“We are excited about launching India’s first mRNA Covid-19 vaccine and talks are underway with the government on the rollout process. A short clinical trial will also be conducted with the Omicron variant-specific vaccine that has also been designed for use as a booster,” Samit Mehta, Chief Operating Officer (COO) of Gennova Biopharmaceuticals, told media persons at a virtual meeting on Wednesday.
On how soon the rollout is likely, Mehta said that talks were underway with the government on whether it would like to procure and deploy the vaccine or whether the firm can reach out to the private market. On pricing of the vaccine, Mehta said, “Compared to our peers, we will be competitive.”
Besides, a short clinical trial will be conducted with the Omicron-specific vaccine that has also been designed for use as a booster. The protocol for the same has been submitted to the regulator. Authorities at Gennova said that they were actively engaged in talks with at least 25-30 countries, which had evinced interest in the mRNA Covid-19 vaccine.
The vaccine, India’s first mRNA jab against Covid-19 that got Emergency Use Authorization (EUA), will be sold under the brand name GEMCOVAC-19. The vaccine will be available for adults above 18 years of age. It is a two-dose vaccine to be administered intramuscularly 28 days apart.
These vaccines are highly efficacious because of their inherent capacity of being translated into the protein structure inside the cell cytoplasm. Such vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. “This technology provides flexibility to quickly tweak the vaccine for any existing or emerging variants of the virus. This technology platform will empower India to be pandemic-ready,” Mehta said.
GEMCOVAC-19 has reached the primary endpoint of Phase-III clinical trial. The clinical data was evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic. Mehta, however said, that pregnant women were not part of the clinical trial. The COO said that paediatric trials were also being planned.
Gennova Biopharmaceuticals Limited, a subsidiary of Emcure Pharmaceuticals Limited, headquartered in Pune, aims to produce around 40-50 lakhs of doses per month. This capacity can be quickly doubled, officials said. Beyond India, Gennova aims at providing sustainable access of the vaccine to low-and middle-income countries around the world to blunt the spread of the pandemic. “Several countries in Latin America have evinced interest (in the vaccine),” Mehta said.
📣 Join our Telegram channel (The Indian Express) for the latest news and updates