NEW DELHI, June 20 (PTI): Pune-based Gennova Biopharmaceuticals Ltd on Tuesday said its mRNA COVID-19 booster vaccine against the Omicron variant, GEMCOVAC-OM, has received emergency use authorisation from the Drugs Controller General of India.
The company claimed that GEMCOVAC-OM is the first booster COVID-19 vaccine developed in India against the Omicron variant.
In a virtual press conference, Gennova Biopharmaceuticals Ltd CEO Dr Sanjay Singh said the booster vaccine demonstrated robust immune responses in about 3,000 subjects in the clinical trials conducted at 20 centres across 13 cities in India.
It was proven safe and well tolerated with no adverse events while the efficacy was also superior, he added.
The booster vaccine can be administered safely to individuals who have received two doses of either Covaxin or Covishield, the company said adding, it is stable at 2-8 °C.
It is an intradermal vaccine which is administered using a needle-free device called Tropis, developed by PharmaJet, USA.
On the significance of the vaccine, Singh said while the WHO has said the pandemic is over but COVID-19 is still not over and there is still a vulnerable population who may be affected by mini waves.
He further said the mRNA platform 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.
Singh, however, did not comment on the pricing of GEMCOVAC-OM saying it would be shared when it gets formally rolled out in two to three weeks.
On the company’s production capacity of the vaccine, he said Gennova would be ready to meet whatever demand that may come.
Also, the company is working on all possibilities of making it available through government, private and institutional channels.