Michelle Colby and the Vaccine Development Team

The outbreak of foot-and-mouth disease in the U.K. in 2001 and South Korea in 2011 resulted in the slaughter of millions of animals and huge economic losses for livestock and food industries.

Fearing similar severe consequences if the highly contagious animal disease were to appear in the United States, federal scientists worked for years to develop and win approval of a unique new vaccine to protect America’s cows, sheep and pigs.

The leader of the federal team that shepherded this livestock vaccine to licensure is Michelle Colby, a veterinarian and branch chief in the Homeland Security Advanced Research Projects Agency of the Department of Homeland Security (DHS).

The vaccine was created by research chemist Marvin Grubman of the U.S. Department of Agriculture’s Agricultural Research Service at Plum Island Animal Disease Center in collaboration with GenVec, a biopharmaceutical company. DHS colleagues Bruce Harper, John Neilan and others took the lead in further development and managed the research needed for the licensure process.

“This is the first ever foot-and-mouth vaccine licensed for manufacture in the United States. The breakthrough could potentially save the country billions if not trillions of dollars and save the lives of hundreds of thousands of animals if there were an outbreak,” said Paul Benda, director of the Homeland Security Advance Research Projects Agency.

The new vaccine has been shown to produce protective immunity in livestock and, in the event of an outbreak, would be administered to control transmission.

“This vaccine allows us to rapidly turn on the capability to limit the spread of the disease,” said Randolph Long of the DHS Chemical and Biological Defense Division.

The United States has been free from this serious animal disease since 1929 and has strict policies on trade of livestock and livestock products with countries that have experienced problems. While the virus typically spreads among infected animals, officials at DHS do not rule out the possibility that it could be intentionally introduced into U.S. livestock herds by terrorists.

Colby said she was drawn to the work by her desire to protect both animals and people, and “protecting the economy from agro-terrorism was a mission that I was uniquely qualified to undertake.”

“Since 9/11, DHS has been tasked with developing and accelerating countermeasures,” said Colby. “The vaccine is critical to our ability to be prepared.”

There have been other foot-and-mouth vaccines developed over the years, but they all carry risks because the production includes the use of the live virus. Federal law stipulates that no live foot-and-mouth disease virus may be introduced for research or manufacture in any part of the U.S. mainland because of the risks of contagion.

The Plum Island Animal Disease Center, near the northeast coast of Long Island in New York, is the only laboratory in the U.S. exempted from this law and is equipped with research facilities for this purpose.

The new vaccine, however, can be made domestically because it does not use the whole live virus and cannot replicate.

“This will allow us to manufacture the product in the United States and not have to go overseas for a vaccine,” said James Johnson, director of the DHS Office of National Laboratories. The United States currently keeps a vaccine stockpile for one strain of foot-and-mouth disease in the U.K.

Foot-and-mouth disease is one of the world’s most contagious animal viruses. When outbreaks occur, animals must be quarantined and are usually put down to avoid further spread.

The disease does not infect humans, but an outbreak among livestock could devastate the U.S. food industry, cost tens of billions of dollars and harm the economy. During outbreaks, the sale of meat and dairy products, including exports, is often stopped and public fear causes further erosion in the markets.

In pursuing the research and federal approval of the vaccine, Colby had to make the case for developing and licensing an emergency vaccine when there was no imminent emergency, make sure the resources were available and properly allocated for the endeavor, deal with the regulatory authorities, build consensus among the livestock groups and secure private-industry participation for the manufacture of the product.

Long said Colby “coordinated all the pieces of the puzzle” and was “instrumental in making it all happen.”

Colby said the new foot-and-mouth vaccine represents a major advance in the nation’s defenses, and is part of the arsenal now available to “protect our livestock and our economy if we do have an outbreak.”