DCGI seeks more data for Sputnik V emergency use approval in India

| | New Delhi
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DCGI seeks more data for Sputnik V emergency use approval in India

Friday, 26 February 2021 | PNS | New Delhi

Sputnik V, the Russian vaccine against the Covid-19, will have to wait longer to get approval for emergency use authorisation (EUA) in India.

The country’s top drug regulator’s subject expert committee (SEC) has asked Hyderabad-based Dr Reddy’s Laboratories to submit more data before a final decision could be taken about its fate.

Dr Reddy’s Lab  is locally conducting clinical trials on Sputnik V.

The DCGI decision seeking more data from Dr Reddy’s has been slammed by a section of health experts.  They contended when the Covishield by Serum Institute of India and Covaxin by Bharat Biotech can get EUA without complete data, then why the nod for the Russian vaccine was being held up despite it showing good preliminary results.

Dr Reddy’s Lab had applied to the Central Drugs Standard Control Organisation on February 19 for EUA as the human adenoviral vector-based vaccine candidate.

The subject expert committee (SEC) took up the application on Wednesday, but did not give emergency use authorisation on the basis of the current data set that was produced before its members.

“The subject expert committee has sought more data such as the immunogenicity data from the company. The application has not been rejected, they will be given a chance to present their case once again after they have all the relevant documents,” said a senior Government official on the condition of anonymity.

The company had presented the safety profile of Phase 2 clinical trials, and interim data from Phase 3 trials.

However, Dr Giridhara R Babu, Bengaluru-based epidemiologist questioned the DCGI stand and asked, “What’s the rationale for differential decisions? Phase 3 of Sputnik published similar to Covieshield based on data from other countries. No results from the latter on bridging study but approved for use. Covaxin is approved without phase 3 results,” he tweeted.

Dr Rahul Bhargava, Director-Bone Marrow Transplant Programme, Fortis Memorial Research Institute, Gurugram too termed “wrong” the DCGI’s move to hold the approval decision.

He pointed out that Covaxin was given EUA in January this year based on 1,500 patients data (phase I and II data). He also pointed out that while Covishieldh had a data from 23,000 patients from European countries, but it had a very low number of Indian patient data. In contrast, Sputnik has efficacy data of 91 per cent with 15,00 subjects, has not been given the nod, he asserted.

A study published in The Lancet said, “Russia’s Sputnik V vaccine demonstrated efficacy of 91.6 percent against Covid-19, according to interim results of Phase 3 trials.”

Several countries like Argentina, Venezuela, UAE, Iran have also started giving Sputnik V jabs to their citizens. The vaccine is undergoing phase 3 clinical trials in India, Dr Bhargava noted.

In September last year, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and for its distribution rights in India.

According to the RDIF, Egypt has recently approved Russia’s Sputnik V vaccine against Covid-19, becoming the 34th country outside of Russia and third in North Africa to do so. RDIF, Russia’s sovereign wealth fund is responsible for marketing the vaccine abroad.

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