India’s homegrown mRNA Covid vaccine: Human trials over; data to be sent to regulator

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.

3 min readPuneFeb 15, 2022 07:35 AM IST

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.(File)

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 Indian Express. The study was conducted across DBT-ICMR clinical trial network sites.

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.

Anuradha Mascarenhas

Anuradha Mascarenhas is a Senior Editor at The Indian Express, based in Pune. With a career spanning three decades, she is one of the most respected voices in Indian journalism regarding healthcare, science and environment and research developments. She also takes a keen interest in covering women's issues . Professional Background Education: A gold medalist in Communication and Journalism from Savitribai Phule Pune University and a Master’s degree in Literature. Author: She authored the biography At The Wheel Of Research, which chronicles the life and work of Dr. Soumya Swaminathan, the former Chief Scientist at the WHO. Key Focus: She combines scientific accuracy with storytelling, translating complex medical research into compelling public and human-interest narratives. Awards and Recognition Anuradha has won several awards including the Press Council of India's national award for excellence in journalism under the gender based reporting category in 2019 and the Laadli Media award (gender sensitivity -2024). A recipient of the Lokmat journalism award (gender category-2022), she was also shortlisted for the RedInk awards for excellence in journalism-2021. Her debut book At The Wheel Of Research, an exclusive biography of Dr Soumya Swaminathan the inaugural chief scientist of World Health Organisation was also nominated in the Popular Choice Category of JK Paper AUTHER awards. She has also secured competitive fellowships including the Laadli Media Fellowship (2022), the Survivors Against TB – New Research in TB Media Fellowship (2023) and is part of the prestigious 2025 India Cohort of the WomenLift Health Leadership Journey.” Recent Notable Articles (Late 2025) 1. Cancer & Specialized Medical Care "Tata Memorial finds way to kill drug-resistant cancer cells" (Nov 26, 2025): Reporting on a breakthrough for triple-negative breast cancer, one of the most aggressive forms of the disease. Discipline, diet and purpose; How a 97-year-old professor defies ageing'' (Nov 15, 2025) Report about Prof Gururaj Mutalik, the first Head of Department at Pune's B J Government Medical College who at 97 credits his longevity to healthy habits and a strong sense of purpose. 2. Environmental Health (The "Breathless Pune" Series) Long-term exposure even to 'moderate' air leads to chronic heart, lung, kidney issues" (Nov 26, 2025): Part of an investigative series highlighting that even "safe" pollution levels are damaging to vital organs. "For every 10 µg/m3 increase in PM2.5 level, there was 6-8% jump in medicine sales" (Nov 23, 2025): Using commercial data to prove the direct link between air quality and respiratory illnesses in Pune. 3. Lifestyle & Wellness News "They didn't let cancer, diabetes and heart disease stop them from travelling" (Dec 22, 2025): A collaborative piece featuring survivors who share practical tips for traveling with chronic conditions. At 17, his BP shot up to 200/120 mmHG; Lancet study flags why child and teen hypertension doubled between 2000 and 2020'' (Nov 12,2025)--A report that focusses on 17-year-old-boy's hypertensive crisis and reflects the rising global trend of high blood pressure among children and adolescents. 4. Scientific Recognition & Infrastructure For promoting sci-comm, gender diversity: IUCAA woman prof highlighted in Nature" (Nov 25, 2025): Covering the global recognition of Indian women scientists in gender studies and physics. Pune researchers find a spiral galaxy like the Milky Way from early universe'' (December 3, 2025)- A report on how Indian researchers discovered a massive galaxy that existed when the universe was just 1.5 billion years old , one of the earliest to have been observed so far. Signature Beat: Health, Science & Women in Leadership Anuradha is known for her COVID-19 reportage, where she was one of the first journalists to provide detailed insights into the Covishield and Covaxin trials. She has a dedicated interest in gender diversity in health and science, often profiling women researchers who are breaking the "leaky pipeline" in STEM fields. Her writing style is scrupulous, often featuring interviews with top-tier scientists and health experts from various institutions. ... Read More

Click here to join Express Pune WhatsApp channel and get a curated list of our stories

Tags:
pune

Loading Recommendations...

May 17: Latest News

Live Blog