India-based pharma major Dr Reddy's on Thursday, 1 July, said that the government has allowed single-dose Sputnik Light to submit Russian safety data in India, reported news agency ANI.
This comes hours after ANI reported, quoting sources, that the Drugs Controller General of India (DCGI) had denied permission to Dr Reddy’s to conduct Phase 3 trials for the COVID vaccine in India.
As per The Times of India, sources had said that the subject expert committee (SEC), which comes under the drug regulator, did not find any 'scientific rationale' to conduct the trials.
According to NDTV, the statement from Dr Reddy's on Thursday said that the Centre's Subject Expert Committee (SEC) had decided to consider Russian efficacy data on Sputnik Light vaccine and there was no need to conduct a separate trial.
"In view of the fact that (1) Sputnik Light is the first dose component of Sputnik V, and Dr Reddy's has already generated safety and immunogenicity data on the first dose component in India through its clinical trial and; (2) a Phase 3 efficacy trial is currently underway in Russian on Sputnik Light, the SEC recommended that Dr Reddy's should submit safety, immunogenicity, and efficacy data from the Phase 3 clinical trial of Sputnik V in Russia to the SEC for its consideration of Marketing Authorisation of Sputnik Light in India," the statement read, according to the report.
Sputnik Light is a single-dose vaccine with a reported efficacy of 79.4 percent, the launch of which was announced on 6 May, by the Russian Direct Investment Fund (RDIF).
The vaccine, developed by Moscow's Gamaleya Institute, has an efficacy level higher than that of many two-dose vaccines and can be an effective way to vaccinate large populations.
On Covavax Trials on Children
Meanwhile, as per ANI’s sources, the Centre’s panel has also recommended against permitting Serum Institute of India (SII) to conduct phase two and three clinical trials of the Covavax COVID-19 vaccine on children aged 2-17 years.
The panel has asked SII to complete trials of the jab on adults first.
As of 5 May, SII had started a Phase II/III observer-blinded, randomised, active-controlled trial of Covavax with 1,600 participants over the age of 18 across 15 centres. The launch of Covavax was delayed in India due to issues pertaining to the export of raw material from the US.
On 15 June, Niti Ayog member Dr VK Paul, had said that the results of Novavax (called Covavax in India) are 'promising'.
“What we're learning from the data available in public domain is that this vaccine is very safe and highly effective. It'll be produced in India. Clinical trials are being conducted and are in advanced stage of completion.”Dr VK Paul
Further, he had been quoted by ANI as saying, “There will be some gap in production (of Novavax vaccine) for a while. I am also hoping they (US company Novavax) would also start trials on children too.”
(With inputs from ANI.)
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