The subject matter committee of the Indian drug regulator is expected to take up Dr Reddy's Laboratories' application seeking approval for the Russian coronavirus vaccine Sputnik V this week. The subject expert committee had, last month, rejected the application citing lack of data.
The committee had asked the pharma company to furnish immunogenicity data last month. A government official told The Economic Times that the company has now approached the panel again.
Dr Reddy's had applied for an emergency approval for Sputnik V on February 19. The company had conducted Phase 2 trials in India with around 1,500 participants. Phase 3 trials are still underway.
India already has two approved COVID-19 vaccines that are currently being administered to crores of eligible Indians. So far, frontline and healthcare workers as well as people above 60 years of age and people over 45 years of age with co-morbidities were being administered the vaccines. The government expanded the scope of the priority groups to include people over 45 years of age. From April 1, the vaccination drive will cover everyone over 45 years of age.
India's vaccination drive will get a boost from Sputnik V's approval. Already the Russian Direct Investment Fund, the force behind the Russian vaccine, has signed deals with several Indian companies for the production and distribution of Sputnik V. Hyderabad-based Virchow Biotech Private Limited will produce 200 million doses of Sputnik V, while Bengaluru-based Stelis Biopharma will also produce 200 million doses. Hyderabad-based Gland Pharma will produce 252 million doses and Hyderabad-based Hetero Drug will produce 100 million doses.
According to the interim results published in The Lancet, Sputnik V has an efficacy rate of 91.6 per cent. Apart from Sputnik V, Pfizer and Moderna's vaccines have such high efficacy rate.
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