dose (Ad26) is the main vaccine, and the second (Ad5) is a booster shot. The Sputnik Light vaccine is made from Ad26, which is the first part of the Sputnik V vaccine.

Russia’s Gamelya Center had last month said that the Sputnik Light booster dose increased virus neutralizing activity against Omicron. The data was based on sera 2-3 months after re-vaccination.

However, the members of SEC were not convinced and sought more data from the ongoing trials on Sputnik light in Russia, people in the know told ET.

“We are awaiting response and next steps from the SEC, the company spokesperson said.

After launching Sputnik V, Russia introduced a new single-dose vaccine, called Sputnik Light, in May.

India so far has mainly been using two vaccines – Covishield and Covaxin – in its vaccination drive. Last month, the drug regulator granted EUA to Serum Institute of India’s Covovax and Biological E’s Corbevax. ET