Bio Farma receives marketing authorization for new rotavirus vaccine

PATH congratulates PT Bio Farma on receiving marketing authorization for its neonatal rotavirus vaccine, Bio-RV. This approval, granted by the Indonesian Food and Drug Authority (BPOM), means the vaccine meets established safety, efficacy, and quality standards and can be brought to market in Indonesia. It represents an important milestone in the country’s efforts to protect children from rotavirus and is the only rotavirus vaccine available in Indonesia manufactured by an Indonesian company—a crucial accomplishment for ensuring sustainable vaccine supply.

Rotavirus is a leading cause of severe diarrhea among children younger than five years of age, particularly in low- and middle-income countries. Indonesia’s Ministry of Health reports that, per the Indonesia Rotavirus Surveillance Network for 2001-2017, rotavirus was responsible for 41-58 percent of diarrheal cases among children under age five that required hospitalization. In young children, rotavirus can be deadly; it rapidly dehydrates the body, which can lead to electrolyte imbalances and organ failure. What’s worse, rotavirus is resistant to traditional diarrhea prevention strategies like handwashing and clean water supplies. Which means vaccination is the best—and only—reliable means of prevention.

While several globally available rotavirus vaccines have significantly reduced illness and deaths, bringing additional vaccine products to licensure is critical to improving affordability and ensuring a sustainable supply. Existing rotavirus vaccines are administered at the ages of 6, 10, and 14 weeks old, so a neonatal vaccine like Bio-RV offers additional protection during the first weeks of life.

PATH has been leading efforts to develop, accelerate, and support rotavirus vaccine development for more than 20 years. Through our Sustaining Vaccine Manufacturing (SVM) program, PATH supported Bio Farma in its efforts to secure marketing authorization for Bio-RV. For nearly four years, SVM has been providing chemistry, manufacturing, and controls (CMC) and quality technical assistance, including process improvements, resolving stability data gaps, potency assay improvement and validation, and gap assessments for the current and future manufacturing facilities used for Bio-RV. SVM continues to support Bio Farma’s manufacturing efforts as they move toward a commercial launch of Bio-RV in Indonesia.

Importantly, securing marketing authorization for Bio-RV marks not only the introduction of a new vaccine but also the strengthening of Indonesia's vaccine development and manufacturing capabilities.

Bio-RV is a live, naturally attenuated oral rotavirus vaccine that was developed through a collaboration between Bio Farma and the Murdoch Children’s Research Institute. The development journey encompassed research, process development, preclinical and clinical studies, technology transfer, registration, and manufacturing preparations, through collaboration with institutions, researchers, academia, industry, and global partners. Bio-RV is administered to infants in a three-dose schedule with the first dose given at 0-5 days of age; the second dose at 8-10 weeks; and the final dose at 12-14 weeks. Marketing authorization was granted on September 2, 2026.