Covid-19: India's mRNA vaccine receives approval for human trial

The Centre has approved the human safety trials of a homegrown Covid-19 vaccine that uses the same technology as the Moderna and Pfizer shots but promises to remain stable at 2 to 8 degrees Celsius, making it more suitable for use in India.

The Indian drug regulator, Central Drugs Standard Control Organisation, permitted Pune-based Gennova Biopharmaceuticals to conduct a phase-1/2 clinical trial of its mRNA vaccine on Wednesday with the condition that on completion of the first phase examining the vaccine’s safety, the company would submit its data for a review before starting the phase-2 to evaluate the vaccine’s immune response.

The permission was granted on the basis of animal toxicity studies. While the first phase of the Indian trial would be carried out at two hospitals in Pune and Aurangabad, the vaccine would also undergo clinical trials in the USA.

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Developed by the Gennova Biopharmaceuticals in collaboration with the Seattle based HDT Bio Corp, the mRNA-based vaccine received approximately Rs 20 crore funding support from the Department of Biotechnology and $ 8.2 million (nearly Rs 60 crore) grant from the US National Institute of Allergy and Infectious Diseases for clinical testing.

“DBT’s role goes beyond seed funding. Using our vaccine expert group under the Indo-US Vaccine Action Programme, we gave them technical strength and scientific guidance. It's India’s first mRNA based vaccine, which if proven successful would be very good for us as it can be stored at 2-8 degrees Celsius temperature,” Renu Swarup, DBT Secretary told DH.

“This is one of the projects receiving funds under the Rs 900 crore Covid-Suraksha Mission. We are supporting 12-13 vaccine candidates.”

Though mRNA vaccines are new technology, they have several advantages over conventional vaccines including a faster pace of development as they don’t need any bacterial host to grow. “The vaccine is easily scalable and cost-effective,” she said.

Read: Data from Pfizer/BioNTech, Moderna for Covid-19 vaccines 'very robust': EMA

Thermal stability is an added advantage for the Gennova-HDT product unlike the Pfizer-BioNTech and Moderna shots that are also based on the same technology but have ultra-low cooling requirements for storage and transportation.

The mRNA platform was originally developed to create personalized cancer vaccines. When the pandemic hit the world, the two companies repurposed the platform to create a vaccine against the SARS-Cov-2, using the same approach, which the virus takes to invade the body.

The vaccine candidate HGCO19 contains a short, synthetic version of a genetic material (mRNA) that mimics the spike protein of the novel coronavirus, SARS-CoV-2.

When the vaccine is injected, the mRNA is taken to muscle cells where it instructs the cells to make numerous copies of the mRNA mimicking the spike protein. Other immune cells would then take on the spike proteins and in the process learn to identify the coronavirus and protect the body if the person were ever to be actually infected.