By Shalini Bhardwaj
New Delhi [India], January 17 (ANI): The testing of Gennova Biopharmaceutical's mRNA vaccine for the Omicron variant of COVID-19 is subject to regulatory approvals, the company's official spokesperson informed on Monday.
The company spokesperson said, "Omicron specific variant of vaccine is under development and will be ready for human clinical trials, subject to regulatory approvals."
Meanwhile, the Pune-based Gennova Biopharmaceuticals has submitted phase 2 data of mRNA vaccine and has also completed the recruitment of phase 3 data.
It is the country's first messenger mRNA vaccine and is expected to launch in February.
Drugs Controller General of India's (DCGI) Subject Expert Committee (SEC) is expected to review the phase -1 data soon, said official sources.
"Gennova Biopharmaceuticals had filed its phase 2 data with Central Drugs Standard Control Organisation (CDSCO) on Friday," a company spokesperson told ANI.
The company has said clearly it is not seeking an emergency use authorisation (EUA) for the mRNA vaccine to be used a booster dose.
Earlier in the month of September 2021, Gennova issued a press statement and updated about the vaccines trials. The statement read: "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") back in August."
"Gennova had submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO), the Government of India's National Regulatory Authority (NRA).The Vaccine Subject Expert Committee (SEC) had reviewed the interim Phase I data, and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study," it had said.
The company also mentioned the number of trial sites and had 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."
mRNA vaccines belong to the category of nucleic acid vaccines which use genetic material from disease-causing virus or pathogen to trigger an immune response against it within the body. (ANI)