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Committee likely to take up Sputnik V emergency-use authorisation plea today
In its 144th meeting—held on February 24— the subject expert committee asked the company to come back with more India-specific immunogenicity data
The subject expert committee (SEC) of the national drugs regulator is likely to meet on Monday to consider Dr Reddy’s Laboratories’ emergency-use authorisation (EUA) application for the Russian anti-Coronavirus disease (Covid-19) vaccine Sputnik V, officials aware of the matter have confirmed.
“The subject expert committee meetings are being held regularly to speed up analysis of Covid-19 related approval requests, and may meet today to consider the case of Sputnik V, after the firm submitted the additional data that was sought by the experts,” said an official from the centre in the know of things, who did not wish to be identified.
On February 19, Dr Reddy’s applied for emergency-use authorisation in India for the Russian Covid-19 vaccine.
In its 144th meeting—held on February 24— to examine Covid-19-related proposals under the accelerated approval process, the 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.
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“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.
“After a detailed deliberation, the committee recommended that firm should submit immunogenicity and safety data of Phase II and III trials 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.
The vaccine’s efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials in Russia.
