India’s first mRNA vaccine candidate – developed by Pune-based Gennova in collaboration with the USA’s HDT Bio – has been granted approval to conduct human trials to determine whether it’s safe and produces immune response protective against coronavirus disease (Covid-19).
The Subject Expert Committee under India’s apex drug regulator recommended that the vaccine candidate -- HGCO19 -- to proceed to human trials in a meeting on Wednesday.
The candidate uses the messenger RNA platform to generate immune response just like the vaccines developed by Pfizer and Moderna, which have been found to be 95% efficacious.
Currently, Pfizer has applied for emergency use authorization of its vaccine in India.
Gennova’s candidate, HGCO19, has already demonstrated safety, immunogenicity, and production of neutralising antibodies (antibodies that directly attack the virus) activity in animals. The neutralising antibody response of the vaccine in mice and non-human primates was comparable to the convalescent or recovered patients of Covid-19.
In addition, the mRNA used in the vaccine is attached to a nano-lipid carrier that enhances the release of it inside cells. This self-amplifying platform means requirement of a lower dose of the vaccine.
The vaccine candidate also solves one of the biggest problems with the Pfizer vaccine, which can be stored only at -70 degrees Celsius. Gennova’s vaccine is stable for two months at 2 to 8 degrees Celsius, which is the temperature at which other vaccines used under universal immunisation programme in India is stored.
{{/usCountry}}The vaccine candidate also solves one of the biggest problems with the Pfizer vaccine, which can be stored only at -70 degrees Celsius. Gennova’s vaccine is stable for two months at 2 to 8 degrees Celsius, which is the temperature at which other vaccines used under universal immunisation programme in India is stored.
{{/usCountry}}Gennova has received a seed grant under the Ind-CEPI mission of Department of Biotechnology, which is aligned to the global Coalition for Epidemic Preparedness Innovations (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 getting the disease.
When it comes to manufacturing, mRNA vaccines are synthetically made and do not need cell cultures, bacteria, or other hosts for growing it. This means it can be manufactured quickly and inexpensively.