• Project status: Active

Development of an oral rotavirus vaccine to protect babies from severe rotavirus gastroenteritis from birth

Despite this global progress, over 50 million infants still do not have access to a rotavirus vaccine. Barriers include cost, reduced vaccine efficacy in low‑income settings, and ongoing safety concerns.

To address these challenges, the oral RV3‑BB rotavirus vaccine was developed at Murdoch Children’s Research Institute (MCRI) with the goal of preventing severe rotavirus gastroenteritis from birth.

Despite this global progress, over 50 million infants still do not have access to a rotavirus vaccine. Barriers include cost, reduced vaccine efficacy in low‑income settings, and ongoing safety concerns.

To address these challenges, the oral...

Despite this global progress, over 50 million infants still do not have access to a rotavirus vaccine. Barriers include cost, reduced vaccine efficacy in low‑income settings, and ongoing safety concerns.

To address these challenges, the oral RV3‑BB rotavirus vaccine was developed at Murdoch Children’s Research Institute (MCRI) with the goal of preventing severe rotavirus gastroenteritis from birth.

Committed to reducing the global burden of rotavirus

Rotavirus was identified as the leading cause of severe diarrhoea in infants and young children by Professor Ruth Bishop and Ian Holmes at The Royal Children’s Hospital (RCH) and the University of Melbourne in 1973.

Since then, more than 134 countries have introduced a rotavirus vaccine into their national or regional immunisation programs.

Despite this global progress, over 50 million infants still do not have access to a rotavirus vaccine. Barriers include cost, reduced vaccine efficacy in low‑income settings, and ongoing safety concerns. To address these challenges, the oral RV3‑BB rotavirus vaccine was developed at MCRI with the goal of preventing severe rotavirus gastroenteritis from birth.

A new vaccine designed for global impact

The RV3‑BB vaccine is unique because it can be given in a neonatal schedule, offering protection from the earliest days of life. Clinical trials in Australia, New Zealand, Indonesia and Malawi have shown that RV3‑BB is safe, immunogenic and effective in both neonatal and infant dosing schedules.

In Indonesian infants, RV3‑BB demonstrated:

  • 94% protection against severe rotavirus disease at 12 months
  • 75% protection at 18 months
  • Strong immune responses when administered from birth

To ensure global accessibility, RV3‑BB has been licensed to emerging‑market vaccine manufacturers to support affordable production. Indonesian manufacturer PT BioFarma plans to introduce the RV3 vaccine into Indonesia’s national immunisation program in 2026/27, marking a major milestone in improving child health across the region.

Key publications

Bines JE, At Thobari J, Satria CD, Handley A, Watts E, Cowley D, Nirwati H, Ackland J, Standish J, Justice F, Byars G, Lee KJ, Barnes GL, Bachtiar NS, Viska Icanervilia A, Boniface K, Bogdanovic-Sakran N, Pavlic D, Bishop RF, Kirkwood CD, Buttery JP, Soenarto Y. Human Neonatal Rotavirus Vaccine (RV3-BB) to Target Rotavirus from Birth. N Engl J Med. 2018 Feb 22;378(8):719-730. doi: 10.1056/NEJMoa1706804. PMID: 29466164; PMCID: PMC5774175.

Witte D, Handley A, Jere KC, Bogandovic-Sakran N, Mpakiza A, Turner A, Pavlic D, Boniface K, Mandolo J, Ong DS, Bonnici R, Justice F, Bar-Zeev N, Iturriza-Gomara M, Ackland J, Donato CM, Cowley D, Barnes G, Cunliffe NA, Bines JE. Neonatal rotavirus vaccine (RV3-BB) immunogenicity and safety in a neonatal and infant administration schedule in Malawi: a randomised, double-blind, four-arm parallel group dose-ranging study. Lancet Infect Dis. 2022 May;22(5):668-678. doi: 10.1016/S1473-3099(21)00473-4. Epub 2022 Jan 20. PMID: 35065683; PMCID: PMC9021029.

Wagner J, Handley A, Donato CM, Lyons EA, Pavlic D, Ong DS, Bonnici R, Bogdanovic-Sakran N, Parker EPK, Bronowski C, Thobari JA, Satria CD, Nirwati H, Witte D, Jere KC, Mpakiza A, Watts E, Turner A, Boniface K, Mandolo J, Justice F, Bar-Zeev N, Iturriza-Gomara M, Buttery JP, Cunliffe NA, Soenarto Y, Bines JE. Early-life gut microbiome associates with positive vaccine take and shedding in neonatal schedule of the human neonatal rotavirus vaccine RV3-BB. Nat Commun. 2025 Apr 11;16(1):3432. doi: 10.1038/s41467-025-58632-6. PMID: 40210877; PMCID: PMC11986061.

Program funding

  • Gates Foundation
  • National Health and Medical Research Council (NHMRC)
  • Te Kāhui Tika Tangata Human Rights Commission (Nwe Zealand)
  • PT Bio Farma (Persero) - Indonesia

Program collaborations 

  • Universitas Gadjah Mada, Indonesia
  • PT BioFarma, Indonesia
  • University of Liverpool, UK
  • Malawi School of Medicine
  • University of Otago, New Zealand
  • Medicines Development for Global Health

More information

Contact us 

Professor Julie Bines
Lead RV3-BB Rotavirus Vaccine Program & Group Leader, Enteric Diseases 
Email:  

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