Published 11:09 IST, December 12th 2020
India's first mRNA vaccine candidate for Covid-19 heads for human trials
India's 1st indigenous mRNA vaccine candidate has received approval from Indian Drug regulators to initiate combined Phase I/II human clinical trial.
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In a major development in India's battle against the COVID-19 pandemic, country's first indigenous mRNA vaccine candidate has received approval from Indian Drug regulators to initiate combined Phase I/II human clinical trial. The nod was given on the basis of data obtained from animal studies, but the company will still have to submit interim results from the first part of the trial before beginning the next. The novel mRNA vaccine candidate, HGCO19 has been developed by Gennova Biopharmaceuticals, Pune, and supported with a seed grant under the Ind-CEPI mission of the Department of Biotechnology of Union Ministry of Science and Technology.
India's 1st mRNA vaccine candidate gets nod for human trials
As per the Ministry of Science and Technology's release, the mRNA vaccine does not use the conventional model to produce an immune response. Instead, the mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus. Later, the host body uses this to produce the viral protein that is recognized and thereby making the body mount an immune response against the disease. The mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline," the release said.
Calling the mRNA vaccine safe, non-infectious, non-integrating in nature and degraded by standard cellular mechanism, the release said that they are expected to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm. Stating that mRNA vaccine is fully synthetic and does not require a host for growth, for example, eggs or bacteria, the release informed that the vaccines can be quickly manufactured in an inexpensive manner under cGMP conditions to ensure "availability" for mass vaccination on a sustainable basis.
The release said, “HGCO19 uses the adsorption chemistry so that the mRNA is attached on the surface of the nano-lipid carrier to enhance the release kinetics of the mRNA within the cells compared to the encapsulation chemistry.”
Gennova Biopharmaceuticals has completed all preliminary work and should be initiating the Phase 1/2 human clinical trial soon since the approval from the DCGI office has been received. The vaccines developed by Pfizer Inc and Moderna Inc, which are said to have over 90% efficacy, use the mRNA model.
5 vaccine candidates are under currently different phases of clinical trials in India. Serum Institute of India is conducting Phase 3 trial of the Covid-19 vaccine being developed by Oxford University-AstraZeneca. The indigenously-developed vaccine by Bharat Biotech International Limited in collaboration with ICMR has already started the Phase 3 clinical trial.
Another indigenously-developed vaccine by Zydus Cadila has also completed Phase 2 clinical trials in the country. Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) have also announced the start of adaptive Phase 2 and Phase 3 clinical trials for Covid-19 vaccine Sputnik V in India. Biological E Ltd has also started early Phase 1 and Phase 2 human trials of its Covid-19 vaccine candidate.
(With PTI inputs)
11:09 IST, December 12th 2020