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Panel grants emergency-use approval to Russia-made Covid vaccine Sputnik V
In September 2020, Dr Reddy’s and Russian Direct Investment Fund (RDIF) entered into a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for distribution in India
A committee under India’s drug regulator reviewed and approved the emergency-use application of Russia-made coronavirus vaccine Sputnik V on Monday based on its strong immunogenicity data.
The Drugs Controller General of India will be formally approving the vaccine under emergency-use based on the expert panel recommendation.
In an earlier meeting, the subject expert committee (SEC) of the central drugs standard organisation (CDSCO) sought more data from Dr Reddy’s labs, which is conducting bridging clinical trials for the Russia-made Covid-19 vaccine locally. The vaccine’s efficacy is pegged at91.6% based on the final control point of clinical trials in Russia.
Sputnik V was the next front-runner for approval in India, after Bharat Biotech’s Covaxin that is co-developed by Indian Council of Medical Research, and Oxford-AstraZeneca vaccine that is locally manufactured by Serum Institute of India under the brand name Covishield.
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Both the vaccines are currently approved for use in India for the national Covid-19 immunisation programme. India launched its nationwide Covid-16 immunisation drive on January 16, 2021, and since then has administered at least 100 million Covid-19 vaccine doses.
In September 2020, Dr Reddy’s and Russian Direct Investment Fund (RDIF) entered into a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for distribution in India.
Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the ministry of health of Russia and became the world’s first registered vaccine against Covid-19 based on the established human adenoviral vector platform.
In its 144th meeting—held on February 24—to examine Covid-19 related proposal under accelerated approval process, the CDSCO SEC asked the company that presented its case for grant of emergency-use authorisation, to come back with more India-specific immunogenicity data.
“The firm presented its proposal for grant of permission to import (marketing authorisation) for emergency-use of Gam COVID Vac Combined Vector vaccine (Component one and component two) along with the safety & immunogenicity data of Phase II part of Phase II/III clinical trial in India and interim safety, efficacy & immunogenicity data from overseas Phase III clinical trial,” said the SEC in its previous meeting to consider Sputnik’s application, according to the minutes of the meeting made public.
“After detailed deliberation, the committee recommended that firm should submit immunogenicity and safety data of Phase II and III trial as per approved protocol for further consideration of the Committee. Further the firm is requested to present its data with more clarity,” the committee recommended.
