Omicron-specific mRNA Booster From Gennova Gets DCGI Approval
Pune-based Gennova Biopharmaceuticals mRNA booster for Covid 19 has received the nod from the office of the Drugs Controller General of India (DCGI). The booster vaccine, Gemcovac-OM works against the Omicron variant of SARS-CoV-2 and has received emergency use authorization (EUA) from the regulatory authority.
Gemcovac is the first booster COVID-19 vaccine developed in India against the highly transmissible Omicron variant. The booster vaccine has demonstrated robust immune responses in the phase 3 clinical trial conducted at 20 centres across 13 cities in India In Phase II/ III trials, approximately 3000 individuals received Gemcovac 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 neutralize 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 hospitalization and prevent future waves of the pandemic. Gemcovac is a lyophilized (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, of 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 realization 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.”
