PharmaJet, in collaboration with Gennova Biopharmaceuticals Limited, has submitted data for their mRNA-based Omicron specific Covid-19 booster shot to the office of the Drug Controller General of India (DCGI) for Emergency Use Authorization (EUA).
In light of the recent surge in COVID-19 cases in India, GEMCOVAC-OM, the first booster targeted specifically for the Omicron variant, will be delivered exclusively with the PharmaJet Tropis Precision Delivery System (PDS). This is a crucial step towards providing a much-needed solution to combating the virus.
GEMCOVAC-OM, a lyophilized vaccine which is stable at 2-8 °C, is a boon for India and other low- and middle-income countries (LMICs), as it can be easily distributed through the existing refrigeration supply chain. Unlike other approved mRNA vaccines, it does not require ultra-low temperature storage conditions.
What makes it even more special is the fact that it was assessed for safety and immunogenicity when administered as a booster to those who had already received two doses of COVISHIELD and COVAXIN, the two main COVID-19 vaccines used in India. GEMCOVAC-OM is truly a revolutionary vaccine for our time.
Gennova Biopharmaceuticals is thrilled to be leveraging the PharmaJet Tropis Precision Delivery System to deliver its revolutionary nucleic acid vaccine with needle-free, intradermal administration.
The PharmaJet Tropis needle-free solution has been clinically demonstrated to significantly enhance the immune response of the vaccine, and the Gennova team is thrilled to be boosting this partnership in order to leverage all the benefits of their lyophilized mRNA platform.
Sanjay Singh, CEO of Gennova Biopharmaceuticals, commented, “We are seeing very encouraging results with precise intradermal delivery of our vaccine, and we are eager to keep pushing forward in this exciting new area.”
PharmaJet is delighted to be partnering with Gennova Pharma and their Omicron booster clinical program, which uses the highly validated and scalable Precision Delivery Systems to boost the efficacy of DNA and mRNA vaccines.
The Tropis System is already commercially available in India, and PharmaJet is ready to support the demand for GEMCOVAC-OM Omicron booster. With this collaboration, PharmaJet looks forward to creating even more novel vaccines with Gennova in the future.
PharmaJet is revolutionizing the way vaccines and pharmaceuticals are delivered, with the aim of enhancing global access to life-saving treatments. Our Precision Delivery Systems™ have been granted U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification, meaning they are safe, fast, and easy-to-use.
The Stratis® System offers intramuscular and subcutaneous delivery, while our Tropis® System has CE Mark and WHO PQS certification for intradermal injections. With these systems, we are helping our partners achieve their research and commercialization goals, while making a real difference in public health.
Gennova Biopharmaceuticals Ltd. is a pioneering biotechnology company headquartered in Pune, India, working to make a difference in the world of life-threatening diseases. With a commitment to research, development, production and commercialization of biotherapeutics and vaccines, Gennova is at the forefront of the battle to beat these medical conditions.