Novel vaccine for foot-and-mouth disease in cattle shows full protection in clinical trial

A clinical trial assessing the efficacy of a new vaccine for foot-and-mouth disease (FMD) in cattle has demonstrated success. The research, which was conducted by the Friedrich Loeffler Institute—the Federal Institute for Animal Health of Germany in Greifswald—found that all the animals who were vaccinated with the novel vaccine were fully protected and showed no signs of viral shedding or adverse effects.¹

According to the US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), FMD is a serious and highly contagious viral disease that affects cows, pigs, sheep, goats, deer, and other animals with divided hooves. Impacted animals may exhibit fever and blisters on the tongue, lips, in and around the mouth, mammary glands, and around the hooves. The blisters will then cause erosions, which can lead to depression, anorexia, excessive salivation, lameness, and reluctance to move or stand. Additional symptoms include²:

• Sticky, foamy, stringy saliva
• Abortions
• Low milk production in dairy cows
• Heart disease and death, particularly in newborns

Although the disease is typically not fatal, infected animals are typically left weakened and will no longer be able to produce milk the way they did prior to infection.²

Photo: EcoView/Adobe Stock

According to the USDA APHIS, the disease is global concern and poses a risk of introduction into the United States.² Recently, Europe has observed outbreaks of FMD in its cattle population. In certain parts of Africa, Asia, and the Middle East, the disease is endemic.

In affected areas, the viral disease also causes significant economic losses.^1,2 “FMD is present in countries near to Australia and is front of mind for industry in terms of potential biosecurity risks," said Michael Crowley, Meat & Livestock Australia managing director, in a news release.¹

The vaccine for FMD in cattle was developed by Tiba Biotech, a preclinical stage biopharmaceutical company that develops next-generation RNA vaccines and therapeutics revolving around a new dendrimer nanoparticle delivery platform—a type of vaccine delivery system that uses dendrimers (tree-like synthetic molecules) to carry RNA into cells. The system was initially invented by the Massachusetts Institute of Technology and the Whitehead Institute for Biomedical Research in Cambridge, Massachusetts.

Additionally, the vaccine’s creation formed part of an international research partnership involving the Elizabeth Macarthur Agricultural Institute and the RNA Institute at the University of New South Wales. Moreover, the New South Wales Department of Primary Industries and Regional Development as well as Meat & Livestock Australia provided support.

For the study, researchers investigated humoral immune responses and the vaccine’s ability to protect animals when directly intentionally exposed to the virus. According to Tiba, the trial’s success builds on previous livestock vaccine research, which received support from the Bill and Malinda Gates Foundation and Canada’s International Development Research Centre.¹

"Today we are excited to contribute to the future of animal health with this next-generation solution," Peter McGrath, Tiba co-founder who heads Australian operations, said in a news release.¹ "Our focus now shifts to working closely with regulators to ensure the vaccine meets the highest standards of safety and effectiveness, and ultimately to make this breakthrough available to the farmers and producers who need it most."

In addition to the FMD vaccine, Tiba has also developed human vaccine and therapeutic candidates. Recently, the organization has made progress in lung disease therapeutics.

Tiba’s RNA delivery platform, RNABL, uses biodegradable nanoparticles that naturally degrade after they deliver an “immune-triggering” RNA payload. The company’s vaccine platform can also be stored in at a standard refrigeration temperature long term and at room temperature for up to a month,¹ posing a contrast to other current mRNA vaccines, which often require colder storage temperatures.

According to Tiba, the FMD vaccine still has to go through a strict evaluation process with animal health regulators until it can be made commercially available.

References

1. Tiba's novel foot-and-mouth disease vaccine provides full protection in cattle study. News release. Tiba Biotech. August 4, 2025. Accessed August 5, 2025. https://prnmedia.prnewswire.com/news-releases/tibas-novel-foot-and-mouth-disease-vaccine-provides-full-protection-in-cattle-study-302520704.html
2. Foot-and-mouth disease. US Department of Agriculture Animal and Plant Health Inspection Service. Accessed August 5, 2025. https://www.aphis.usda.gov/sites/default/files/fs-fmd-general.pdf