The U.S. is planning a vaccine bank to guard against foot-and-mouth disease. Here is what you need to know:

Veterinarians, researchers and livestock industry leaders have long worried about the possibility of an outbreak of foot-and-mouth disease (FMD) in the United States. The highly contagious viral disease can affect cattle, pigs, sheep, goats and other animals with divided hooves.

Globalization, international travel and foreign animal disease outbreaks have heightened concerns about FMD in the U.S. even though the virus has not been seen on U.S. soil since 1929. Foot-and-mouth disease does not affect people, but an outbreak could severely disrupt the food supply and cause billions of dollars in damage and losses to the agricultural industry.

The U.S. Congress responded to those concerns by passing a Farm Bill in December 2018 that sets aside money for an animal vaccine bank with an emphasis on FMD vaccine. In July 2020, the U.S. Department of Agriculture (USDA) awarded Boehringer Ingelheim a contract to help supply a vaccine bank that will protect U.S. livestock from FMD.

Boehringer Ingelheim is an industry leader in fighting FMD, with over 70 years of expertise. It has the world's largest vaccine portfolio against multiple FMD serotypes and strains that circulate in parts of the Middle East, Asia, Africa and South America.

Boehringer Ingelheim also has the ability to formulate new vaccines to combat novel or emerging strains.

The Veterinary Public Health division at Boehringer Ingelheim Animal Health is the global leader in the storage and management of FMD vaccine banks, maintaining 17 banks for various countries and organizations.

Here is a look at some common questions and answers about foot-and-mouth disease and plans for a vaccine bank.

What is foot-and-mouth disease, and what are its effects?

Foot-and-mouth disease is a highly contagious viral disease of wild and domesticated animals with divided hooves, most notably livestock such as cattle, pigs, and sheep. It does not affect humans, but it could affect our food supply and have a devastating economic impact on the livestock industry.

What is a vaccine bank? How does it help fight FMD?

A vaccine bank is a strategic reserve of frozen vaccine antigen concentrate that a company can quickly formulate into a vaccine in the event of a disease outbreak.

The terms "vaccine bank" and "antigen bank" often are used interchangeably. The antigen in an FMD vaccine is the active ingredient, the substance that triggers an immune response.

Because FMD has such broad potential economic impact, governments typically manage disease-control efforts and programmed use of vaccines. Many countries own FMD vaccine banks to allow for a rapid response. Should an outbreak occur, they can use antigen concentrate to produce finished vaccine in a week or so. Without an antigen bank stockpile, teams would have to produce new FMD vaccines from scratch. That would allow FMD to spread faster than a company could make vaccine.

What experience does Boehringer Ingelheim have with vaccine banks?

Boehringer Ingelheim is the world leader in managing FMD vaccine banks. The company maintains 17 FMD banks for various countries and organizations.

For more than 10 years, Boehringer Ingelheim's Veterinary Public Health business unit has worked to align the company's capabilities with the mission of USDA. It also has raised awareness with livestock producer groups and industry stakeholders on the need for greater foreign animal disease preparedness in the U.S.

What kinds of vaccines against FMD are currently available?

There are seven distinct families, or "serotypes," of the FMD virus and more than 60 sub- types, or "strains.” Scientists make vaccines to match a serotype and, often, a sub-type, to stimulate an active immune response in the vaccinated animal. It is common to create FMD vaccines that are polyvalent, containing several strains in a single dose.

With legacy FMD expertise going back more than 70 years, Boehringer Ingelheim leads the industry in fighting this disease.

Boehringer Ingelheim’s FMD vaccines are formulated to be DIVA—"Differentiating Infected from Vaccinated Animals." This means that diagnostic tests can distinguish whether an animal's immune response comes from a vaccine or from disease infection. The distinction is critical in monitoring an outbreak and returning a country to "FMD-free" status.

Why doesn't the FMD vaccine bank store finished vaccines?

Finished FMD vaccines have a shelf life of only one year, whereas frozen antigen concentrate can be stored for many years. It is not efficient or cost-effective to preemptively formulate and store vaccines that may not be used, especially since it is impossible to predict what viral strains may arise. Banking antigen allows the flexibility to formulate finished vaccines as needed for the specific FMD strains of any particular outbreak.

How does FMD affect animals?

The FMD virus can cause painful sores around the mouth, hooves, and mammary glands. It also causes fever. While it is usually not life threatening (other than to the very young), it affects animals' growth and health enough to impede meat and milk production. Even animals that recover fully rarely return to pre-disease levels of productivity.

Learn more: FMD Factsheet from USDA Animal and Plant Health Inspection Service (APHIS)

Why is FMD such a threat to livestock industries and economies?

The FMD virus spreads easily and rapidly, with the potential to cause major economic damage and losses. Total costs can be hard to calculate because of the ripple effect that pork, beef, and dairy economies can have on other sectors in agriculture and beyond, such as tourism, trade, and employment loss in economic sectors supporting agriculture.

