India's first mRNA vaccine may be effective against Omicron, human trials to begin soon
Amid the latest nationwide surge in the coronavirus disease (Covid-19), driven by the highly transmissible Omicron variant, India's first mRNA (messenger RNA) vaccine is set to begin its human trials soon.
Officials familiar with the development told news agency ANI trials are expected to begin in February. Pune-based Gennova Biopharmaceuticals has submitted phase II data of the mRNA vaccine and also completed recruitment for the phase III data, they added.
The officials said the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) is likely to review the data soon. The mRNA vaccine has also been developed for the Omicron variant, and it will soon be tested on humans for efficacy and immunogenicity.
What is the name of this mRNA vaccine?
In September last year, Gennova had issued a press statement, providing an update about the vaccine trials. The pharmaceuticals company had said the DCGI had approved in August that year the phase II and phase III study protocols for India's first mRNA-based Covid-19 vaccine, developed by Gennova Biopharmaceuticals Limited.
The name of the vaccine is HGCO19, it said, adding that Gennova had submitted the interim clinical data of the phase I study to the Central Drugs Standard Control Organisation (CDSCO), India's national regulatory authority.
Early studies found vaccine ‘safe, tolerable’
The Gennova press statement said the vaccine subject expert committee had reviewed the interim phase I data and found that HGCO19 was “safe, tolerable, and immunogenic” in the participants of the study.
Where are the trials being held?
The company said the study is being conducted in India at approximately 10-15 sites in phase II and 22-27 sites in phase III. “Gennova is using the DBT-ICMR clinical trial network sites for this study," it said.
mRNA vaccines belong to the category of nucleic acid vaccines, which use genetic material from disease-causing viruses or pathogens to trigger an immune response against it within the body.