One of the second generation Covid-19 vaccine candidates –AKS-452 — developed by the US vaccine maker Akston BioSciences, has started its open label bridging study in India. The bridging study of the protein sub-unit vaccine will be conducted in 100 subjects in four sites in Maharashtra, including the Supe Heart and Diabetes Hospital and Research Centre at Nashik. Gujarat-based clinical research organisation, Veeda Clinical Research, is managing the India study. The open label bridging study will be followed with double-blind Phase-2/3 studies involving about 1500 healthy volunteers in India. 

AKS-45 has a shelf-stability of at least 6 months in a temperature of up 25 degree celsius and will even sustain potency in 37 degree celsius for one month, according to the company. The Drug Controller General of India had approved the open label study for the Akston Bio vaccine candidate based on the promising data submitted by the company from its Phase-2 trials in the Netherlands.