Government struggles to find pharma partners for salmonella vaccine

The Union health ministry is confronting challenges in finding pharmaceutical partners for the research, development, manufacturing, and commercialisation of a salmonella vaccine, used against typhoid and gastroenteritis. 

The Indian Council of Medical Research (ICMR), through the Ministry of Health and Family Welfare, has reopened its call for expressions of interest twice in the last three months, as no proposals were received from pharmaceutical companies.

The ICMR, India’s biomedical research body, is looking to develop a broad-spectrum vaccine against Salmonella Typhi, Salmonella Paratyphi, and Salmonella Typhimurium. Salmonella is a type of bacteria that can cause infections in humans and animals.

These infections often lead to illnesses like typhoid fever, paratyphoid fever, and gastroenteritis. The bacteria are typically transmitted through contaminated food or water and can cause symptoms such as diarrhea, fever, abdominal cramps, and vomiting. There are several different strains of Salmonella, with Salmonella Typhi, Salmonella Paratyphi, and Salmonella Typhimurium being some of the most common ones that affect humans.

ICMR-National Institute of Cholera and Enteric Diseases (ICMR-NICED), a constituent institute of ICMR, has developed a novel vaccine candidate against these diseases drawing from a new technology that they have called “Technology.”

“Due to the inadequate number of responses received during the previous call for Expressions of Interest (dated 01.03.2024 with a closing date of 31.03.2024), the competent authority has decided to reopen the call for joint collaboration in R&D, manufacturing, and commercialisation of a broad specificity Salmonella vaccine against typhoid, paratyphoid fever, and Salmonella Typhimurium gastroenteritis. Interested vaccine manufacturers, pharmaceutical companies, and R&D institutions are encouraged to submit their interest,” said a senior scientist at ICMR, adding that the closing date of submission now is July 12, 2024.

In the joint collaboration, ICMR will partner with eligible manufacturers to validate this technology and together they will develop and commercialise a broad-spectrum vaccine that is regulated, marketed in two scheduled phases. ICMR looks forward to providing the technology and technical support to the selected company after signing a non-disclosure agreement for the Phase I, in which the company will independently validate the vaccine and share generated data with the ICMR.

In the subsequent Phase II, both parties will synergise their resources for the advancement of the vaccine, ultimately aiming for regulatory approval and commercial production. The selected partner is expected to provide necessary infrastructure, material, manpower for product validation, and take responsibility for obtaining regulatory approvals required for commercialisation.

The intent of this partnership is not only the fruitful production and marketing of the Salmonella vaccine, but also crucially to address the pressing public health issues arising from typhoid and gastroenteritis, the government said. “ICMR’s initiative represents an opportunity for eligible manufacturing companies to collaborate on a great project,” said the scientist.

Hyderabad based companies Bharat Biotech and Biological E currently manufacture some salmonella vaccines in the country.

Research suggests that the incidence of typhoid fever in India is around 360 cases per 100,000 person-years, translating to an estimated 4.5 million cases annually. However, there is no specific figure of the burden of salmonella caused gastroenteritis, a recent study from the Centres for Disease Control and Prevention (CDC) highlighted the rising concern of multidrug-resistant Salmonella strains in India.