India’s first mRNA candidate vaccine receives approval for human clinical trials

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

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

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A statement from the science and technology ministry said that mRNA vaccines do not use the conventional model to produce an immune response. Instead, the mRNA vaccine carries the molecular instructions for making the protein in the body through a synthetic RNA from the virus. The host organism uses this to produce the viral protein that is recognized and thus causes the organism to generate an immune response against the disease. MRNA-based vaccines are scientifically the ideal option to tackle a pandemic due to their rapid chronological development, ”the statement said.

He also said that the mRNA vaccine is considered safe as it is non-infectious, does not integrate by nature and is degraded by standard cellular mechanisms. They are expected to be very effective due to their inherent ability to be translated into the protein structure within the cell cytoplasm. The mRNA vaccines are completely synthetic and do not require a host for growth, eg eggs or bacteria. Therefore, they can be quickly manufactured economically under cGMP conditions to ensure their “availability” and “accessibility” for mass vaccination in a sustainable way.

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“The neutralizing antibody response of the vaccine in mice and non-human primates was comparable to sera from COVID-19 convalescent patients. Gennova’s candidate vaccine uses the most prominent spike protein mutant (D614G) and also uses the self-amplified mRNA platform, providing the advantage of a low dose regimen compared to non-replicating mRNA or traditional vaccines. ” added the statement. “HGCO19 uses adsorption chemistry to make the mRNA adhere to the surface of the nano-lipid carrier to improve the release kinetics of mRNA within cells compared to encapsulation chemistry.”

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Gennova has completed all preliminary work and the phase 1/2 human clinical trial will begin soon, as approval has been received from the DCGI office. The vaccines developed by Pfizer Inc and Moderna Inc, which are said to be more than 90% effective, use the mRNA model.

Five vaccine candidates are in different phases of clinical trials in India. Serum Institute of India is conducting a phase 3 trial of the Covid-19 vaccine being developed by the University of Oxford-Astrazeneca. The locally developed vaccine by Bharat Biotech International Limited in collaboration with the Indian Council for Medical Research (ICMR) has already started the phase 3 clinical trial.

Another locally 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 the Covid-19 Sputnik V vaccine in India. Biological E Ltd has also started the first phase 1 and phase 2 human trials of its Covid-19 vaccine candidate.

(With contributions from the agency)