Pune, Feb. 15: PHASE 2/3 human trials of the country’s first homegrown mRNA vaccine developed by Pune-based Gennova Biopharmaceuticals have been completed and the firm is in the process of submitting data to the national regulatory authority. Plans are also afoot to test the vaccine in the paediatric population initially in a phase 2 trial.

The Drug Controller General of India, had approved Phase II and Phase III study protocols for HGCO19, India’s first mRNA-based COVID-19 vaccine, developed by Gennova Biopharmaceuticals Limited (“Gennova”) in August last year. The firm had submitted the interim clinical data of the Phase 1 study then to the Central Drugs Standard Control Organisation – the Government of India’s national regulatory authority.

“Phase II and III trials have been completed. We have submitted and presented Phase II data and are in the process of submission of Phase III trial data that was conducted among 4,000 participants,” Dr Sanjay Singh, CEO of Gennova Biopharmaceuticals, told. The study was conducted across DBT-ICMR clinical trial network sites.

According to the Indian Media, Recently, Dr V K Paul, member (health), NITI Aayog had said that the mRNA Covid-19 vaccine is being tested in adults in clinical trials and the government hopes to use it someday. Highly placed sources in the Department of Biotechnology (DBT), Government of India, said that human clinical trial data will have to be studied and reviewed following which a roll out will be planned.

mRNA- based vaccines belong to the category of nucleic acid vaccines which use genetic material from the disease causing virus to trigger an immune response against it within the body. Worldwide, these vaccines have been at the helm of Covid-19 vaccination programmes.

Paediatric vaccine trial While scientists seek answers to how safe the vaccine will be in children, the large number of Covid infections may pose a challenge to enroll participants. It is likely that children with the infection have been asymptomatic and hence whether or not to include criteria like testing for antibodies against Covid-19 will be decided upon. However, the participants would require a RT-PCR negative report. In Pune, Dr D Y Patil Medical College and Hospital has been identified as a clinical trial site. According to principal investigator of the trial Dr Sharad Agharkhedkar, initially, the phase 2 trial is likely to enroll an approximate 200 participants with 100 each in the 5-11 and 12-17 age group. According to Dr Shalaka Agharkhedkar, clinical trial consultant, there will be around 10-15 trial sites.

“The trial design protocol for a vaccine trial in the paediatric age group is still under discussion . Once the regulatory approvals are obtained, the trial will commence in a fortnight’s time,” Dr Singh said.