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Notably, GEMCOVAC-19 has reached the primary end point of the Phase-III clinical trial. The clinical data was evaluated by the Central Drugs Standard Control Organisation (CDSCO). (Representational)Talks are underway with the Centre on rolling out India’s first mRNA Covid-19 vaccine, said Samit Mehta, the chief operating officer (COO) of Gennova Biopharmaceuticals, during a virtual interaction with media persons Wednesday. He added that a short clinical trial will be conducted with the Omicron variant-specific vaccine that has also been designed for use as a booster.
Asked when the roll out is likely to happen, Mehta said they were discussing with the government if the latter 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.”
The first mRNA vaccine against Covid-19 to receive Emergency Use Authorization (EUA) in India, it will be sold under the brand name GEMCOVAC-19, company officials said.
“The vaccine will be available for adults above 18 years of age. It is a two-dose vaccine to be administered intramuscularly at 28 days apart… mRNA 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 and this technology platform will empower India to be pandemic ready,” Mehta said.
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Notably, GEMCOVAC-19 has reached the primary end point of the 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 said. He, however, added that pregnant women were not part of the clinical trial. The COO said that paediatric trials were also being planned.
Gennova Biopharmaceuticals Ltd, a subsidiary of Emcure Pharmaceuticals Ltd, headquartered in Pune aims to produce around 40-50 lakh doses per month.
Gennova officials also said they were in talks with at least 25-30 countries that had evinced interest in the company’s mRNA Covid-19 vaccine.
“Several countries in Latin America have evinced interest,” Mehta said.
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