Dr Reddy’s resubmits application for combined phase 2&3 trials

Our Bureau Hyderabad-based Dr Reddy's Laboratories has resubmitted its application seeking permission from the Drug Controller General of India (DCGI) to conduct combined phase 2 and 3 clinical trials of the Russian Covid-19 vaccine, Sputnik V, in the country.

Now, the DGCI will send the application to the Subject Expert Committee. The committee, in its meeting on October 5, had asked Dr Reddy’s to resubmit its application as it had sought permission for carrying out phase 3 clinical trials directly on the basis of phase 1-2 trials conducted in other countries. As the committee felt that the safety and immunogenicity data submitted by Dr Reddy's was from a small base in other countries, and no data was available from Indian subjects, it asked the firm to conduct reapply for a combined phase 2-3 trials rather than phase 3 trials alone.

In mid-September, the Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, entered into a pact with Dr Reddy's for carrying out clinical trials of Sputnik V in India. It agreed to supply 100 million doses of the vaccine, developed by the Gamaleya National Research Center of Epidemiology and Microbiology in Russia. The vaccine, which uses an adenovirus platform, is already undergoing phase 3 clinical trials in Russia and other countries on 40,000 healthy subjects.

RDIF said deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.

Other candidates

Currently two indigenously developed vaccine candidates — one by Bharat Biotech in collaboration with ICMR and another by Ahmedabad-based Zydus Cadila — are in phase 2 human clinical trials.

The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford Covid-19 vaccine candidate, is conducting phases 2 and 3 human clinical trials in India.