As the SAT1 topotype III strain of foot-and-mouth disease (FMD) continues to spread across Southern Africa, the Middle East, Europe and Asia, veterinary authorities and livestock producers face increasing pressure to strengthen prevention and outbreak preparedness strategies. The virus’s rapid evolution, combined with the severe economic impact of outbreaks, makes access to scientifically validated vaccines a critical component of disease control programs.
A foot-and-mouth disease outbreak has devastating economic consequences, including the closure of export markets, mandatory quarantines, restrictions on animal movement, and estimated losses of between USD 2.000 million and USD 5.000 million per affected country, according to the World Organisation for Animal Health (WOAH).
In this context, a heterologous challenge study conducted by Wageningen Bioveterinary Research validated that BIOAFTOGEN® SAT1, a vaccine produced by the Argentine company Biogénesis Bagó, provides 100% protection against the SAT1 topotype III strain when administered in a two-dose schedule, and 86% protection with a single dose. This result constitutes the first independent global validation of cross-protection against the pandemic variant SAT1 topotype III, which is currently circulating in multiple regions of the world.
The findings are particularly relevant because the vaccine was evaluated against the SAT1/LEB/8/2025 strain (topotype III), a viral variant different from the one used in its manufacture. The results therefore demonstrate effectiveness against the genetic diversity circulating in endemic regions. For governments, veterinarians and livestock producers in Africa, the Middle East and Asia, where SAT1 foot-and-mouth disease continues to pose an active threat, the study provides scientific validation of a reliable disease-control tool backed by rigorous independent testing.
The vaccine’s high potency, previously confirmed in more than 128 PD50 in trials conducted at Wageningen University, proved decisive. While vaccine matching tests (R1 values) offer only indirect indicators of potential efficacy, challenge studies under controlled conditions continue to be the scientific gold standard for demonstrating protection under real-world conditions.
“These results provide governments, producers and organizations with a proven tool in the fight against foot-and-mouth disease,” said Rodolfo Bellinzoni, Biogénesis Bagó’s Scientific Director of Foot-and-Mouth Disease. “This is not just a scientifically validated vaccine; it is also backed by a company that has demonstrated its ability to respond to large-scale animal health emergencies and now has independent evidence of protection against the pandemic strain threatening the region.”
BIOGÉNESIS BAGÓ: EXPERIENCE FORGED IN CRISIS
Behind BIOAFTOGEN® SAT1 is Biogénesis Bagó, an Argentine company with more than 70 years of experience responding to foot-and-mouth disease outbreaks around the world. Its leadership has been consolidated through production and operational capabilities tested on numerous occasions, enabling it to supply world-class vaccines in record time for foot-and-mouth disease emergencies in Taiwan (1997), South Korea (2016) and Israel (2026), among other cases. A notable example occurred during Argentina’s foot-and-mouth disease epidemic in 2001, when the company produced and distributed more than 120 million doses of vaccine in just 11 months, helping to control the outbreak and enabling the country to regain foot-and-mouth disease-free status in record time.
Biogénesis Bagó is one of the few companies in the world capable of producing vaccines against all seven foot-and-mouth disease serotypes. This capability has enabled it to become a supplier to antigen banks for Brazil, the United States, Argentina, South Korea, Taiwan and Canada. Its combination of crisis management experience, technical expertise and independent validation of cross-protection against pandemic strain SAT1 topotype III makes it a strategic ally for regions where this variant continues to pose an active threat.
SCIENTIFIC VALIDATION BY A WORLD-RENOWNED LABORATORY
The study was conducted by Wageningen Bioveterinary Research, accredited as the Netherlands’ National Reference Laboratory for notifiable animal diseases and certified by AAALAC for compliance with international animal welfare standards. The laboratory is also approved by FAO/WOAH for the validation of biological products.
WHY HETEROLOGOUS CHALLENGE MATTERS
A homologous challenge demonstrates efficacy against the same virus used to produce the vaccine. A heterologous challenge is scientifically more demanding and much more relevant to real-world conditions, where viruses evolve continuously.
The results obtained by Wageningen demonstrate that BIOAFTOGEN® SAT1 is effective against the viral variants currently circulating in the affected regions. This is particularly significant for veterinarians and animal health authorities because it shows that the vaccine does not merely protect against a single viral isolate, but provides protection against the genetic diversity likely to be encountered in the field.
