The subject expert committee (SEC) under India’s drug regulator is likely to meet tomorrow to take up an application of Dr Reddy’s Laboratories seeking approval to market the Sputnik V Covid-19 vaccine, a government official told ET. Earlier last month, the SEC had rejected the application, citing lack of data.
“The committee has asked the company to come back with immunogenicity data. Now that they have approached again with the data, the SEC is likely to take it up this week,” a government official said, asking not to be identified.
Dr Reddy’s had approached the regulator earlier on February 19 to get emergency approval for Sputnik V. The drug company had conducted phase-2/3 clinical trials in India on about 1,500 participants. According to the company, phase-3 trials are still under way. The approval to Sputnik V will give a further boost to the vaccine drive that has been expanded by the government to cover those above 45 years of age.
The Sputnik V vaccine has demonstrated an efficacy rate of 91.6%, according to interim results published in The Lancet.
Efficacy is an indicator of the ability of a vaccine to prevent symptomatic cases of coronavirus in a group of people that’s been inoculated.
Sputnik V and the vaccines made by Pfizer and Moderna are the only three vaccines in the world that have such a high efficacy. Priced at less than $10 per dose in the international markers, the vaccine has been administered to over 2 million people worldwide.
Dr Reddy’s tied up with Russian Direct Investment Fund (RDIF) in September last year to conduct clinical trials of Sputnik V and distribute the vaccine in India. RDIF backed the development and production of Sputnik V.
India started its Covid-19 vaccination drive on January 16 with the Covishield vaccine made by Serum Institute of India and Covaxin, produced by Bharat Biotech. Covaxin was approved for use in the absence of efficacy data, prompting criticism and reluctance of some healthcare workers to take the shot.
The entry of another vaccine could inject much-required pace to the vaccination drive in India, public health experts said.