New York Daily

The United Biomedical F&M Story
by Michael Unger
Staff Writer

Four years ago, while visiting her native Taiwan, Chang Yi Wang saw firsthand the devastation foot-and-mouth disease can cause when an outbreak there prompted the government to destroy more than 4 million pigs.

"I witnessed the burning of these animals, and the digging of ditches for mass graves in the countryside," Wang recalled last week. "It was like a war."

Now, in the midst of a global scare over recent outbreaks in England and Europe, the Long Island biotech firm headed by Wang is being looked to by the U.S. Department of Agriculture and 18 other countries -- the latest being Germany, which called Wang on Wednesday -- as, potentially, a major arms supplier in that war.

United Biomedical Inc. of Hauppauge is testing use of an experimental synthetic vaccine that early results suggest could protect animals without the need to turn to conventional vaccines, which use weakened forms of the virus itself to promote production of protective antibodies.

The synthetic vaccine is needed, Wang said, because traditional vaccines can sometimes result in infection, which makes them "a biohazard for both production and use." Additionally, she said, "it has not been possible to distinguish vaccinated animals from infected animals by standard immunoassays [blood tests]" since both carry disease antibodies.

For that reason, vaccines have not been used in most countries, including the United States, where the disease -- which is considered the most infectious of all animal diseases, but which is harmless to nearly all humans -- has not been seen since 1929. In the United States, the vaccine cannot legally be handled outside of a top-level biohazard facility.

Wang's designer vaccine, which is the only synthetic vaccine close to licensing, is constructed using genomic guidelines to duplicate the chemical structure of the virus in a vaccine that, basically, fools the body into fighting a non-existent enemy.

The experimental vaccine has already proved effective in tests on six pigs at the U.S. Department of Agriculture's high-containment laboratory on Plum Island, said Fred Brown, an animal disease expert who helped conduct the studies. The company also has reported similar results in all but one of about three dozen pigs studied in Taiwan. 

The vaccine began protecting the animals within weeks to a month of its use, company officials said, and is designed to be used with tests developed by the company that are able to differentiate between vaccinated animals and sick ones. It's unclear how long the animals will remain protected.

Last week, the company and the USDA agreed to expand the studies by jointly testing the vaccine further in cattle and sheep, according to Roger Breeze, associate administrator of the USDA's animal research service, which runs Plum Island's high-containment laboratory.

Once these animals are vaccinated using the synthetic formula, the animals would be "challenged" with the most prevalent foot-and-mouth disease strain of the virus, dubbed Type O.

While seven serotypes, or forms, of the disease are known to exist, Wang has said the firm "can quickly synthesize designer vaccines according to the viral genomic sequences. So, even in the face of an attack by a virus of unexpected serotype, we can keep ahead of the virus for protection of the animals."

The USDA, Breeze said, "believes it is in the U.S. national interest to expedite cooperative studies to extend the data to cattle and sheep and to complete whatever swine studies may still be needed."

Meanwhile, Wang, who serves as United Biomedical's president and chief executive, said that in recent weeks she's been contacted by 18 countries seeking information and test kits.

United Biomedical, which was founded in 1985 and remains a private firm, "anticipates accelerating registration and testing of our vaccine and diagnostics, so the effort can quickly become part of the official U.S. program" for controlling the disease in the event of an outbreak here, said Wang, a highly regarded immunologist and biochemist who received her doctorate from Rockefeller University and is a former head of immunology at Memorial Sloan-Kettering Cancer Center in Manhattan.

Wang said last week that her company is beginning to stockpile 5 million to 10 million doses of the key amino acid ingredients needed to create the vaccine. And within 9 to 12 months, Wang added, United Biomedical is planning to produce 25 million "finished" vaccine doses.

Breeze, a former Plum Island director, said he has also asked the USDA's Animal and Plant Health Inspection Service to expedite United Biomedical's efforts to obtain necessary licensing and approvals once the results of the new tests are known.

"At this time, when everyone's concerned about the disease in Europe, we just would like to have the option of a peptide vaccine available to the U.S.," Breeze said. "It's our job to have the option. I'm not saying we'd use it; that would depend on the situation and how extensive an outbreak might be. But it's better to have a vaccine."

An outbreak of foot-and-mouth disease -- which causes extremely painful blisters to form around the mouth and feet, prompting animals generally to refuse food and water -- could be particularly dangerous in New York, the country's No. 3 dairy state, with $1.5 billion in annual sales of raw milk.

There are roughly 700,000 dairy cows in the state, according to Peter Gregg, spokesman for the Northeast Dairy Producers Association.

"Our farmers are very concerned," Gregg said Thursday. "We're appreciative of state and federal efforts to keep the disease out of the country. But if the disease ever did show up in North America, it could be devastating not only to the dairy industry but to the rural economy of New York."

Farmers, he said, "have hundreds of thousands if not millions of dollars invested in their individual herds. A top registered Holstein milk cow can fetch more then $5,000. And the disease is so incredibly contagious that a farmer could see his herd and his investment go poof overnight."

If an outbreak occurred without development of a useful vaccine, Gregg said, "what you would see would be pyres of burning carcasses just as you do now in England."

Indeed, in the last several months, foot-and-mouth disease has devastated livestock in England, Ireland, France and the Netherlands, where entire herds have been destroyed at great cost.

Last week, Wang confirmed the vaccine is being tested in Britain by a pharmaceutical partner she would not identify.

Copyright Newsday, Inc. Produced by Newsday Electronic Publishing.

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