Country’s first mRNA vaccine candidate by Gennova gets nod for conducting human trials: DBT

New Delhi: The country’s first indigenous mRNA vaccine candidate developed by Gennova, Pune has received approval from drug regulators to initiate Phase 1/2 human clinical trials, the Department of Biotechnology said on Friday.

The novel mRNA vaccine candidate, HGCO19, is supported with seed grant under the Ind-CEPI mission of the Department of Biotechnology.

The mRNA vaccines do not use the conventional model to produce an immune response. Instead, they carry 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 recognised, thereby, making the body mount an immune response against the disease. The mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline, the DBT said.

It is also considered safe as it is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms.

”They are expected to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm. Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, for example, 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 DBT added.

Gennova has completed all preliminary work and should be initiating the Phase 1/2 human clinical trial soon since the approval from the DCGI office has been received, the DBT said.

”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,” Renu Swarup, Secretary, Department of Biotechnology said.

Five vaccine candidates are under different phases of clinical trials in India, with the Serum Institute of India conducting phase 3 trial of the Oxford-Astrazeneca COVID-19 vaccine. The indigenously developed vaccine by Bharat Biotech in collaboration with the ICMR has already started the phase 3 clinical trial.

Another indigenously-developed vaccine by Zydus Cadila has also completed phase 2 clinical trials in the country. Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) have also announced the start of adaptive phase 2 and 3 clinical trials for COVID-19 vaccine Sputnik V in India.

Also, Biological E Limited has started early phase 1 and 2 human trials of its COVID-19 vaccine candidate.

Gennova, in collaboration with HDT Biotech Corporation, Seattle, USA, has worked together to develop an mRNA vaccine candidate. HGCO19 has already demonstrated safety, immunogenicity, neutralisation antibody activity in animals. 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, the DBT said.

Gennova’s vaccine candidate uses the most prominent mutant of spike protein (D614G) and also uses the self-amplifying mRNA platform, which gives the advantage of a low dosing regimen compared with the non-replicating mRNA or traditional vaccines.

HGCO19 uses the adsorption chemistry so that the mRNA is attached on the surface of the nano-lipid carrier to enhance the release kinetics of the mRNA within the cells compared to the encapsulation chemistry. HGCO19 is stable at 2 to 8 degrees Celsius for two months.

The Department of Biotechnology is implementing the IndCEPImission ‘India Centric Epidemic Preparedness through Rapid Vaccine Development: Supporting Indian Vaccine Development’ which is aligned with the Global Initiative of CEPI and aims to strengthen the development of vaccines and associated competencies/technologies for the diseases of epidemic potential in India.

The Ind-CEPI mission of DBT is implemented by its PSU, Biotechnology Industry Research Assistance Council (BIRAC).