India’s first mRNA vaccine candidate, developed by Pune-based Gennova in collaboration with US HDT Bio, received approval for human trials to determine if it is safe and produces a protective immune response against the coronavirus disease (Covid-19).
The Indian drug regulator’s Subject Matter Expert Committee recommended that the candidate vaccine, HGCO19, proceed to human trials at a meeting on Wednesday.
The candidate uses the messenger RNA platform to generate an immune response like the vaccines developed by Pfizer and Moderna, which have been shown to be 95% effective.
Currently, Pfizer has applied for emergency use authorization for its vaccine in India.
Gennova’s candidate, HGCO19, has already demonstrated safety, immunogenicity, and production of neutralizing antibodies (antibodies that directly attack the virus) in animals. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable to that in convalescent or recovered Covid-19 patients.
In addition, the mRNA used in the vaccine is bound to a nano-lipid carrier that enhances its release within cells. This self-amplifying platform means the requirement for a lower dose of the vaccine.
The candidate vaccine also solves one of the biggest problems with the Pfizer vaccine, which can only be stored at -70 degrees Celsius. Gennova’s vaccine is stable for two months between 2 and 8 degrees Celsius, which is the temperature at which other vaccines used in the universal immunization program in India are stored.
Gennova has received an initial grant within the framework of the Ind-CEPI mission of the Department of Biotechnology, which is aligned with the Global Coalition for Innovations in Epidemic Preparedness (CEPI).
An mRNA vaccine uses a synthetic RNA (genetic material) encoded with instructions to make specific proteins of the Sars-CoV-2 virus so that the body can generate an immune response without contracting the disease.
When it comes to manufacturing, mRNA vaccines are made synthetically and do not need cell cultures, bacteria, or other hosts for cultivation. This means that it can be manufactured quickly and inexpensively.
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