India

India’s first mRNA vaccine candidate gets nod for human clinical trials

India’s first indigenous Covid-19 vaccine candidate, the mRNA one being developed by Pune-based Gennova Biopharmaceuticals, has received approval from drug regulators to initiate combined Phase 1/2 trials human clinical trial, the government said on Friday. The nod was given on the basis of data from animal studies but the company well have to submit interim results from the first part of the trial before starting the next.

The novel mRNA vaccine candidate, HGCO19, has been developed by Gennova and supported with a seed grant under the Ind-CEPI mission of the department of biotechnology of the Union ministry of science and technology. Gennova has worked in collaboration with US’ HDT Biotech Corporation to develop the mRNA vaccine candidate. HGCO19, which is stable at 2-8 degrees Celcius for two months, has already demonstrated safety, immunogenicity, neutralisation antibody activity in animals.

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A release from the ministry of science and technology said the mRNA vaccines do not use the conventional model to produce an immune response. “Instead, mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus. 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.

It also said the mRNA vaccine is considered safe as is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. They are expected to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm. mRNA vaccines are fully synthetic and do not require a host for growth, for example, eggs or bacteria. They can, therefore, be quickly manufactured in an inexpensive manner under cGMP conditions to ensure their “availability” and “accessibility” for mass vaccination on a sustainable basis.

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“The neutralizing antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19. Gennova’s vaccine candidate uses the most prominent mutant of spike protein (D614G) and also uses the self-amplifying mRNA platform, which gives the advantage of a low dosing regimen compared with the non-replicating mRNA or traditional vaccines,” the release added. “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.”

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Gennova 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.

Five vaccine candidates are under 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 the Indian Council of Medical Research (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.

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