DBT-BIRAC supported Nation’s first mRNA-based vaccine

Last Updated25/08/2021

Gennova Biopharmaceuticals Ltd., the Pune-based biotechnology company submitted the interim clinical data of the Phase I study of India’s first mRNA-based COVID-19 vaccine, to the Central Drugs Standard Control Organisation (CDSCO).
The Vaccine Subject Expert Committee (SEC) reviewed the interim Phase I data and found that the country's first mRNA-based Covid vaccine HGCO19 is safe.
The national drugs regulator also has granted approval to its maker to begin Phase 2/3 trials.

Gennova's mRNA-based COVID-19 vaccine development program was partly funded by the Department of Biotechnology (DBT), Govt. of India under Ind CEPI, in Jun 2020.
Later on, the DBT further supported the program under the Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC.
The company has submitted the proposed Phase II and Phase III study entitled ""A Prospective, Multicentre, Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to Evaluate the Safety, Tolerability, and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects"" which was approved by the office of the DCG(I), CDSCO.
The study will be conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III.
Gennova plans to use the DBT-ICMR clinical trial network sites for this study.

mRNA vaccines are a new type of vaccine which makes use of the messenger RNA molecules that tell the body’s cells what proteins to build to protect against infectious diseases.

Once the mRNA vaccine is inside the muscle cells, the cells use them to make the protein piece.
After the protein piece is made, the cell breaks down the instructions and gets rid of them.
Next, the cell displays the protein piece on its surface.
Our immune systems recognize that the protein doesn’t belong there and begin building an immune response and making antibodies, like what happens in natural infection against COVID-19.
At the end of the process, our bodies have learned how to protect against future infection.

mRNA vaccines do not use the live virus that causes COVID-19.
It is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. Therefore it is relatively safe.
It can be produced faster, cheaper, and in a more standardized fashion which improves responsiveness to outbreaks.
They are highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm.

The DBT, under the Ministry of Science and Technology, promotes and improves biotechnology development in India through its development and implementation in agriculture, healthcare, animal sciences, the environment, and industry.

BIRAC is a not-for-profit Public Sector Enterprise, set up by DBT, Government of India.
It is an Interface Agency to strengthen and empower the emerging biotech enterprises to undertake strategic research and innovation for globally competitive product development to address unmet needs.

It was launched to provide to the Department of Biotechnology (DBT) for the Research & Development of Indian COVID-19 vaccines.
Mission Covid Suraksha entails a grant of Rs 900 crore.
The department of biotechnology will get this grant.
The mission aims at providing end-to-end passage to vaccines — from preclinical stage to manufacturing.
The Centre had announced this package during the third stimulus.
The department supported the development of 10 vaccines, including the Russian Vaccine Sputnik-V.
The aim of the project is to also establish clinical trial sites and strengthen the existing immunoassay laboratories, central laboratories and suitable facilities for animal studies, production facilities and other test facilities to support Covid-19 vaccine development.