Dr Reddys fails to secure CDSCO panel nod for Phase 3 trials of Sputnik Light

New Delhi: Denying permission to conduct phase-3 trials on the Russian vaccine Sputnik Light in India, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has asked Dr. Reddy's Laboratories to present the safety, immunogenicity and efficacy data of Phase III clinical trial of SPUTNIK-Light that is being carried out in Russia for considering the proposal for grant of marketing authorization in the country.

This came in response to the proposal submitted by the firm before the committee for the grant of Market Authorization of SARS-CoV-2 virus- (Sputnik Light) Component I along with interim safety and efficacy data generated from the Phase I/II clinical trial in Russia. In addition, the firm also presented the Phase III clinical trial protocol before the committee.

Sputnik Light is a single dose COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology, consisting of the first dose of the Sputnik V vaccine, which is based on the Ad26 vector, and it can be stored at a normal refrigerator temperature of 2–8 °C (36–46 °F).

The Medical Dialogues Team had earlier reported that the Russian Direct Investment Fund (RDIF) had revealed that the single-dose Sputnik Light vaccine demonstrated 79.4% efficacy according to analysed data taken from 28 days after the injection was administered as part of Russia's mass vaccination programme between 5 December 2020 and 15 April 2021.

The proposal presented by Dr Reddy's regarding marketing authorization of SARS-CoV-2 virus- (Sputnik Light) Component I has been thoroughly evaluated during the 163rd SEC meeting to examine the COVID-19 related proposal under the accelerated approval process, conducted on 30.06.2021 at COSCO.

Following extensive analysis, the committee noted that SPUTNIK-Light is same as component -I of SPUTNIK-V. Further, the firm has already tested the safety and immunogenicity of the component-I in the country.

The committee also noted that a Phase II efficacy trial is ongoing in Russia and the efficacy data is yet to be generated.

After detailed deliberation, the committee recommended that the firm should present the safety, immunogenicity and efficacy data of the Phase III clinical trial of SPUTNIK-Light that is being carried out in Russia to consider the proposal for the grant of MA in the country.

Further, as the safety and immunogenicity data of component-I in the Indian population has already been generated in the country in another trial, there seems to be inadequate data and justification for conducting a separate similar trial.