A highly publicized FMD outbreak in the U.K. in 2001 is estimated to have cost the country at least $6 billion, according to 2016 testimony to the U.S. House of Representatives by Iowa State University veterinary professor James Roth, DVM, PhD.

A major outbreak happened in South Korea in 2010/11, with an estimated impact of about $8 billion. Both these countries have much smaller agricultural economies than the U.S. and are less reliant on exports.

How has the U.S. been affected by FMD?

The last outbreak of FMD in the United States happened in 1929. Since then, the U.S. has maintained its status of "FMD-free without vaccination" as classified by the World Organisation for Animal Health (OIE).

Yet the threat of reintroduction is always possible, as the virus is widespread (i.e. endemic) in many parts of the world. Global travel and trade bring the risk of accidental introduction, and the possibility of intentional bioterrorism cannot be ignored. Once present, the FMD virus would spread rapidly because of the concentration and mobility of U.S. livestock production. As Professor James Roth's testimony noted, about 400,000 cattle and 1 million pigs are in transit daily.

What economic impact could an FMD outbreak have in the U.S.?

Loss of "FMD-free" status from an outbreak would shut down U.S. export markets. Most trade partners would refuse to accept animal protein or related agricultural imports from FMD-affected countries. The reason? Even processed meat can contain viable virus for a prolonged period, and pose the risk of infection to livestock exposed to it.

U.S. pork, beef, and dairy industries rely heavily on exports, valued at more than $19 billion in a 2017 estimate. An export embargo would lead to the loss of those revenues, and it would devalue domestic markets and affect poultry and grain prices. Agriculture is so significant in the U.S. that these effects would ripple into the general economy.

An uncontrolled FMD outbreak in the U.S. could cause economic losses of close to $200 billion across all economic sectors over 10 years, according to a 2011 study from the Center for Agricultural and Rural Development at Iowa State University.

An outbreak of FMD in the U.S. also would disrupt the food supply.

How is FMD treated, and how is an outbreak controlled?

There is no disease-specific treatment for FMD. Because infected animals lose production value even after recovery, preventing viral spread through vaccination is critical.

Non-endemic countries do not vaccinate for FMD preemptively. However, they must be prepared to act at the first sign of infection. The FMD virus is found in all bodily fluids, including milk, and spreads easily—not just through direct animal-to-animal contact, but also through human contact, contaminated equipment and materials, and even by air.

Vaccination protects animals from clinical illness, reduces viral shed, and slows disease spread.

Vaccination is only one tool in controlling an FMD outbreak. Equally critical are sanitary and quarantine measures; limits on animal movement; culling and safe disposal of infected and susceptible animals; and diagnostics to assess disease status on an ongoing basis.

How has the U.S. prepared for an FMD outbreak in the past?

Since 1982, the U.S. has shared the North American FMD Vaccine Bank with Canada and Mexico. Historically, these antigen reserves were held at the Plum Island Animal Disease Center. This federal-government-owned island off the coast of New York was established in 1954 as a bio-secure research laboratory to study contagious foreign animal diseases.

Authorities are decommissioning the Plum Island facility and replacing it with the National Bio and Agro- Defense Facility (NBAF) under construction in Manhattan, Kansas. It is expected to be fully operational in the next few years.

More than a decade ago, some in the United States maintained that an FMD outbreak could be addressed by culling animals on affected farms. This approach is outdated: in the event of an FMD outbreak in North America, vaccination will be essential to ensure business continuity for the livestock industry.

The existing North American FMD Vaccine Bank inventory is insufficient for anything beyond a very small, localized outbreak in the U.S. In March 2019, the Government Accountability Office (GAO) released a report detailing the country's vulnerability to an FMD outbreak. It notes that the current bank supply could only vaccinate about 14% of cattle in Texas or 4% of pigs in Iowa—far below national needs.

Given this shortage, livestock industry groups have long lobbied for funding to increase the stockpile. They see the 2018 Farm Bill provisions as an important step in the right direction.

What is the U.S. Farm Bill, and what does it have to do with FMD control?

The Farm Bill covers a wide variety of programs and provisions relating to farming and food production, which the U.S. Department of Agriculture (USDA) implements.

The 2018 Farm Bill, formally titled the "Agricultural Improvement Act of 2018," is an $867 billion package that the president signed into law on December 20, 2018. It allocates $150 million toward improving the USDA's preparedness for animal disease threats over the next five years, with the potential for additional future funds as needed.

The bill created a new, U.S.-dedicated National Animal Vaccine and Veterinary Countermeasures Bank, with FMD vaccine as its first priority. Other funds support the National Animal Disease Preparedness and Response Program, to boost the nation’s efforts to keep high-consequence animal diseases from entering and spreading in the United States, and the National Animal Health Laboratory Network (NAHLN), which provides diagnostic services. The bill also included funding for states, universities and other partners to help combat an animal disease outbreak.

What lies ahead in the fight against FMD?

The pork, beef, dairy, and animal health industries continue to work to keep FMD in the spotlight.

With no end in sight to the global FMD threat, Boehringer Ingelheim continues to build out production capacity and explore new vaccine technologies in the fight against this ongoing threat.

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