The country’s first indigenous mRNA vaccine candidate has received approval to initiate phase 1 and 2 human clinical trials from Indian drug regulators, the Ministry of Science & Technology said in a press release.
The vaccine, being developed by Pune-based Gennova Biopharmaceuticals, is stable at 2-8°C for two months.
The technology is relatively new and has not been used for vaccines so far. Pfizer, the first company to receive emergency use authorisation in the UK, also uses the same approach.
These mRNA vaccines carry 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.
Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, e.g., eggs or bacteria. “Therefore, they can be quickly manufactured in an inexpensive manner under cGMP conditions to ensure their "availability" and "accessibility" for mass vaccination on a sustainable basis,” the press release said.
Gennova, in collaboration with HDT Biotech Corporation, Seattle, USA, has worked together to develop the vaccine, called HGCO19. The Department of Biotechnology had earlier said it has provided seed funding for the development of Gennova's novel self-amplifying mRNA-based vaccine candidate for Covid-19.
The firm earlier said that the vaccine demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models.
Dr Renu Swarup, Secretary, Department of Biotechnology and Chairperson BIRAC, said, “Establishment of a such indigenous technology platform will not only empower India to handle the COVID-19 pandemic but also ensure the preparedness for future outbreaks".
(With inputs from IANS)
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