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

GEMCOVAC®-OM reinforces the importance of vaccination against the coronavirus
GEMCOVAC®-OM reinforces the importance of vaccination against the coronavirus

Pune-based Gennova Biopharmaceuticals Receives Approval for Omicron-Specific mRNA Booster Vaccine

Pune, India – Gennova Biopharmaceuticals Ltd, a leading biotechnology company in India, announced today that it has received Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI) for its mRNA-based COVID-19 booster vaccine named GEMCOVAC®-OM. This marks a significant milestone as it becomes the first booster vaccine in India specifically designed to combat the highly transmissible Omicron variant of the SARS-CoV-2 virus.

Revolutionizing Protection against the Omicron Variant

GEMCOVAC®-OM, developed through a partnership with the Department of Biotechnology, Government of India, has demonstrated robust immune responses in its phase 3 clinical trial conducted across 20 centers in 13 cities across India. The vaccine, administered intradermally using the needle-free device Tropis®, addresses the limitations of currently approved vaccines that were designed against the ancestral strain of the virus. By focusing on the Omicron variant, GEMCOVAC®-OM aims to reduce the probability of infection, hospitalization, and future waves of the pandemic.

Safe and Convenient Vaccination Option

Adults aged 18 years and older who have received two doses of either COVAXIN® or COVISHIELD™ can safely receive the GEMCOVAC®-OM booster vaccine. With its lyophilized (freeze-dried) formulation, the vaccine remains stable at 2-8 °C, ensuring convenient storage and transportation.

Dr. Sanjay Singh, CEO of Gennova Biopharmaceuticals Limited, highlighted the mRNA platform’s versatility in quickly developing vaccines for emerging variants. He emphasized that vaccines remain humanity’s best defense against deadly diseases, and Gennova is committed to meeting unmet medical needs and ensuring preparedness for future health emergencies.

A Step Forward in Global Vaccination Efforts

Mr. Samit Mehta, COO of Gennova Biopharmaceuticals Limited, expressed gratitude to the medical fraternity, government, and scientific community for their confidence in the mRNA technology and the development of the Omicron-specific vaccine. As accessibility challenges persist globally, GEMCOVAC®-OM, based on state-of-the-art mRNA technology, aims to provide a protective shield against COVID-19 in India and worldwide.

This approval of GEMCOVAC®-OM reinforces the importance of vaccination against the coronavirus

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