Explained: How India’s first mRNA vaccine for Covid-19 was created

The country’s first homemade mRNA Covid-19 vaccine – GEMCOVAC-19 – was developed at Gennova biopharmaceutical company in Pune Obtained the “Emergency Restricted Use” gesture For the age group 18 and over. Since mRNA vaccines are required to be kept at sub-zero temperatures, it has been a huge task for Gennova scientists to develop a thermostable Covid-19 mRNA vaccine. Scientists had to innovate to suit local needs to make it affordable and deployable. The new vaccine can now be stored at a standard medical refrigerator temperature.

mRNA platform

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

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.

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

But these vaccines must be stored at sub-zero temperatures because mRNA is fragile and easy to break down.

Heat Stable Vaccine

“Unlike the West, where the vaccine must be stored at sub-zero temperatures, the challenge in India was the ability to store the vaccine between 2-8 degrees Celsius. We had to innovate to suit our local needs in terms of what was affordable and deployable. It can now be stored GEMCOVAC-19 at standard medical refrigerator temperature,” says Dr. Sanjay Singh, CEO of Gennova Biopharmaceuticals.

Conversion from inoculum to liquid form to powder is through the freeze-drying process – a process in which water is removed from the product after it has been frozen and placed under a vacuum allowing the ice to convert directly from solid to vapor without going through a liquid phase.

However, simply removing the water by freezing the mRNA vaccine does not work. Therefore, the ambient pressure must be adjusted and then kept stable to ensure that the inoculum properties are the same as they were before Lyophilisation. To achieve this, the key was to add an external agent that would keep it stable at a certain critical concentration under lyophilized conditions. The freeze-drying technology is not new, but the freeze-dried mRNA vaccine is unique.

“We conducted hundreds of experiments before arriving at the correct formulation and condition to ensure a heat-stable mRNA vaccine,” said Dr. Singh.

Trials and Safety

Freeze-drying of large and unstable mRNA with nanoparticles was a daunting challenge. Nevertheless, Genova invested countless working hours hoping to freeze-dry the mRNA vaccine in a single vial within a year. This heat-resistant vaccine has been rigorously tested in various animal models to ensure its safety and immunogenicity before entering human clinical trials. Data from the Phase 1 and 2 trial were submitted across 480 participants earlier, and then data from the Phase 3 trial across 4,000 participants was submitted to the Central Drug Standards Control Organization (CDSCO). During the Phase 3 trials, 3,000 participants were given the mRNA Covid-19 vaccine and 1,000 were given Covishield.

According to Gennova officials, trial data showed the vaccine to be safe and well-tolerated. Immunosuppression measured 2 weeks after the dose showed that GEMCOVAC-19 is not inferior to Covishield.

The two-dose vaccine should be administered by intramuscular injection, at an interval of 28 days.

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Fight the emerging variables

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

“An epidemic-ready platform technology has been created that can be used to rapidly develop a vaccine if a variant of concern arises due to the rapid mutation of SARS-CoV-2 virus. Clinical trials should be conducted to confirm the efficacy of GEMCOVAC-19 against Omicron and its sub variants,” said Dr. Singh.

He added, “The learning curve has been steep not only in terms of production but also in conducting clinical trials. Approval of the first mRNA vaccine in the country will pave the way for the development of new vaccines from specific mRNA vaccines that can be used as boosters in the future. It was absolutely necessary to demonstrate the safety and immunogenicity of the technology The new vaccine platform in the Indian population”.

ready to publish

Gennova already has a license to manufacture and sell from CDSCO. “Gennova has produced 70 lakh doses with risk… Now that we have received the EUA we can ship the items immediately after all the formalities are completed. The current production capacity is around 40-50 doses per month which will be upgraded to 2-3,” said Dr. Singh. fold soon.

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