Transboundary Animal Biologics, Inc.

Transboundary Animal Biologics Inc. (TABI) is a not-for-profit corporation, based in Ames, Iowa, USA with the mission of enhancing the availability of vaccines for transboundary animal diseases. Dr. James Roth established TABI in 2008 at the request of federal officials with the purpose of becoming a “permittee” for the “distribution and sale” of foot and mouth disease (FMD) vaccines in the U.S. At the time TABI was established, there were no FMD vaccines manufactured for use in the U.S. and no “permittees” for distribution and sale of foreign manufactured FMD vaccines. Federal officials recognized that without the ability to market a product in the U.S., foreign manufacturers would not invest the time or money to obtain a permit. A U.S. permittee (business in the U.S. or individual residing, or operating a business, in the U.S.) is required to assume legal responsibility for imported veterinary biological products (See Veterinary Services Memorandum 800.101).

Before establishing TABI, Dr. Roth, who is also a professor at Iowa State University (ISU), explored the possibility of becoming a permittee under the auspices of ISU. However, both ISU and federal officials requested that a not-for-profit organization be established instead. In February 2009, TABI received a nonprofit status as a 501(c)(3) organization from the Internal Revenue Service.

In 2008, TABI applied for funding from the Department of Homeland Security Science and Technology to cover costs for USDA Animal and Plant Health Inspection Service, Center for Veterinary Biologics (CVB) review and testing for BIOAFTOGEN®, a killed virus quadrivalent vaccine for foot and mouth disease (FMD) produced by Biogenesis Bago, Buenos Aires, Argentina. Testing of the vaccine was conducted at the USDA APHIS Foreign Animal Disease Diagnostic Laboratory (FADDL) on Plum Island, New York. Testing and documentation submitted to the USDA APHIS Center for Veterinary Biologics demonstrated that BIOAFTOGEN® meets the USDA requirements for purity, safety, potency and efficacy.

TABI received a permit for importation, distribution and sale of BIOAFTOGEN in July 2011. The vaccine may only be administered as directed by USDA-APHIS-Veterinary Services as part of an official USDA animal disease control program. If an FMD outbreak of one of the strains covered by this vaccine occurs, the USDA APHIS National Veterinary Stockpile (NVS) would work with Biogenesis Bago to obtain and distribute vaccine as needed. All vaccine purchase transactions would be between USDA and Biogenesis Bago. TABI would not receive any revenue for vaccine purchases. However, as the permittee, TABI must abide by CVB regulations and assumes legal responsibility for imported vaccine. The USDA has provided funding to enable TABI to cover the costs of maintaining the permit.

In 2010, DHS provided funding to TABI to work to become a permittee for a classical swine fever vaccine manufactured by Riemser, in Griefswald – Insel Riems, Germany. Riemser was later purchased by IDT Biologika, based in Dessau, Germany. TABI received the permit for importation and sale of this vaccine (Pestiporc) in June 2016. If an outbreak of classical swine fever occurs, the vaccine would be imported under the control of USDA and would be administered as directed by the USDA for use in a classical swine fever control program. TABI would not receive any revenue from vaccine purchases. However, as the permittee, TABI must abide by CVB regulations and assumes legal responsibility for imported vaccine. Funding for TABI to maintain the permit is part of an agreement between IDT and the NVS.

Dr. Roth meets with an ISU conflict of interest management committee regarding TABI activities annually and submits an annual conflict of interest report to ISU.

Dr. Roth has co-authored a document at the request of livestock commodity groups related to the need for an FMD vaccine stockpile for the U.S. (FMD Vaccine Surge Capacity for Emergency Use in the United States) and the USDA APHIS FAD PReP/NAHEMS Guidelines: Appendix A: Vaccination for Foot-and-Mouth Disease. Both of these documents are available at: 210-674-5237
He does not have any financial interest in any FMD vaccine or vaccine candidate.

Biogenesis Bago: 8053810644
IDT Biologika: /idt-biologika.com/en/

TABI President: James A. Roth, DVM, PhD, DACVM
TABI Vice President/Secretary: Jane Galyon, MS
Ames, Iowa USA
Phone: 515 294 8459
Email: TABI@transboundarybiologics.com