Explained: How Pune Based Drugs Manufacturer Developed India¡¯s First mRNA Vaccine for Covid-19

Vaccines help prevent infection by preparing the body to fight foreign invaders (such as bacteria, viruses, or other pathogens). All vaccines introduce into the body a harmless piece of a particular bacteria or virus, triggering an immune response. Most vaccines contain a weakened or dead bacteria or virus. However, scientists have developed a new type of vaccine that uses a molecule called messenger RNA (mRNA) rather than part of an actual bacteria or virus.

In cells, mRNA uses the information in genes to create a blueprint for making proteins. Once cells finish making a protein, they quickly break down the mRNA. mRNA from vaccines does not enter the nucleus and does not alter DNA.

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The rollout of Gemcovac-19, the first home-grown mRNA vaccine against Covid-19 in India and the third in the world, will kick off in the domestic and international markets soon.

It has been approved for emergency use by the Drug Controller General of India (DCGI) on Tuesday. The vaccine can be used for people who are 18 years and above. The vaccine has been developed by a Pune-based drugs manufacturer, Gennova Biopharmaceuticals.

How mRNA was developed?

As the Covid-19 pandemic spread, an mRNA vaccine candidate was the first to enter human trials globally. The first two vaccines that were made available for use in the US were based on mRNA technology.

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Unlike vaccines that put a weakened or inactivated virus in your body to activate an immune response, these two Covid-19 vaccines (Pfizer-BioNTech and Moderna) used messenger RNA or mRNA to deliver a message to your immune system, The Indian Express reported.

Basically, the technology uses genetically engineered mRNA to instruct cells to make the S-protein found on the surface of the Covid-19 virus. According to reports from US-based Mayo Clinic, after vaccination, the muscle cells begin making S-protein pieces and displaying them on cell surfaces. This causes the body to create antibodies.

Thermostable vaccine

¡°Unlike in the West, where the vaccine has to be stored at sub-zero temperatures, the challenge in India was to be able to store the vaccine between 2-8 degree Celsius. We had to innovate to suit our local needs as to what is affordable and deployable. GEMCOVAC-19 can now be stored at the temperature of a standard medical refrigerator,¡± Dr Sanjay Singh, CEO of Gennova Biopharmaceuticals told The Indian Express.

The conversion from liquid to powder form of the vaccine takes place via Lyophilisation ¡ª this is freeze-drying, a process where the water is removed from the product after it is frozen and placed under a vacuum allowing the ice to change directly from solid to vapor without passing through a liquid phase.

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However, just removing water by Lyophilisation of the mRNA vaccine does not work. So, the surrounding pressure has to be tweaked and then kept stable to ensure the characteristics of the vaccine are the same as before Lyophilisation. For this to be achieved, the key was to add an external agent which at a certain critical concentration keeps it stable under lyophilized conditions. The Lyophilisation technology is not new, but a lyophilized mRNA vaccine is unique.

¡°We performed hundreds of trials before arriving at the right formulation and right condition to ensure a heat-stable mRNA vaccine,¡± Dr Singh said.

Fight against emerging variants

For the first time, the mRNA platform has been used to develop a Covid-19 vaccine in India. This total process may have taken one-and-a-half years, but for Dr. Singh, a biochemist who had worked on malaria vaccines at the US-based National Institutes of Health, and the team, designing an mRNA vaccine against the Omicron variant barely took 60 days.

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Notably, this technology platform provides flexibility to quickly tweak the vaccine for any existing or emerging variants of the virus.

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