Even as the central government is planning to boost COVID vaccine availability through a number of initiatives, it is quietly pushing for speedy development of a home-grown mRNA-based vaccine that has reached the human clinical trials stage. Further funding to the tune of ₹50 crore is likely to be provided for the vaccine being developed by Gennova Biopharmaceuticals, a Pune-based biotechnology company, in collaboration with HDT Biotech Corporation of the US. It is expected that the vaccine under development will also be effective against mutated variants of coronavirus.
Called HGCO-19, the vaccine candidate’s safety, immunogenicity, and neutralisation antibody activity have been demonstrated in rodent and primate models, according to the Ministry of Science & Technology. The neutralising antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19. Gennova is now starting enrolment for human clinical trials and data from the trails will be evaluated to assess its success.
Gennova has completed two pre-clinical toxicity studies according to Drugs and Cosmetics (Ninth Amendment) Rules of 2019, to establish the safety of the vaccine candidate. The project has obtained regulatory clearance from the Review Committee on Genetic Manipulation (RCGM) and office of the Drugs Controller General of India (DCGI), to conduct clinical trials. Following the green signal, Gennova has initiated the process to enrol healthy volunteers from the Phase I/II clinical trials.
Messenger RNA Tech
Instead of the usual technology of using an inactivated virus to trigger immune response in our bodies, messenger RNA vaccines teach our cells to make a protein that triggers immune response. The antibodies generated by the immune response fight the virus in case we get infected. According to officials, mRNA vaccines are considered safer as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms.
Such vaccines are considered to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm.
Moderna and Pfizer vaccines, for example, are based on mRNA technology. China is also said to be working on development of a mRNA vaccine while it has already developed other COVID-19 vaccines that have been put to public use. In the case of flu, zica and rabies too, vaccines based on this technology have been used. Since mRNA vaccines are fully synthetic, they do not require a host for growth. Thus, they can be quickly manufactured inexpensively to ensure their “availability” and “accessibility” for mass vaccination needed for countries like India to acquire herd immunity.
Twin Strategy of Imports and Local Production
Therefore, the government feels development of this vaccine for larger public use would provide another affordable option to vaccinate India’s 130 crore population. Apart from widening the use of Covishield and Covaxin, the government has also recently opened the door for Russia’s Sputnik vaccine, which is going to be imported by Dr Reddy’s Lab in the initial stages and then produced in India. The government has also simplified the procedures for speedy clearance to vaccines that have been approved by the regulators of the US, European Union, the UK and Japan.
While imported vaccines could be more expensive than Covishield and Covaxin, whose prices are being controlled by the government, HGCO-19 could provide another cheaper alternative for India, apart from meeting huge export demand. The mRNA vaccine is part of the ‘Vaccine Discovery Programme’ supported by the central government’s Department of Biotechnology under the ‘Mission COVID Suraksha’ programme.
Support Since Last Year
According to the Department of Biotechnology (DBT), additional funding has been approved for clinical studies of HGCO-19 that is being described as the country’s ‘first of its kind’ mRNA-based vaccine. DBT has been hand-holding the Gennova project right from the start with seed-funding. The department has also facilitated establishment of Gennova’s next-generation vaccine manufacturing platform with its full support. Officials are tightlipped on the amount of funding that will be provided to the company, claiming that funds will not be a constraint but will be released in phases according to government norms and progress of the project.
Gennova Biopharmaceuticals is a biotechnology company engaged in research, development, production, and commercialisation of biotherapeutics. Funding for the project was approved by the biotechnology department’s dedicated Mission Implementation Unit at Biotechnology Industry Research Assistance Council (BIRAC) after multiple rounds of evaluation. When applications were invited under Mission COVID Suraksha for development of vaccines to fight the highly infectious coronavirus, Gennova had come up with its mRNA-based project.
Establishment of a mRNA-based platform will empower India to handle the COVID-19 pandemic more effectively and ensure preparedness for any future pandemic or endemic stage that will follow due to factors like mutation in the virus, unvaccinated low-risk population, and newborns, the Ministry feels.
Effective Against Mutants Too
According to Dr Renu Swarup, secretary in the Department of Biotechnology, and chairperson of BIRAC, the Gennova project has been supported since last year. “At the onset of COVID-19, DBT backed many vaccine development programmes, including the mRNA-based vaccine. A year back, this was a new technology and never used for vaccine manufacturing in India. However, believing in the potential of this technology, DBT provided seed funding to Gennova to develop this technology platform amenable to scale-up and production. We are very proud that India’s first mRNA-based vaccine is going to the clinics,” the secretary was quoted as saying in a statement issued by the ministry.
“We conducted all required safety assessments of the HGCO-19 as per well-defined norms and regulations before the start of the human clinical trial designed to establish the safety and efficacy of the vaccine,” Dr Sanjay Singh, CEO of Gennova, was quoted by the statement. “Today, the problem of the SARS-CoV2 illness and the associated appearance of new variants made this disease a moving target. We believe the mRNA-based cutting-edge technology will play an important role in evolving effective solutions,” he said.