- Interim report of the safety and immunogenicity endpoints from the Phase II/III study has been submitted to the Drug Controller General of India (DCGI) for Emergency Use Authorization.
- Vaccine is delivered intradermally with the PharmaJet Tropis® Needle-free Precision Delivery System™.
- Unlike other approved mRNA vaccines requiring ultra-low temperature storage, this vaccine uses the existing refrigeration supply chain.
GOLDEN, Colo. — April 3, 2023 – Following assessment of the primary endpoints of the Phase II/III study, PharmaJet partner Gennova Biopharmaceuticals Limited 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 India1 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 countries (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 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 Delivery 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.”
Refer to Instructions for Use to ensure safe injections and to review risks.
1 Ministry of Health and Welfare – Government of India, https://www.mohfw.gov.in/
The PharmaJet vision is to enable greater access to life-saving vaccines and pharmaceuticals globally. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Precision Delivery Systems™ provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. They are both commercially available for global immunization programs. For more information visit https://pharmajet.com. Follow us on LinkedIn.
Gennova Biopharmaceuticals Ltd., headquartered in Pune, India, is a biotechnology company dedicated to the research, development, production, and commercialization of biotherapeutics and vaccines to address life-threatening diseases across various indications. To find out more, visit https://gennova.bio