Bio Farma's Bio-TCV typhoid conjugate vaccine licensed in Indonesia following marketing approval

International Vaccine InstituteNov 9 2023

The International Vaccine Institute (IVI), an international organization with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health, and Bio Farma, a biotechnology company based in West Java, Indonesia, announced today that Bio Farma's Bio-TCV^® typhoid conjugate vaccine (TCV) was licensed in Indonesia following marketing approval from Badan Pengawas Obat dan Makanan (BPOM), the national regulatory authority.

Bio-TCV^® is a Vi polysaccharide vaccine conjugated to the diphtheria toxoid carrier protein (Vi-DT), initially developed at IVI and transferred to Bio Farma in 2014. From the outset, the scope of the joint vaccine development program included preclinical development and Phase I-III clinical trials followed by technical support through local licensure and submission for prequalification (PQ) from the World Health Organization (WHO), a designation that enables agencies such as Gavi, the Vaccine Alliance to purchase the vaccine for global public health use. This decade-long partnership in pursuit of another safe, effective, and affordable TCV has been in part funded by a grant from the Bill & Melinda Gates Foundation.

We join Bio Farma in celebrating today's exciting news of Bio-TCV®'s local licensure, a milestone after nearly a decade of collaboration. We're grateful to the Bill & Melinda Gates Foundation for funding support of this vaccine development program, and to the project sites across Indonesia for their partnership. With emerging evidence that climate change and the increasing rise of antimicrobial resistance are impacting the prevalence and severity of typhoid fever, prevention of disease through vaccination is a key measure for typhoid control. We look ahead now to Bio-TCV®'s WHO PQ and introduction to the global health market."

Dr. Sushant Sahastrabuddhe, Acting Deputy Director General, Clinical, Assessment, Regulatory, Evaluation at IVI

Shadiq Akasya, President Director of Bio Farma, said: "Through good collaboration with IVI, Bio Farma has been able to successfully develop typhoid conjugate vaccine (Bio-TCV). Licensure of our typhoid conjugate vaccine (Bio-TCV) from our National Agency for Drug and Food Control (BPOM) has added yet another product to our product portfolio. Bio-TCV will undoubtedly be an important tool in the prevention of typhoid infection affording protection against this disease as early as 9 months of age. The successful development of Bio-TCV is testament to Bio Farma's commitment to global health; combating infectious diseases through the provision of safe and efficacious vaccines that comply with international standards of quality."

Dr. Duncan Steele, Deputy Director and Strategic Lead of Enteric Vaccines at the Bill & Melinda Gates Foundation, said: "We celebrate the licensure of Bio-TCV in Indonesia, another milestone for PT Bio Farma in their licensed vaccines and another great example of partnerships making the difference to advance vaccines for public health use. IVI's leadership in developing and transferring the technology to Bio Farma is a credit to both organizations."

IVI and Bio Farma confirmed the safety and immunogenicity of a single dose of Vi-DT and its non-inferiority to a control WHO-prequalified TCV in a Phase III clinical trial across three provincial capital cities in Indonesia. With the results of this study, BPOM approved the vaccine for national use in individuals ages 9 months to 45 years. Bio Farma will submit the dossier for WHO PQ, which, if achieved, will add an affordable TCV to the global public market that will be made available to low-income countries through Gavi, the Vaccine Alliance.

Typhoid fever is a potentially life-threatening febrile illness caused by Salmonella typhi that particularly affects children and young adults. According to the WHO, there are an estimated 11 to 20 million typhoid cases every year, largely in low- and middle-income countries. Vaccination has been shown to be an effective preventive strategy in controlling typhoid fever, though there are only two vaccines prequalified by the WHO at this time. IVI is working with vaccine manufacturers around the world to make more TCVs available in the public market.