India’s first home-grown mRNA COVID-19 vaccine, developed at Pune’s Gennova Biopharmaceuticals, is set to be a gamechanger as it can be stored at temperatures between 2 and 8 degree celsius, says Dr N K Arora, who heads the COVID-19 working group of the National Technical Advisory Group of Immunisation (NTAGI).
“The Phase III trial has been completed with the necessary follow-up and the interim data has been presented to the Central Drugs Standard Control Organisation,” Dr Arora told The Indian Express.
“I have yet to see the complete data. However this is cutting edge technology that will ensure availability of the product in remote areas. So this vaccine is a game-changer and brings about equity. Unlike in the West, where the vaccine has to be stored at sub-zero temperatures, our mRNA vaccine can be stored between 2 and 8 degree celsius,” he added. Which means that the vaccine, GEMCOVAC 19, can now be stored at the temperature of a standard medical refrigerator. Asked about the availability of the new vaccine, Dr Arora said, “Soon.” Dr Sanjay Singh, CEO of Gennova Biopharmaceuticals, could not be reached for comment.
Several lakhs of doses have been produced at the Gennova Biopharmaceuticals and authorities are a hopeful lot. The main aim was to innovate and ensure the mRNA vaccine could be made affordable and deployable. Scientists, biotechnologists, pharmacists and production personnel at the firm worked for over one-and-a-half years to come out with the Indian version of mRNA COVID-19 vaccine.
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Since there was a need to make the vaccine shots thermo-stable, hundreds of experiments were performed to distinguish between lab experiments and clinical trials before arriving at the right formulation and right condition. The Phase 1 and 2 trial data across 480 participants was submitted earlier. The interim data from Phase 3 trials across 4,000 participants has now been presented to the CDSCO.
Would the recent US FDA study about the rare incidence but increased risk of myocarditis or pericarditis after mRNA vaccination be a matter of concern? Prof Govindrajan Padmanabhan, former director of the Indian Institute of Science, Bengaluru and Chancellor of Central University of Tamil Nadu, said as of now there was no broad-based evidence that mRNA vaccine could lead to cardiac issues.
On booster doses, the expert said the precaution shot need not necessarily be the same vaccine. A mix and match strategy can be used and a Covishield vaccine can be followed by an mRNA vaccine, Prof Padmanabhan said. The Drug Controller and General of India (DCGI) authorities were unavailable for comment.