The indigenous heat-stable vaccine, once cleared for use, will best suit India’s weather and could potentially revolutionise vaccine delivery in the fight against Covid-19.
Currently, all the three Covid-19 vaccines available in the country — Covishield, Covaxin and Russia’s Sputnik V — need to be stored at 2-8 degree Celsius. IISc’s vaccine molecule is, however, thermostable and can be stored at room temperature. The “warm vaccine” is important in the Indian context because it would not require massive cold chain infrastructure and transportation to deliver to remote towns and villages.
Its initial findings were published in the American Society for Biochemistry and Molecular Biology’s weekly peer-reviewed scientific journal, Journal of Biological Chemistry (JBC).
“We now have better vaccine formulations, relative to those we described in our JBC publication last year, that elicit antibodies which are able to neutralise some of the mutant viruses of concern and continue to be thermotolerant,” says Raghavan Varadarajan, professor at the Molecular Biophysics Unit of IISc, who co-founded biotech startup Mynvax along with scientist Gautham Nadig. “We now need to move forward urgently into clinical development.”
The animal data compares favourably with equivalent data from approved Covid-19 vaccines, according to Varadarajan.
“Neutralising antibody titers (which are thought to correlate immunity with infection) that we obtained from administering our current vaccine to mice are considerably higher than in convalescent sera present in humans who have recovered from Covid-19,” he says.
Convalescent serum refers to blood serum obtained from a person who has recovered from the infection, and which contains antibodies against the virus.
“In previous studies, it was seen that titers of neutralising antibodies found in animal trials of Covid-19 vaccine formulations are similar to those in humans that receive a similar formulation and likely to be correlated with the efficacy of the vaccine,” he added.
The team has yet to conduct process development as well as safety and toxicity study, which are required before progressing to clinical trials.
Funding has been a bottleneck.
Both the process development – which has to be done outside the institute either by a clinical research organisation or a manufacturer – and the safety and toxicity study require significant sums for the ambitious project to succeed.
Mynvax has been in talks with a couple of manufacturers and has also approached both the government and private institutions to raise capital. However, it has not materialised so far.
“We weren’t able to proceed to clinical development due to lack of funds,” Varadarajan says.
Manufacturers, at least in the past, were perhaps apprehensive about signing up because Covid-19 cases had declined drastically, and it was not clear whether the country needed another vaccine. “But now, with the devastating second wave, perhaps this will change,” he says.