India’s Gennova Biopharmaceuticals Receives DCGI Approval for mRNA-Based Omicron-Specific Booster Vaccine

Pune, India: Gennova Biopharmaceuticals Ltd, a prominent company based in Pune, has announced that its mRNA-based COVID-19 booster vaccine, GEMCOVAC®-OM, specifically developed to combat the Omicron variant of SARS-CoV-2, has received Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI).

GEMCOVAC®-OM is the first booster vaccine developed in India to target the highly transmissible Omicron variant. In the phase 3 clinical trial conducted at 20 centers across 13 cities in India, GEMCOVAC®-OM demonstrated robust immune responses. Approximately 3,000 individuals participated in the Phase-II/III trials, with the vaccine proving to be safe and well-tolerated.

While the currently approved vaccines serve as precautionary or booster doses, they were designed to address the ancestral strain of SARS-CoV-2. Although they increase antibody titers, their efficacy in neutralizing the circulating Omicron variant is limited. Developing antibodies and memory immune responses specific to the Omicron variant is crucial in reducing the likelihood of infection, hospitalization, and future waves of the pandemic. GEMCOVAC®-OM is specifically designed to bridge this gap.

GEMCOVAC®-OM is a lyophilized (freeze-dried) vaccine that remains stable at temperatures of 2-8 °C. It is administered intradermally using a needle-free device called Tropis®, developed by PharmaJet, USA. This innovative approach eliminates the drawbacks associated with needle usage, such as needle phobia, sharps disposal, and needle-stick injuries.

Dr. Sanjay Singh, CEO of Gennova Biopharmaceuticals Limited, emphasized the company’s commitment to addressing health emergencies and the evolving nature of COVID-19. With the realization that the virus will persist and continue to mutate, the mRNA platform developed in collaboration with the Department of Biotechnology, Government of India, offers a rapid response for developing vaccines targeting future variants of concern. Vaccines remain the most effective defense against deadly diseases.

Mr. Samit Mehta, COO of Gennova Biopharmaceuticals Limited, expressed pride in developing India’s first Omicron-specific vaccine within a short timeframe. Understanding the accessibility challenges faced during the distribution of COVID-19 vaccines globally, Gennova is pleased to offer a vaccine based on state-of-the-art mRNA technology. The company extends its gratitude to stakeholders including the medical fraternity, government, and scientific community for their confidence in the mRNA technology and the Omicron-specific vaccine. The mRNA vaccine platform continues to serve as a protective shield for India and the world in the fight against Coronavirus.

The development and approval of GEMCOVAC®-OM mark a significant milestone in India’s battle against the Omicron variant. This achievement showcases the nation’s scientific capabilities and commitment to finding innovative solutions to public health challenges. With the introduction of GEMCOVAC®-OM, India takes a significant step forward in its vaccination efforts, further strengthening its defense against the evolving threat of the coronavirus.

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