Hilleman and Bharat Biotech launch oral cholera vaccine in India

Hilleman Laboratories announced its partner Bharat Biotech has launched its Hillchol oral cholera vaccine, which makes use of a single, genetically engineered inactivated Hikojima bacteria strain.

Bharat Biotech received approval for licensure in India where Hillchol vaccines are currently manufactured in Hyderabad. The company intends to pursue prequalification for licensure from the World Health Organization (WHO) for global distribution.

The announcement follows the completion of the Hillchol vaccine’s successful Phase III clinical trial. Hilleman developed the vaccine through Phase II before transferring it to Bharat Biotech.

N Erlyani Abd Hamid, assistant director of business strategy and programme management at Hilleman Laboratories, told BioProcess Insider “Bharat Biotech has advised that its large-scale manufacturing facilities in Hyderabad and Bhubaneswar [India] have the capacity to produce approximately 200 million doses of Hillchol [vaccine] to help mitigate the current global shortage of cholera vaccines.” She said such a process can pave the way for the vaccine to be available in countries eligible for support by Gavi, the Vaccine Alliance.

Cholera is a deadly bacterial disease that causes diarrhea and severe dehydration in those affected.

Hilleman was founded in Singapore in 2009 as a joint venture between the large pharmaceutical company Merck Sharp & Dohme LLC (MSD, known as Merck & Co. In North America) and Wellcome Trust, which is a charitable foundation in the UK. It was established as a hub to accelerate end-to-end research and vaccine development for distribution in LMICs.

Raman Rao, CEO of Hilleman Laboratories said during the product launch, "Our mission has been to develop affordable vaccines and biologics against infectious diseases for countries with the most severe unmet medical needs. 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.” He credited the successful Hillchol vaccine launch to the collaborative efforts of Hilleman Laboratories, Bharat Biotech, the University of Gothenburg, and Gotovax AB.

The University of Gothenburg and spin-off biopharmaceutical company Gotovax AB developed the Hikojima strain for the Hillchol vaccine. Hilleman then led the next stages of development and manufacturing before conducting Phase II clinical studies.

A 2020 study conducted by researchers from Wellcome Trust and the University of Gothenburg highlighted the Hillchol vaccine, comparing it with oral vaccines already available for cholera. The paper stated that while the three existing vaccines are effective, their multiple-strain composition and two-method inactivation made them more complex and expensive to produce.

Hamid said that although the production and usage of oral cholera vaccines have increased significantly over the past decade, rising from about four million doses globally in 2012 to 35 million in 2022, “a gap is emerging between maximum production capacity and the projected public health needs for preventative vaccination campaigns.” By 2028, an estimated 65 million doses will be needed with only 25 million or so available.

“We believe Hillchol [vaccines] can play a critical role in meeting a significant portion of this demand.”