" class="no-js "lang="en-US"> Gennova Seeks Authorization in India for Omicron Booster
Friday, June 09, 2023

Gennova Biopharmaceuticals seeks Emergency Use Authorization in India for the First Needle-free mRNA Vaccine Omicron Booster

Following assessment of the primary endpoints of the Phase II/III study, PharmaJet partner Gennova Biopharmaceuticals has submitted data for its mRNA-based Omicron specific Covid-19 booster shot for Emergency Use Authorization (EUA) to the office of the Drug Controller General of India (DCGI). The submission corresponds with an increase in COVID-19 cases in India and is the first booster in India targeted specifically for the Omicron variant.

The vaccine, GEMCOVAC-OM, will be delivered exclusively with the PharmaJet Tropis Precision Delivery System (PDS). GEMCOVAC-OM is a lyophilized vaccine, stable at 2-8 °C, which means it can be distributed through the existing refrigeration supply chain Pan-India and in low- and middle-income coun- tries (LMICs). Unlike other approved mRNA vaccines, it does not require ultra-low temperature storage conditions. GEMCOVAC-OM was assessed for its safety and immunogenicity when 2 Doc. #60-10663-005D administered as a booster in participants who have received two doses of COVISHIELD and COVAXIN, the two main COVID-19 vaccines used in India. The vaccine is delivered needle-free, intradermally with the PharmaJet Tropis Precision Deliv- ery System which has been shown to reliably enhance nucleic acid vaccine immune response.

“We are seeing encouraging results with precise intradermal delivery of our vaccine using the PharmaJet Tropis needle-free solution. After launching this Omicron booster, we are eager to grow the partnership with PharmaJet to leverage all the benefits of needle-free delivery and our lyophilized mRNA platform,” said Sanjay Singh, CEO of Gennova Biopharmaceuticals. “Our partnership with Gennova Pharma and their Omicron booster clinical program confirms the value of choosing our widely validated and rapidly scalable Precision Delivery Systems to improve the effectiveness of DNA and mRNA vaccines,” said Chris Cappello, President and CEO, PharmaJet. “The Tropis System is already commercially available in India, and we are well-prepared to rapidly support demand for the GEMCOVAC-OM Omicron booster. We look forward to continuing our partnership with Gennova with additional novel vaccines.”

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