Indonesia has granted marketing authorization for Bio-RV, a neonatal rotavirus vaccine resulting from a partnership between PT Bio Farma and the Murdoch Children’s Research Institute, potentially enhancing early protection for infants against severe diarrhoea.
Indonesia has granted marketing authorisation for Bio-RV, a neonatal rotavirus vaccine developed by PT Bio Farma and the Murdoch Children’s Research Institute, in a step both organisations say could strengthen protection for infants against one of the main causes of severe diarrhoea. Bio Farma said it received the green light from the Indonesian Food and Drug Authority, known as BPOM, on 2 September 2026, after years of research, clinical work, technology transfer and manufacturing preparation.
The vaccine is a live, attenuated oral product designed to prevent gastroenteritis caused by rotavirus infection. It is given in three doses, starting within the first five days of life, followed by doses at 8 to 10 weeks and 12 to 14 weeks. Bio Farma says the early schedule is intended to begin protection during the neonatal period, when families are already in contact with local health services.
Rotavirus remains a major public health concern in Indonesia. Citing Ministry of Health data from the Indonesia Rotavirus Surveillance Network covering 2001 to 2017, the companies say the virus was responsible for about 41% to 58% of diarrhoeal cases among children under five who needed hospital treatment. They also warn that repeated bouts of diarrhoea can interfere with nutrient absorption and raise the risk of growth problems.
Shadiq Akasya, Bio Farma’s president director, said the authorisation reflected more than a single product approval. Speaking in the company’s announcement, he described the project as the result of long-running collaboration between researchers, universities, industry and international partners, and said the aim was to protect Indonesian children earlier while helping secure a more reliable domestic vaccine supply.
The vaccine’s roots lie in RV3-BB, a candidate based on a neonatal rotavirus strain developed by MCRI. The institute says the science goes back to work in the 1970s and 1980s by researchers including Ruth Bishop, Ian Holmes and Yati Soenarto, who helped establish the importance of rotavirus in childhood diarrhoeal disease in Indonesia. Julie Bines later led the development of RV3-BB through clinical work in Australia, New Zealand and Indonesia.
Bio Farma said partners in the wider development effort included Universitas Gadjah Mada, Universitas Airlangga through the Airlangga Integrated Research Clinic, and PATH. The company said the project could help build Indonesia’s vaccine innovation ecosystem, reduce dependence on imports and support the long-term sustainability of the national immunisation programme.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
