Clinical Trials Being Taken Up In India For Cholera Vaccines


Cholera is a bacterial infection that causes diarrhea, which kills the patients within hours, if left untreated. If patients are diagnosed in time, and treated with antibiotics and other measures at an early stage, they can recover and get back to their normal lives, but if not, they may have to lose their life! Cholera infects approximately 2.8 million people, causing 95,000 deaths every year! In 2018, there was a global demand for around 100 million doses of cholera vaccine, but the supply was only somewhere around 20 million; so you can imagine the sad face of the outbreak!

Today, the world relies only on two suppliers for cholera vaccines – one from South Korea, and the other from India; but, the global demand for cholera vaccines is higher than the supply. This is why large-scale clinical trials are being planned to be conducted, and a Swedish-designed cholera vaccine is to be commercialized to help fight persistent outbreaks of cholera in India and abroad.

The Hilleman-Bharat pact

It is the Hyderabad-based Bharat Biotech that signed a pact with the New Delhi-based Hilleman Laboratories to speed up the development and clinical trials. Also, the manufacture of the new oral cholera vaccine needs to be accelerated for the drug to be supplied to low and middle income countries. This collaboration of Bharat Biotech and Hilleman Laboratories has been mainly done to address the global shortage of cholera vaccines, in the midst of the persistence of outbreaks in several states across India and Africa.

What is the pact about?

Under the pact, Hilleman laboratories have licensed to Bharat Biotech the vaccine designed by scientists at the University of Gothenburg, Sweden. The vaccine’s safety and capacity to produce an immune response to cholera has already been established by Hilleman laboratories through limited Phase-1 and Phase-2 clinical trials in Bangladesh. Bharat Biotech, thus, has to conduct larger Phase-3 trials and scale up the vaccine production process for commercialization, while also seeking a pre-qualification certification from the World Health Organization, to enable it to supply the vaccine through global funding agencies. The entire process may take somewhere around three years, but the capacity to deliver 50 million doses every year will resolve the uncertainty over supply.

Cholera widespread in India

In India, the highest risk of cholera is in Bengal. In fact, Ancient Asiatic cholera strains have also thrived in the Ganges delta, making Bengal very unsurprisingly the most highly affected state. In fact, almost 50% of cholera cases seen in India every year have been in Bengal. Next in line come Karnataka, Gujarat, Maharashtra, Punjab, Odissa, and Assam. With a goal to produce an affordable vaccine that improves access to millions of cholera patients not only in India, but worldwide too, the vaccine that is being tested could be a key tool in the Narendra Modi government’s Swachh Bharat Abhiyaan campaign, which seeks to improve the levels of sanitation, and the access to clean drinking water.

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