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Panel seeks more data on Russian vaccine, denies emergency use nod
Sputnik V is the next front-runner for approval in India, with the Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee (SEC) reviewing data related to the vaccine’s safety and efficacy.
A committee under India’s drug regulator reviewing the emergency approval application of Russia-made coronavirus vaccine Sputnik V has sought more data, refusing on Thursday to clear the dose just yet, government officials aware of the matter said.
Sputnik V is the next front-runner for approval in India, with the Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee (SEC) reviewing data related to the vaccine’s safety and efficacy.
“The application will be heard again after the manufacturers submit the required data that they have been asked such as to put in place a detailed fact-sheet related to the vaccine, and some additional data on vaccine stability etc. The stability data is on how the product behaves at different temperatures as the product has a couple of variants. Our experts will examine the data pertaining to what suits India’s vaccine delivery system,” said an official familiar with the matter, who asked not to be named.
Dr Reddy’s labs, which is manufacturing the vaccine after a deal with the vaccine’s developer, is carrying out bridging trials in India and has applied for the approval with interim data. The vaccine’s efficacy is pegged at 91.4% based on the final control point of clinical trials in Russia.
In its 144th meeting—held on February 24— to examine Covid-19 related proposal under accelerated approval process, the Central Drugs Standard Control Organisation (CDSCO) subject expert committee 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 subject expert committee 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.
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.
Once approved, Sputnik V will be the third vaccine that will be used in India’s Covid-19 immunisation programme that was launched on January 16, this year.
India currently has two Covid-19 vaccines approved for use—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.
