An expert panel of the Central Drugs Standard Control Organisation asks company to conduct Phase-3 immune-bridging clinical trials on Indian population. Dr Reddy’s spokesperson declines to say when the trial will start.
Sputnik V vaccine. HAZEM BADER / AFP
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The launch of Sputnik Light single-dose vaccine by Dr Reddy’s in India may take some more time as the company will have to conduct Phase-3 immune-bridging clinical trials on the Indian population.
The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has approved the company proposal to conduct the trials.
Sputnik Light is the first dose of Sputnik V vaccine, which uses the human adenovirus ad26 vector. A Dr Reddy’s spokesperson declined to say when the trial will start.
The SEC asked Dr Reddy’s to assess the primary endpoint at days 42, 90 and 180 and do an interim analysis at day 42 as this data was not generated during Sputnik V trial in India after the first dose, as this data was not generated during the Sputnik V trial in India after the first dose, as its duration was for 21 days.
The minutes of the 172 SEC meeting, which was held on August 8, said that Dr Reddy’s presented the updated safety, immunogenicity and efficacy data of the Phase 3 clinical trial of Sputnik Light vaccine conducted in Russia, along with the proposal to conduct it in India.
Dr Reddy’s has conducted the Phase 3 bridging trial of Sputnik V vaccine, and has received approval for its restricted emergency use in India.
The company holds the sole distribution rights for the first 250 million doses of the vaccine in India, as per its agreement with the Russian Direct Investment Fund (RDIF).
Is it a U turn?
In June, Dr Reddy’s submitted a proposal for the grant of marketing authorisation of Sputnik Light, along with the interim safety and efficacy data generated from Phase 1/2 clinical trials in Russia and presented the Phase 3 clinical trial protocol before the committee.
The committee, after deliberation, asked Dr Reddy’s to present the safety, immunogenicity and efficacy data of the Phase 3 trial that is being carried out in Russia for considering the authorisation in the country.
The safety and immunogenicity data of component-1 in the Indian population has already been generated in the country in another trial. There seems to (be) inadequate data and justification in conducting a separate similar trial,” the SEC said.
After detailed deliberation, the committee recommended that the firm should present the safety, immunogenicity and efficacy data of the Phase 3 clinical trial of Sputnik Light that is being carried out in Russia for considering the proposal for the grant of MA in the country,” it said.
An official at a clinical research firm, who didn’t want to be named, said that the SEC was clarifying its position as the data was not generated for up to 42 days during the Sputnik V trial in India.
But the previous SEC statement did lead to ambiguity, which should have been avoided,” he said.
