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

The country’s first indigenous mRNA vaccine candidate developed by Pune-based Gennova has received approval from drug regulators to initiate Phase 1/2 human clinical trials, the Department of Biotechnology said on Friday.

The novel mRNA vaccine candidate, HGCO19, is supported with seed grant under the Ind-CEPI mission of the Department of Biotechnology. mRNA vaccines do not use the conventional model to produce immune response.  Instead, they carry the molecular instructions to make the protein in the body through a synthetic RNA of the virus.  

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The host body uses this to produce the viral protein that is recognised, thereby making the body mount an immune response against the disease. 

The Pfizer COVID vaccine, which is the first to get emergency use authorisation from a western country, the UK, is based on mRNA. The other developed by Moderna, which has also applied for emergency use authorisation in the US, is also an mRNA vaccine. Both Pfizer and Moderna have reported that their vaccines have about 95 per cent efficacy.    

An mRNA vaccine is safe because it is “non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms,” the government said.

Currently, the vaccine candidates developed by Oxford-AstraZeneca and Bharat Biotech are in advanced Phase 3 trials in India. Beside, the Russian made Sputnik V will also undergo Phase 3 trials in India. 

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The Pune-based Serum Institute of India, which is conducting the trials of the Oxford-AstraZeneca vaccine, and Bharat Boitech have applied to the government for emergency use authorisation of their respective vaccines. However, an expert panel has sought more data from the companies to proceed with their applications.    

(With agency inputs)