GEMCOVAC-OM is a lyophilised (freeze-dried) vaccine, stable at 2- 8 °C
Pune-based Gennova Biopharmaceuticals announced that its mRNA COVID-19 booster vaccine – GEMCOVAC-OM – against the Omicron variant of SARS-CoV-2 received Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI).
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 phase 3 clinical trials conducted at 20 centres across 13 cities in India in Phase II/ III trials, approximately 3000 individuals received GEMCOVAC-OM and the vaccine was safe and well tolerated.
The currently approved vaccines used as precautionary/ booster doses are designed against the ancestral strain of SARS-CoV-2. Although these will increase the antibody titers, their ability to neutralise the circulating Omicron variant of SARS-CoV-2 is limited. Developing antibodies and memory immune responses specific to the Omicron variant would reduce the probability of infection and hospitalisation and prevent future waves of the pandemic. The Made-in-India GEMCOVAC-OM specifically addresses this gap.
GEMCOVAC-OM is a lyophilised (freeze-dried) vaccine, stable at 2- 8 °C. It is delivered intradermally using a device called Tropis, developed by PharmaJet, USA. This is a needle-free device that obviates the disadvantages of using a needle, such as a needle phobia, sharps disposal, and needle-stick injuries, to name a few.
Dr Sanjay Singh, CEO, Gennova Biopharmaceuticals, said, “The Gennova team, as a 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, which 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, if any. Vaccines have remained the best shield for mankind against deadly diseases.”
Samit Mehta, COO, Gennova Biopharmaceuticals, 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 state-of-the-art technology, the mRNA. We are thankful to our stakeholders – medical fraternity, government, the scientific community – for espousing confidence in our effort 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.”
