A startup incubated in the Indian Institute of Science (IISc), Bengaluru, is developing a Covid-19 vaccine that can be stored at 37 degrees Celsius, a development that could be a game-changer for India which lacks sufficient cold chain facilities.
“All (Covid) vaccine candidates in clinical trials currently require refrigerated temperatures of at least four degrees. Ours would not, in principle,” biophysicist Raghavan Varadarajan, who heads the startup Mynvax, told DH.
“For Covid-19, no one has shown equivalent data of the temperature. We have exposed it to much higher temperatures than 37 degrees for shorter periods of time, and it was okay.”
The heat-tolerant vaccine can also withstand heat of 70C for about 16 hours. In comparison, the front runner, AstraZeneca-Oxford’s Covishield vaccine, manufactured by Pune’s Serum Institute, will have to be refrigerated at 2-8 degrees.
To put things in perspective, Karnataka has 2,900 cold chain points. As many as 10.52 lakh children up to the age of 16 are vaccinated under routine immunisation programmes every year apart from pregnant women.
But with the Covid-19 vaccine, the state needs cold chain points that can cater to its entire estimated population of 7.07 crore.
Varadarajan’s team has carried out extensive animal testing in mice and guinea pigs with promising results. Currently, challenge studies in hamsters are in progress, with the animal trials expected to be completed by December. The final formulation will then be advanced to process development, animal safety and toxicity studies and, subsequently, clinical trials.
Mynvax, co-founded by Varadarajan, recently received some funding from the IISc but the bulk of the Covid-19 vaccine work done so far has been carried out with the startup’s own funds, Varadarajan told DH.
The molecular biophysics professor said Rs 15 crore is required for the vaccine to be administered in human clinical trials. If everything goes well, the vaccine can be licensed by mid-2022, Varadarajan said.
“Once we are able to secure sufficient funding, we will advance it into clinical testing. Right now, we have not yet received the funding to take it forward,” he said, adding that the immunogenicity studies to see what kind of antibodies are made had been completed.