CDSCO panel nod to phase 3 trials of Sputnik V by Hetero Pharma
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has given a green signal to Hetero Biopharma to start phase 3 trials for Sputnik V, the Russian Covid-19 vaccine that will be manufactured in India.
This conditional approval came following a proposal presented by the Hetero to conduct a Phase III clinical trial of COVID-Vac Combined Vector Vaccine, manufactured by it.
Sputnik V, also known as Gam-COVID-Vac, is a viral two vector vaccine made up of two adenovirus vectors, Ad5 and Ad26, into which the SARS-CoV-2 full-length glycoprotein S gene was inserted. It was developed by the Gamaleya Research Institute of Epidemiological and Microbiology.
The Medical Dialogues team had earlier reported that in September 2020, Dr Reddy's had collaborated with the Russian Direct Investment Fund to conduct Sputnik V clinical trials and obtain distribution rights in India. On April 12, 2021, India's drug regulator granted permission for the restricted emergency use of the Russian COVID-19 vaccine 'Sputnik V' with certain conditions, paving the way for a third vaccine to be available in the country.
It was further reported that RDIF had signed agreements with major pharmaceutical firms in the region, including Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech, and Shilpa, to manufacture over 850 million doses each year, enough to vaccinate over 425 million people.
Now, Hetero Biopharma has sought DCGI permission to conduct a Phase III clinical trial of Russian Sputnik V, COVID-Vac Combined Vector Vaccine which is manufactured by Hetero Biopharma.
The proposal was deliberated during the 153rd SEC meeting to examine COVID-19 related proposal under an accelerated approval process held on earlier this month.
Responding to the firm's submission, the CDSCO committee recommended for grant of permission to conduct Phase III clinical trial subject to the following conditions;
1. The immunogenicity samples should be taken at Day 21, 28 and 42.
2. Neutralizing antibodies and gamma interferon should be assessed during the study.
"Accordingly, CDSCO may grant approval for the conduct of the clinical trial." the committee added.
According to The Hindu, Hetero's Phase III trial will be a bridging trial, which will be part of the approval process for the Russian vaccine's manufacturing and use in India. The procedure such as transferring technology, inspecting the laboratory, and obtaining other vaccine clearances may take two months.
On the other hand, the Medical Dialogues team had reported earlier that India will start receiving Russia's Sputnik V Covid-19 vaccine by the end-May according to its local distributor, Dr Reddy's Laboratories.