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DCGI rejects Dr Reddy’s application to conduct phase 3 trials of single-dose Sputnik Light in India

The Indian drug regulator has denied permission to Dr. Reddy’s Laboratories for conducting Phase 3 trials of the Russian COVID-19 single-dose vaccine Sputnik Light in India.

Dr. Reddy’s Laboratories had recently said it was working with Indian regulators to bring the single-dose Sputnik Light coronavirus vaccine to the country.

Developed by Gamaleya National Research Center of Epidemiology and Microbiology, Sputnik Light received authorisation in Russia in May this year.

Sputnik Light has 79.4 per cent efficacy

It is the first component of Sputnik V, which was registered in August 2020, and is based on the human adenovirus, which transmits genetic information of the novel coronavirus.

According to the Russian Health Ministry, data collected from 28 days after the shot showed that the vaccine has 79.4 per cent efficacy compared to 91.6 per cent for the two-shot Sputnik V.

The manufacturer of the single-shot vaccine claims it has proven effective against all new strains of the coronavirus and has demonstrated no serious side effects.

Sputnik Light not approved by US FDA, EMA 

Sputnik Light will cost less than USD 10 globally but it has not yet been approved by the European Medicines Agency (EMA) or the United States’ Food and Drug Administration (FDA).

On June 29, India’s drug regulator DCGI granted permission to Mumbai-based Cipla to import Moderna’s COVID-19 vaccine for restricted emergency use in the country.

After Covishield, Covaxin and Sputnik, Moderna’s vaccine will be the fourth COVID-19 jab to be available in India.

In a bid to expedite the rollout of vaccines amid a sharp rise in COVID-19 cases during the second wave, the DCGI had decided to waive testing of batches at CDL for foreign-manufactured vaccines approved by international drug regulators such as the US FDA, the UK’s MHRA or the WHO on June 1.

As per the guidelines, these vaccines will not undergo prior bridging trials in India and the provision was further amended to waive the trial requirement for the well-established vaccines manufactured in other countries.

 

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