India's first homegrown mRNA COVID vaccine coming soon; here are details

What’s making news?

India is poised to have its first mRNA COVID-19 vaccine, which is being viewed as a game changer in the health industry. Last week, the Subject Expert Committee (SEC)of India’s drug regulator at a meeting recommended the Emergency Use Authorisation (EUA) of the country’s first mRNA COVID-19 vaccine.

The SEC found the data submitted on the vaccine by the Pune-based Gennova Pharmaceuticals satisfactory. This means that the Drugs Controller General of India (DCGI) is expected to approve EUA for their mRNA vaccine any time soon, said media reports quoting sources.

Why is mRNA a game changer?

Unlike other vaccines, which has to be stored at sub-zero temperatures, this mRNA vaccine can be stored between 2 and 8 degree celsius. This means that it can be stored at the temperature of a standard medical refrigerator, which will help to make its roll-out in India easy. The mRNA is considered to be a fourth generation vaccine platform.

What went into making Indian version of mRNA COVID-19 vaccine?

Known as GEMCOVAC-19, this is India’s indigenously manufactured mRNA vaccine. The company has conducted phase two and three trials on 4,000 participants to evaluate the vaccine’s safety, immunogenicity and tolerability. Gennova had in April submitted interim data on the indigenously developed vaccine to the drug regulator. After that, the Central Drugs Standard Control Organisation had sent some more queries to the company, and additional data was submitted again in May.

Scientists, biotechnologists, pharmacists and production personnel at the firm have toiled for over one-and-a-half years to come out with the Indian version of mRNA COVID-19 vaccine. The main aim has been to innovate and ensure the mRNA vaccine can be made affordable and deployable.

Also read: Country’s first indigenous mRNA vaccine candidate gets nod for human trials

What is mRNA?

mRNA is the short form of Messenger RNA, which is a type of RNA found in cells and it is used for the production of proteins. mRNA molecules carry the genetic information needed to make proteins. In short, mRNA vaccines teach our cells how to make a protein that will trigger an immune response inside our bodies.

How mRNA COVID-19 vaccines work?

To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies but that is not the case for mRNA vaccines. mRNA vaccines, instead, 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. That immune response, which produces antibodies, is what helps protect us from getting sick from the germ.

The actual process

Once the mRNA COVID-19 vaccine is injected in the upper arm muscle, the mRNA will enter the muscle cells and use the cells’ machinery to produce the harmless spike protein.

The spike protein is found on the surface of the virus that causes COVID-19. After the protein piece is made, our cells break down the mRNA and remove it. Next, our cells display the spike protein piece on their surface. Our immune system recognises that the protein does not belong there. This triggers our immune system to produce antibodies and activate other immune cells to fight off what it thinks is an infection. This is what the body does if you get sick with COVID-19.

At the end of the process, our bodies have learned how to help protect against future infection with the virus that causes COVID-19. Any side effects from getting the vaccine are normal signs that the body is building protection.

Also read: Moderna’s mRNA COVID vaccines will reach India this week

More about mRNA

mRNA vaccines do not use any live virus.

mRNA vaccines cannot cause infection with the virus that causes COVID-19 or other viruses.

The mRNA and the spike protein do not last long in the body.

Our cells break down mRNA from these vaccines and get rid of it within a few days after vaccination.

Scientists estimate that the spike protein, like other proteins our bodies create, may stay in the body up to a few weeks.

Can mRNA platform be used for any other vaccine?

mRNA platform is likely to be useful for developing vaccines for other diseases like malaria, dengue and TB as well. Gennova is also developing an Omicron-specific vaccine on its mRNA platform.

Researchers have been studying and working with mRNA vaccines for decades. mRNA vaccines have been studied before for flu, Zika, rabies, and cytomegalovirus (CMV). As soon as the necessary information about the virus that causes COVID-19 was available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine.

Future mRNA vaccine technology may allow for one vaccine to provide protection against multiple diseases, thus decreasing the number of shots needed for protection against common vaccine-preventable diseases.