PORTALJABAR, BANDUNG CITY - Republic of Korea and BANDUNG, Indonesia — The International Vaccine Institute (IVI) announced that Bio Farma's Bio-TCV typhoid conjugate vaccine (TCV) has received a distribution permit in Indonesia, after receiving approval from the Food and Drug Supervisory Agency (BPOM). as the drug and food regulatory authority in Indonesia.

Deputy Director General, Clinical, Assessment, Regulation, Evaluation IVI, Dr. Sushant Sahasrabuddhe said, with evidence that climate change and increasing antimicrobial resistance are impacting the prevalence and severity of typhoid fever, preventing the disease through vaccination is a key step for controlling typhoid.

"We are looking forward to the WHO PQ of Bio-TCV and its introduction to the global health market," said Sushant, in a press statement, Wednesday ( 8/11/2023 )

Bio-TCV is a Vi polysaccharide vaccine conjugated with diphtheria toxoid carrier protein (Vi-DT), which was initially developed at IVI and transferred to Bio Farma in 2014.

Since its inception, the scope of this joint vaccine development program has included preclinical development and Phase I-III clinical trials followed by technical support through local licensing and prequalification (PQ) submissions from the World Health Organization (WHO). This permit is intended for the Vaccine Alliance Company to purchase the vaccine for use in global public health use.

The decade-long partnership to develop a safe, effective and affordable TCV was funded in part by a grant from the Bill & Melinda Gates Foundation.

Bio Farma President Director Shadiq Akasya said that the licensing of the typhoid conjugate vaccine (Bio-TCV) from the Food and Drug Supervisory Agency (BPOM) was proof of Bio Farma's commitment to global health in fighting infectious diseases through providing safe vaccines.

"Bio TCV will undoubtedly be an important tool in the prevention of typhoid infection providing protection against this disease from the age of nine months," said Shadiq.

"The successful development of Bio-TCV is proof of Bio Farma's commitment to global health, fighting infectious diseases through providing safe and efficacious vaccines that meet international quality standards," he added.

IVI and Bio Farma confirmed the safety and immunogenicity of a single dose of Vi-DT and that it was not inferior to the TCV control that had met WHO requirements in phase III clinical trials in three provincial capitals in Indonesia. With the results of this research, BPOM approved the vaccine for use nationally in individuals aged nine months to 45 years.

Bio Farma will submit documents for WHO PQ, which if achieved will add an affordable TCV to the global public market that will be available to low-income countries through the Global Alliance Vaccine Initiative (GAVI).

Typhoid fever is a potentially life-threatening febrile illness caused by Salmonella typhi that primarily attacks children and young adults. According to WHO, it is estimated that there are 11 to 20 million typhoid cases each year, most of which occur in low and middle income countries.

Vaccination has been proven to be an effective preventive strategy in controlling typhoid fever, although there are only two vaccines that have been qualified by WHO at this time. IVI is working with vaccine manufacturers around the world to make more TCV available on the public market.