FAQ | DCGI Approves India's First Indigenous mRNA COVID Vaccine - What To Know

Gennova Pharmaceuticals and AIC-CCMB are leading the charge in mRNA vaccines against COVID-19 in India.

This is India's first indigenous mRNA vaccine against SARS-CoV-2 and COVID-19.

(Photo: iStock)

The Drugs Controller General of India (DCGI) approved the emergency use of India's first mRNA COVID vaccine for those 18 years and above, on Tuesday, 28 June.

The mRNA vaccine, called Gemcovac-19, is being developed by Gennova Biopharmaceuticals in Pune.

The vaccine is expected to be available in the private market by July 2022.

Apart from this, The Council of Scientific and Industrial Research (CSIR), the Atal Incubation Centre and the Centre for Cellular and Molecular Biology (CCMB) had in May 2022 also pitched an mRNA vaccine, pegged as India's first ever indigenous mRNA vaccine to fight SARS-CoV-2 and COVID-19.

Here's everything you need to know about India's mRNA COVID-19 vaccines.

What is an mRNA vaccine?

An mRNA (Messenger Ribonucleic Acid) vaccine is modified RNA from an organism that's introduced to a patient to induce immunity against that specific virus. It uses protein from the virus to allow the human body to learn how to fight the virus.

How does an mRNA vaccine work?

mRNA vaccines work by conditioning the immune system to fight the virus before even being infected. Once introduced into the human body, mRNA vaccines activate a kind of specific response and a specific set of cells that help the body create stronger antibodies.

When will India's indigenous mRNA vaccine be available to the public?

Reports state that approximately 70 lakh doses of Gennova's mRNA vaccine have already been cleared and are expected to be available to people from July 2022.

The vaccine will be available to the private market. As far as inclusion in the government COVID-19 vaccination programme, it remains to be seen if this will be done.

The vaccine being developed by AIC-CCMB in Hyderabad is currently pending animal challenge studies and may report results soon, as per Dr. N Madhusudan Rao, CEO of Atal Incubation Centre.

Who's leading the charge on the vaccine development?

Two teams are leading the mRNA vaccine race in India right now - The first is Gennova Pharmaceuticals, which received DCGI approval on Tuesday, 29 June.

The second vaccine formulation is being led by a team of researchers at Atal Incubation Centre-CCMB (AIC-CCMB) in tandem with the Council Of Scientific And Industrial Research (CSIR).

Has the vaccine been tested?

Gennova Pharmaceuticals submitted interim trial results in April 2022, and sought Emergency Use Authorization in June 2022. Gennova's website also states that they've tested the vaccine on over 4,000 candidates.

Speaking about AIC-CCMB's vaccine, Dr. Rajesh Iyer, a scientist on the project told India Today that the vaccine's lab tests on mice showed a robust immune system response against the SARS-CoV-2 spike protein.

This was observed after two doses of the vaccine. Further, the study showed that the antibodies generated by the vaccine were more than 90 percent more effective in preventing the binding of the virus to the human ACE 2 receptor.

What are the benefits of this vaccine over others?

Gennova's vaccine won't need to be stored at sub-zero temperatures, which could make its roll-out much easier in India. While most vaccines need to be stored at temperatures below zero, Gennova's vaccine is expected to store well at 2-8 degrees Celsius.

According to the AIC-CCMB team, the indigenous nature of their mRNA vaccine along with the pre-clinical trial results shows that the vaccine tech can be replicated for other infectious diseases.

mRNA technology also allows for quick turnaround and large-scale replication. This means the technology and process could be used to combat not just COVID-19 but also other diseases like tuberculosis, malaria, and dengue.