Indigenous mRNA vaccine receives approval for human trials

India’s indigenous mRNA vaccine, developed by Pune-based Gennova Biopharmaceuticals, has received approval from the Controller General of Medicines of India (DCGI) to conduct phase I / II clinical trials in humans. DCGI’s committee of subject matter experts that met here Wednesday approved its clinical trials.

Gennova’s candidate vaccine, HGCO19, uses the same platform technology as those used by the Covid-19 vaccines developed by Pfizer-BioNTech and Moderna. Its initial grant came from the Ind-CEPI grant from the Department of Biotechnology (DBT), a statement here said on Friday.

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 via synthetic RNA from the virus.

The host organism uses this to produce the recognized viral protein, which causes the organism to generate an immune response against the disease. MRNA-based vaccines are scientifically the ideal choice to tackle a pandemic due to their rapid development. The mRNA vaccine is considered safe as it is non-infectious, not naturally integrated and degraded by standard cellular mechanisms, according to the statement.

They are expected to be very effective due to their inherent ability to translate into the protein structure within the cell cytoplasm. Furthermore, mRNA vaccines are completely synthetic and do not require a host for growth. Therefore, they can be manufactured quickly and inexpensively to ensure their “availability” and “accessibility” for mass vaccination in a sustainable way.

HGCO19, developed in collaboration with HDT Biotech Corporation of the USA, has already demonstrated safety, immunogenicity, and neutralizing antibody activity in animals. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable to sera from convalescent Covid-19 patients.

HGCO19 is stable at 2-8 degrees Celsius for two months. Gennova has completed all preliminary work and should start phase I / II human clinical trials soon.

“The establishment of such an indigenous technology platform will not only allow India to handle the Covid-19 pandemic, but will also ensure preparedness for future outbreaks,” said DBT Secretary Renu Swarup.

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