India’s drug regulatory expert panel on Monday approved restricted emergency use of Russia’s Sputnik V, paving the way for the entry of a third Covid-19 vaccine in India’s inoculation campaign currently open for people 45 years and older.
The subject expert committee (SEC) of the Central Drugs Standard Control Organisation approved an application for the emergency use authorisation for Sputnik V submitted by the Hyderabad-based Dr Reddy’s Laboratories, the PTI reported.
The Russia Direct Investment Fund (RDIF), the country’s sovereign wealth fund and the vaccine’s promoter worldwide, and Dr Reddy’s Laboratories, had last year said they would provide India 100 million doses of Sputnik V after its regulatory approval.
The SEC’s recommendation would need to be accepted by the CDSCO for Sputnik V to be made available in the vaccination campaign which currently uses Covishield, the AstraZeneca vaccine produced by the Serum Institute of India, and Covaxin made by Bharat Biotech.
Sputnik V has shown 92 per cent efficacy in protecting people from Covid-19, the vaccine’s developers have said, reporting the findings of clinical trials, an efficacy slightly higher than those linked to Covaxin or Covishield. Scientists, however, have underlined that the real-world efficacy of all Covid-19 vaccines are yet to be determined.
Health experts have for weeks been advocating the need for India to quickly approve more Covid-19 vaccines to accelerate the campaign and protect more people faster. India has administered 108 million doses of the two vaccines since the start of the campaign nearly three months ago.
But only about 13.6 million people have received the two doses of vaccines needed to protect them from the infection. Advisers to the campaign estimate that India will require around 700 million doses to cover an estimated 350 million people during the current campaign.
“The entry of Sputnik V could speed up the campaign, but the number of doses would need to be matched by both the capacity to administer the vaccines and potential recipients accepting them,” a member of an advisory panel said.
Neither RDIF nor DRL has specified how many doses of Sputnik V would be available to India per month. A senior health official had said earlier this month that the Centre is currently able to procure about 10 million doses from Bharat Biotech and around 70 million doses from Serum per month.