New oral cholera vaccine brings hope for global public health

By Larissa Warneck-Sivestrin

- Last updated on GMT

© Getty Images
© Getty Images
An international collaboration led by Hilleman Laboratories has confirmed the launch of a new oral cholera vaccine called HILLCHOL, hoping to address significant global shortages.

WHO key cholera facts 

  • Cholera is an acute diarrhoeal disease that can kill within hours if left untreated.
  • Cholera is a disease of poverty affecting people with inadequate access to safe water and basic sanitation.
  • Conflict, unplanned urbanization and climate change all increase the risk of cholera.
  • Researchers have estimated that each year there are 1.3 to 4.0 million cases of cholera, and 21 000 to 143 000 deaths worldwide due to cholera (1)​.
  • Most of those infected have no or mild symptoms and can be successfully treated with oral rehydration solution.
  • Severe cases need rapid treatment with intravenous fluids and antibiotics.
  • Provision of safe water and basic sanitation, and hygiene practices is critical to prevent and control the transmission of cholera and other waterborne diseases.
  • Oral cholera vaccines should be used in conjunction with improvements in water and sanitation to control cholera outbreaks and for prevention in areas known to be high risk for cholera.
  • A global strategy on cholera control, Ending cholera: a global roadmap to 2030​, with a target to reduce cholera deaths by 90% was launched in 2017.

Singapore-based Hilleman Laboratories – a joint venture of MSD, USA and the Wellcome Trust, UK – and its partner Bharat Biotech, an Indian biotechnology company, have brought a new oral cholera vaccine to market.

Cholera is an acute diarrhoeal infection that results from the ingestion of the bacterium Vibrio cholerae​. If left untreated, the infection can cause death within hours. Cholera outbreaks occur in low- and middle-income countries where there is inadequate access to clean water, food, and sanitation.

According to the World Health Organization (WHO), each year, there are up to four million cases of cholera and 21.000 to 143.000 deaths worldwide. In 2017, a global strategy for cholera control was launched with the aim of reducing cholera deaths by 90% by 2030.

While oral cholera vaccines already exist, only one manufacturer is currently supplying them, resulting in an annual shortage of approximately 40 million doses. To counteract this global shortage, Bharat Biotech has built large-scale manufacturing facilities in the Indian cities of Hyderabad and Bhubaneswar. Here, the company can produce up to 200 million doses of HILLCHOL.

The other cholera vaccines on the market contain more than one bacterial strain, while HILLCHOL is based on a single, genetically engineered inactivated strain that can prevent infection against two of the main cholera serotypes, Ogawa and Inaba. This single-strain approach is believed to significantly reduce production costs and allow greater access to cholera vaccines as the frequency of outbreaks increases.

“From day one our mission has been to develop affordable vaccines and biologics against infectious diseases for countries with the most severe unmet medical needs,” said Raman Rao, CEO of Hilleman Laboratories, in a public announcement.

“This new vaccine delivers on that pledge and provides an innovative template for the internationalization of future vaccine and biologics development from Singapore, that can positively impact global health.”

HILLCHOL’s story began in Sweden at Gotovax AB, a spin-off of the University of Gothenburg, where the inactivated cholera strain was developed. Hilleman Laboratories then supported next-stage development solutions, tested affordable manufacturing applications, and conducted Phase II clinical studies. Then, Bharat Biotech stepped in to conduct Phase III trials and brought the vaccine to market. The company now wants to receive pre-qualification for the HILLCHOL licensure from the WHO to distribute the vaccine globally.

“Vaccines provide the best intervention to prevent, limit, and control cholera outbreaks,” said Krishna Ella, executive chairman of Bharat Biotech.

“HILLCHOL is an excellent success story of partnership leading to public health solutions.”

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