Pune's Gennova Biopharmaceuticals is developing an Omicron-specific COVID-19 vaccine, a company spokesperson said on Monday. The pharmaceutical manufacturer has already filed its phase 2 data with Central Drugs Standard Control Organisation (CDSCO) on Friday, the spokesperson added.
"Gennova Biopharmaceuticals had filed its phase 2 data with Central Drugs Standard Control Organisation (CDSCO) on Friday. The Omicron specific variant of vaccine is under development & will be ready for human clinical trials, subject to regulatory approvals," news agency ANI quoted the spokesperson of Gennova Biopharmaceuticals as saying.
According to reports, the mRNA vaccine developed by Gennova Biopharmaceuticals for the Omicron variant will soon be tested on humans for determining its efficacy and immunogenicity. This vaccine could be ready in a month or two, a person with direct knowledge of the matter told international news agency Reuters.
Earlier in the month of September 2021, Gennova issued a press statement and updated about the vaccines trials. "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 said.
The company also mentioned the number of trials sites. "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.
