mRNA BASED VACCINES

mRNA is used as a bio therapeutic, where it gets translated in the cells of the human body to the corresponding protein antigen it codes for, against which antibodies can be developed.

The use of mRNA as a therapeutic agent was made possible by the development of various delivery agents and modifications to the mRNA which increased its stability, efficacy, delivery efficiency and immunogenicity.

mRNA can be used to create practically any protein in the body: antigen against which antibodies can be developed, growth factors, enzymes for rare diseases, host-specific proteins, etc.

The establishment of the ‘mRNA-based platform technology’ could be an important tool for developing variant- proof, safe and effective vaccines. mRNA vaccines do not contain live virus and carry no risk of causing disease in the vaccinated person thus making it suitable for people with compromised immune systems.

mRNA-based vaccines are the ideal choice because of their rapid development and production timeline. mRNA vaccines are considered safe as mRNA is non infectious, non integrating in nature, and is degraded by standard cellular mechanisms. They are highly efficacious because of their inherent capability of being translated into proteins. 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 a cost effective manner under cGMP conditions to ensure their “availability” and “accessibility” for mass vaccination on a sustainable basis. These vaccines are safe as mRNA is non-infectious, non- integrating in nature, and degraded by normal cellular mechanisms.

mRNA RND Cycle

GEMCOVAC®

Gennova has developed two mRNA-based vaccine against COVID-19, GEMCOVAC®-19 and GEMCOVAC®-OM.

GEMCOVAC®-OM has recently received Emergency Use Authorization (EUA) as a single dose booster specifically targeting the Omicron strain. Notably, individuals who have previously received primary immunization with either COVISHIELD™ or COVAXIN® can safely receive GEMCOVAC®-OM as a booster after a four-month interval.

The GEMCOVAC® vaccines overcome the limitations associated with the currently approved mRNA vaccines.

The currently approved mRNA vaccines have certain inherent limitations like:

    • Ultra-low temperature logistics
    • Ease of Manufacturing
    • Supply of raw materials
    • Scalability
    • Technology transfer

GEMCOVAC®  is stable at 2 – 8 °C and can be considered superior in terms of deployability in India and other developing nations (especially LMICs) compared to other approved mRNA vaccines. In GEMCOVAC®, the mRNA is adsorbed on the surface of the nano-lipid emulsion (as opposed to it being entrapped in other mRNA vaccines using NLPs), thereby easing manufacturability and minimizing losses.

This also makes the process scalable and amenable for technology transfer – a must for the democratization of  the mRNA-based technology globally to eliminate the inequitable vaccine distribution globally.

In addition to the obvious application to infectious diseases, mRNA-based vaccines have the potential for multiple administrations in patients with low intrinsic immunity, thereby opening up bright prospects for developing novel therapeutics. Creating such an unprecedented ‘disease agnostic mRNA-based technology platform’ empowers the world to be ready for future pandemics.

NEWS UPDATES


GEMCOVAC-19, India’s first mRNA Covid-19 vaccine, and how it scores over Pfizer, Moderna

Apart from being indigenously developed, the vaccine is available in powdered form without the need to be stored at sub-zero temperatures, making it easy to transport to remote areas…Read more

MoneyControl • JUNE 29, 2022, 02:38 PM IST


Combinative workflow for mRNA vaccine development

Biochem Biophys Rep. 2024 Jun 28:39:101766.
doi: 10.1016/j.bbrep.2024.101766.

https://www.sciencedirect.com/science/article/pii/S2405580824001304?via%3Dihub

 


An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial

Nat Med. 2024 Apr 18; 30, 1363–1372.
doi: 10.1038/s41591-024-02955-2.

https://www.nature.com/articles/s41591-024-02955-2#citeas

 


Leveraging the immunoinformatics approach for designing the SARS-CoV-2 omicron-specific antigenic cassette of mRNA vaccine

Vaccine. 2024 Mar 7; 42(7):1630-1647.
doi: 10.1016/j.vaccine.2024.01.087.

https://www.sciencedirect.com/science/article/abs/pii/S0264410X24001117?via%3Dihub


Evaluation of self-amplifying mRNA platform for protein expression and genetic stability: Implication for mRNA therapies

Biochem Biophys Res Commun. 2023 Nov 5; 680: 108-118.
doi: 10.1016/j.bbrc.2023.09.016.

https://www.sciencedirect.com/science/article/abs/pii/S0006291X2301046X?via%3Dihub