Bio Farma receives BPOM approval for neonatal rotavirus vaccine Bio-RV

PT Bio Farma (Persero), in collaboration with the Murdoch Children’s Research Institute (MCRI), has received marketing authorization from the Indonesian Food and Drug Authority (BPOM RI) for Bio-RV, a neonatal rotavirus vaccine. The authorization was issued on September 2, 2026, following extensive research, clinical trials, and technology transfer processes.

Bio-RV is an orally administered, naturally attenuated live vaccine designed to prevent acute gastroenteritis and severe diarrhea caused by rotavirus infections. The vaccine is administered in three doses: the first at 0–5 days of age, the second at 8–10 weeks, and the third at 12–14 weeks. This schedule allows for protection to be established during the neonatal period.

Rotavirus remains a leading cause of severe diarrhea in infants and toddlers. According to data from the Indonesia Rotavirus Surveillance Network, rotavirus was responsible for approximately 41% to 58% of hospitalized diarrhea cases among toddlers between 2001 and 2017.