The company has submitted the Phase 2 trial data for its mRNA vaccine candidate to India’s Central Drugs Standard Control Organisation (CDSCO)
Gennova Biopharmaceuticals, a biotechnology company based in Pune, India, is reportedly developing an mRNA Covid-19 vaccine candidate to precisely protect from Omicron variant.
According to Reuters report, the Omicron-specific vaccine candidate may be available within few months, and might need a small clinical trial in India prior to its commercialisation.
The company has submitted the Phase 2 trial data for its original mRNA vaccine candidate to India’s Central Drugs Standard Control Organisation (CDSCO).
Gennova Biopharmaceuticals spokesperson told Reuters: “The Omicron-specific variant of the vaccine is under development and will be ready for human clinical trials, subject to regulatory approvals. We will keep you posted.”
In August last year, the company has submitted Phase 1 interim clinical data to the CDSCO the Government of India’s National Regulatory Authority (NRA).
The subject expert committee (SEC) on the Covid-19 vaccines reviewed the data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study.
Gennova’s mRNA-based Covid-19 vaccine programme was partly funded by the government of India’s Department of Biotechnology (DBT).
The DBT further supported the programme under the ‘Mission COVID Suraksha-The Indian Covid-19 Vaccine Development Mission’, executed by Biotechnology Industry Research Assistance Council (BIRAC), a non-for-profit public sector enterprise set up by the DBT.
If granted emergency-use approval, it would become the India’s first mRNA Covid-19 vaccine, similar to the candidates developed by Pfizer and Moderna.
Last week, Pfizer announced its plans to roll out a redesigned Covid-19 vaccine, which specifically targets the Omicron variant, in March this year.
Gennova is a biotechnology company focused on research, development, production, and commercialisation of biotherapeutics to address life-threatening diseases.