India’s first homemade mRNA vaccines have received approval to start human trial on Friday, December 11th, 2020. The mRNA vaccine which is developed by the Pune-based Gennova gets DGCI’s nod to initiate Phase I/II human clinical trial. The mRNA vaccine has been code named as HGCO19.
“HGCO19 has already demonstrated safety, immunogenicity, neutralization antibody activity in animals. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19,” a government statement read.
The development in Pune was supported with seed grant under the Ind-CEPI mission of the Department of Biotechnology of M/O Science and Technology. The HGCO19 does not use the conventional model to immune response. The vaccine, instead, carries the mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus.
“The mRNA vaccines do not use the conventional model to produce an immune response. Instead, mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus,” the statement read further.
It is being said that the mRNA vaccine could be ideal for the Indian weather. Along with that, it is also being considered that the homemade vaccine is safe as it is non-infectious, non-integrating in nature. It gets degraded by the standard cellular mechanism. It is being expected that it would be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm.
“HGCO19 remains stable at 2-8 degrees Celsius for two months,” the government said in the statement. Since the mRNA vaccines are fully synthetic and do not require a host for growth like eggs or bacteria, it can be easily manufactured. The price of the vaccine to come inexpensive under cGMP conditions that would ensure its “availability” and “accessibility” for mass vaccination on a sustainable basis.
Establishment of such indigenous technology platform will not only empower India to handle the COVID-19 pandemic but also ensure the preparedness for future outbreaks’ said Dr Renu Swarup, Secretary, Department of Biotechnology and Chairperson BIRAC.
The vaccine-like Pfizer and Moderna that claims over 90 per cent efficacy, uses the mRNA model.