Gennova Biopharmaceuticals has applied for an emergency use authorisation (EUA) from the Drug Controller General of India (DCGI) for its mRNA-based Omicron-specific Covid-19 booster vaccine.
The firm, which is a partner of PharmaJet, has submitted interim safety and immunogenicity endpoints data from the Phase II/III trial to the Indian regulator to secure the EUA.
The move follows a rise in the incidence of Covid-19 in India.
Pharmajet stated that Gennova’s booster is the first in India for treating the Omicron variant.
Dubbed GEMCOVAC-OM, the needle-free vaccine will be delivered intradermally with the PharmaJet Tropis Precision Delivery System (PDS).
The lyophilised vaccine remains stable at 2°C-8°C and can be distributed using the current refrigeration supply chain across India, along with other low and middle-income countries (LMICs).
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Unlike other approved mRNA vaccines, GEMCOVAC-OM need not be stored in ultra-low temperature environments.
The vaccine was evaluated for its safety and immunogenicity as a booster in subjects who received two doses of Covishield and Covaxin, the two major Covid-19 vaccines administered in the country.
Gennova Biopharmaceuticals CEO Sanjay Singh said: “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 lyophilised mRNA platform.”
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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