Gennova Biopharmaceuticals Ltd - File Photo
MUMBAI, 20 JUNE, 2023 (HPN): Gennova Biopharmaceuticals Ltd launched mRNA Covid-19 booster vaccine, 'Gemcovac Om', has received emergency use authorisation from the office of the Drugs Controller General of India for the Omicron variant. The vaccine is the first booster Covid-19 vaccine developed in India against the highly transmissible Omicron variant and has demonstrated robust immune responses in phase 3 clinical trials. It is stable at two to eight degrees Centigrade and has been developed using Gennova's indigenous platform technology, supported under 'Mission Covid Suraksha'.
Gennova Biopharmaceuticals Ltd, a Pune-based company, has announced that its mRNA Covid-19 booster vaccine, ‘Gemcovac Om’, against the Omicron variant of Covid, has received emergency use authorisation (EUA) from the office of the Drugs Controller General of India (DCGI). While the department of Biotechnology (DBT) on Tuesday announced that the Omicron-specific, mRNA-based, booster vaccine developed by Biotechnology Industry Research Assistance Council (BIRAC) using Gennova’s indigenous platform technology and supported under ‘Mission Covid Suraksha’, has got the nod from the office of the Drugs Controller General of India (DCGI) for EUA.
Gennova Biopharmaceuticals Ltd, a Pune-based company, has announced that its mRNA Covid-19 booster vaccine, ‘Gemcovac Om’, against the Omicron variant of Covid, has received emergency use authorisation
The press release stated, “DBT has facilitated establishing Gennova’s mRNA-based, next-generation vaccine manufacturing for developing the platform technology from proof of concept till phase 1 clinical trial of the prototype mRNA-based vaccine developed against the Wuhan strain. The project was further supported under ‘Mission Covid Suraksha’. The Indian ‘Covid-19 Vaccine Development Mission’ by DBT’s dedicated mission implementation unit at BIRAC, for further clinical development and scale-up of the prototype vaccine, which received EUA on June 29, 2022.”
The platform technology was used to develop an Omicron-specific booster vaccine for Covid-19. ‘Gemcovac Om’ is the first booster Covid-19 vaccine developed in India against the highly transmissible Omicron variant. ‘Gemcovac Om’ has demonstrated robust immune responses in the phase 3 clinical trials conducted at 20 centres across 13 cities in India. In the phase 2/3 trials, approximately 3,000 individuals received ‘Gemcovac Om’ and the vaccine was safe and well tolerated.
The currently approved vaccines used as precautionary or booster doses are designed against the ancestral strain of SARS-CoV-2. Developing antibodies and memory immune responses specific to the Omicron variant will reduce the probability of infection and hospitalisation, and prevent future waves of the pandemic. The made-in-India ‘Gemcovac Om’ specifically addresses this gap. The vaccine is a lyophilised (freeze dried) vaccine, stable at two to eight degrees Centigrade, according to a Gennova statement.
Dr Sanjay Singh, chief executive officer (CEO), Gennova Biopharmaceuticals Ltd, said, “The Gennova team, as part of the global scientific community’s endeavour to meet unmet medical needs, is geared for dealing with health emergencies. There is a realisation that Covid-19 will remain and keep mutating and therefore, we need to be prepared with vaccines to deal with emerging variants. The mRNA platform, that was developed in association with the department of Biotechnology, Government of India, provides an opportunity for a quick turnaround for vaccine development for any variants of concern in future. Vaccines have remained the best shield for mankind against deadly diseases”.
Samit Mehta, chief operating officer (COO), Gennova Biopharmaceuticals Ltd, said, “Gennova has successfully developed India’s first Omicron-variant vaccine within a few months. Being aware of the accessibility challenges the world witnessed for the Covid-19 vaccines, we are happy that we are providing a vaccine based on a state-of-the-art technology, the mRNA. We are thankful to our stakeholders – medical fraternity, government, scientific community - for espousing confidence in our efforts towards the mRNA technology and now, the Omicron-specific vaccine. The mRNA vaccine platform continues to remain a protective shield for India and the world against coronavirus”.
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