Pune-based pharmaceutical manufacturer Gennova Biopharmaceuticals Ltd has almost completed the phase 3 trials of its Covid-19 messenger or mRNA vaccine even as the company has started developing an Omicron-specific vaccine using the same technology. Gennova has developed an mRNA vaccine for the Omicron variant, which will be tested for safety and efficacy for use in humans, a Times of India report said.
Messenger RNA or mRNA technology involves the injection of a small part of the virus’s genetic code (RNA) to stimulate the recipient’s immune response. It contains instructions for human cells to make proteins that mimic part of the novel coronavirus, spurring the immune system into action. No actual virus is contained in the vaccines.
The mRNA vaccines were recommended by expert Dr Gagandeep Kang as the best for booster doses. In collaboration with HDT Biotech Corporation, USA, Gennova has developed an mRNA vaccine candidate (HGCO19), with demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models, a senior government official had told News18.
Gennova is close to completing phase 3 trials of its Delta variant-based two-dose mRNA after having submitted the phase 2 trial data of over 3000 subjects, the Times of India report said. India’s drug regulator is expected to review the data this week and take a decision regarding approval, the report added.
“The drug regulator will study and take a decision on whether an approval can be given,” Dr NK Arora, chairman of India’s technical advisory group on Covid vaccination reportedly said.
The development of an mRNA vaccine is a significant achievement for the country, Dr VK Paul, Covid-19 task force chief was quoted by Times of India as saying. Paul said that the thermos-stable vaccine, using the existing cold-chain infrastructure, and the platform could be useful beyond Covid too.
Internationally, Pfizer CEO Albert Bourla told CNBC that a vaccine that targets the omicron variant of Covid will be ready in March, and the company’s already begun manufacturing the doses. Experts however say that it could be “too late” due to the variant’s highly transmissible nature.