India’s first homegrown mRNA based vaccine, developed by Pune-based Gennova Biopharmaceuticals, is in its final stages of getting the nod from Drug Controller General of India (DGCI) for emergency use authorization. The pharma firm has recently completed stage 2/3 trials and has submitted efficacy and other data to the national regulatory authority. Gennova also plans to start trials for the paediatric population soon.

The Phase II and Phase III study protocols for HGC019 got DGCI nod in August and the firm has submitted interim clinical data of Phase I and Phase II study. The Phase III trials were conducted among 4000 participants held across DBT-ICMR clinical trial network sites. The human clinical trial data will be studied and reviewed after which DGCI will give final nod and the vaccines will be rolled out for the general public for administration.

What is mRNA vaccine?

The mRNA vaccine uses genetic material from disease-causing virus and makes the body form an immune response against the virus in the body. The vaccinations have been at the helm of Covid-19 vaccination programmes for some time now. They teach the cells how to make proteins that trigger immune response. The muscle creates protein pieces and displays them on the cell surface to create antibodies for future contraction of the Covid infection. Both the Pfizer-BioNTech and the Moderna COVID-19 vaccines use mRNA.

Paediatric vaccine trial –

Selecting participants for Paediatric vaccine trials is challenging as many adolescents can be infected and asymptomatic during the trials and hence whether or not to include criteria like testing for antibodies against covid will be decided upon. Participants have to present a negative RT-PCR report. Sr D Y Patil Medical College has been identified for clinical trials of children , According to Dr Sharad Agharkhedkar, phase 2 trial is likely to enrol 200 participants with 100 each in age groups 12 to 17 years and 5 to 11 years. There will be about 10-15 trial sites. The site is awaiting the approval for DGCI to finalise the trial design protocol for the paediatric age group, informed Dr Singh.

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