The Drugs Controller General of India (DCGI) has given restricted emergency use authorisation (EUA) to single-dose Covid-19 vaccine Sputnik Light, according to Union Health Minister Mansukh Mandaviya.
“This is the 9th Covid-19 vaccine in the country,” he said adding this will “further strengthen the nation’s collective fight against the pandemic.”
The approval comes after Dr Reddy’s Laboratories said it has submitted a proposal to the DCGI to register Sputnik Light vaccine as a booster dose against COVID-19.
Dr Reddy’s Laboratories presented its proposal for grant of permission to import Sputnik Light for a restricted use in an emergency situation and booster-dose vaccination, along with the analysis of the latest safety and efficacy data, including its benefits against the Omicron variant of the coronavirus. The firm said the Sputnik Light vaccine is approved in 29 countries, including Argentina, Russia etc.
An expert panel of India’s central drug authority on Friday recommended granting restricted emergency authorisation to Sputnik Light subject to various regulatory provisions.
“The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application by Dr Reddy’s Laboratories, noted that the safety and immunogenicity data presented by the firm from the Indian study is comparable with that of the ongoing phase-3 clinical trial interim data from Russia,” a source said. The interim data of the efficacy trial from Russia has shown an efficacy of 65.4 per cent against COVID-19, 21 days after immunisation.
“After detailed deliberations, the SEC recommended for grant of permission for a restricted use in an emergency situation, subject to various regulatory provisions,” the source said.
Last year, the company received permission from the DCGI to import the Sputnik vaccine into India for restricted use in emergency situations in April. “As regards to Sputnik, we are now ready with capacities in India. We are working actively with the Government of India for registering Sputnik Light as a vaccine and as a booster dose of Sputnik V,” Dr Reddy’s Laboratories CEO Erez Israeli said in an analyst call.
“Sputnik continues to be a viable option for Dr Reddy’s for India and other countries,” Israeli stated. He noted that the company will have to get approval from the authorities in India for the protocol of the trial.
“And pending that approval of that protocol, we will have a trial with other vaccines so it will serve as another option both private as well as the government for the booster in the future. We believe that the boosters will be part of our life and we’ll have to take it once or twice a year now,” Israeli said. On exports, he noted that there were no restrictions on the overseas shipment of the vaccine.
