PharmaJet partner, Gennova Biopharmaceuticals, filed 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.
The submission follows assessment of the primary endpoints of a Phase 2/3 study and corresponds with an increase in COVID-19 cases in India. It 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.
“The Tropis system is already commercially available in India, and we are well-prepared to rapidly support demand for the GEMCOVAC-OM Omicron booster,” Chris Cappello, president and CEO of closely-held PharmaJet, said in a statement. “We look forward to continuing our partnership with Gennova with additional novel vaccines.”
GEMCOVAC is a lyophilized vaccine and can be distributed through the existing refrigeration supply chain Pan-India and in low- and middle-income countries, without 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.
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.
