DCGI granted 'emergency use authorization' for GEMCOVAC-OM, developed by Gennova Biopharmaceuticals with DBT.
Published Jun 20, 2023 | 7:09 PM ⚊ Updated Jun 20, 2023 | 7:09 PM
mRNA vaccines use mRNA created in a laboratory to teach our cells how to make a protein that triggers an immune response. (Supplied)
The Drug Control General of India (DCGI) granted Emergency Use Authorization (EUA) for GEMCOVAC-OM, the first indigenous mRNA-based booster vaccine developed specifically for the Omicron variant of the Coronavirus.
Manufactured by Gennova Biopharmaceuticals of Pune, in collaboration with the Department of Biotechnology (DBT), the vaccine has received restricted emergency use approval for individuals aged 18 and above.
GEMCOVAC-19, the precursor to GEMCOVAC-OM, was developed by Gennova Biopharmaceuticals with support from the Mission Covid Suraksha programme, implemented by the DBT’s dedicated mission implementation unit Biotechnology Industry Research Assistance Council (BIRAC).
The Department of Biotechnology aids Gennova’s mRNA-based vaccine manufacturing, from proof of concept to phase 1 clinical trials of the prototype vaccine targetting the Wuhan strain.
All this support facilitated the clinical development and scaling up of the prototype vaccine GEMCOVAC-19, which received EUA status on 29 June 2022.
The platform technology developed during this process was utilised to create an Omicron-specific booster vaccine for Covid-19 — GEMCOVAC-OM — which finally got approval from the DGCI on Tuesday, 20 June.
How mRNA vaccines work. (Aurora Biomed)
To trigger an immune response, many vaccines put a weakened or inactivated version of the virus into our bodies, just like Covaxin and Covishield.
mRNA vaccines use mRNA created in a laboratory to teach our cells how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies. GEMCOVAC is a mRNA-based vaccine using a spike protein, a small piece of a protein found on the outer membrane of the Coronavirus.
Using this mRNA blueprint, cells produce the viral protein. As part of a normal immune response, the immune system recognises that the protein is foreign and produces specialised proteins called antibodies. Antibodies help protect the body against infection by recognising individual viruses and marking the pathogens for destruction.
Once produced, antibodies remain in the body, even after the body has rid itself of the pathogen, so that the immune system can quickly respond if exposed again.
The first two vaccines that were made available for use in the United States — Pfizer-BioNTech and Moderna vaccines — were based on mRNA technology.
However, the Indian mRNA vaccines have an edge over its international competitors as it does not require sub-zero temperatures for its storage. GEMCOVAC-19 is not stored in liquid form. This mRNA vaccine developed is available in the lyophilised (freeze-dried) or powdered form. The vaccine can be reconstituted using a diluent before administration.
Like the prototype vaccine, GEMCOVAC-OM too is a thermostable vaccine that does not require ultra-cold chain infrastructure used for other approved mRNA-based vaccines, making it easy for deployment pan-India.
It is delivered intradermally using a needle-free injection device system. When administered intradermally in participants as a booster, it generated significantly higher immune responses. The clinical outcome demonstrated the need for variant-specific vaccines for desired immune response.
Dr Jitendra Singh, Minister of State (Independent Charge) of Science and Technology, in a statement, said, “Infrastructure to deploy vaccines in India at 2‑8°C exist today and this innovation is tailored for the existing established supply-chain Infrastructure. This vaccine does not need ultra-low temperature conditions for transport and storage.”
Speaking on the development, CEO of Gennova Biopharmaceuticals, Dr Sanjay Singh, said, “India has now developed not one but two mRNA vaccines against Covid-19 using this rapid disease-agnostic platform technology. I am proud that my team has worked tirelessly over the last two years to develop the nation’s first mRNA vaccine.”
“mRNA vaccines help in generating a strong immunity. It not only generates antibodies to fight the virus, but also produces immune cells that help in attacking the virus doubly,” Dr Rakesh Mishra, former Director of CSIR-Centre for Cellular and Molecular Biology (CCMB), Hyderabad, told South First.
The mRNA turnaround time reduces the entire vaccine formulation and development stage drastically. (Gennova)
Dr Mishra added that the efficacy of mRNA is also higher than other vaccines. “It can be more effective against mutant variants of the Coronavirus,” said Dr Mishra.
mRNA vaccine technology can be tweaked in case of emerging variants. According to the statement by Gennova Biopharmaceuticals, they designed the mRNA vaccine against the Omicron variant within 60 days.
“Multiple mRNAs can be encoded in a single vaccine, which might help in targeting antigens produced from different variants,” Dr Vijay Morampudi, a professor at University of Hyderabad, told South First.
As the price of the vaccine is yet to be determined and the vaccine availability is yet to be disclosed, there are some apprehensions regarding the rolling out of the vaccine in the country.
“As we have seen with the Pfizer and Moderna vaccines, their prices are quite high. Also, as most of the population in the country is already vaccinated with other vaccines and there is also non-availability of studies regarding the mixing of GEMCOVAC-OM with other vaccines, it’s unsure when it will be available to people,” noted Dr Mishra.
