What is UBI?

United Biomedical Inc.
(UBI)

United Biomedical, Inc. (UBI) headquartered on Long Island in Hauppauge, New York, is an international biopharmaceutical company with subsidiaries in Taiwan and China. The company has developed a platform technology utilizing antigen design for the development of vaccines and diagnostics.

UBI has been successful in developing synthetic peptide based HIV and Hepatitis C blood screening tests used worldwide.

Why did UBI get involved in Foot-and-Mouth Disease (FMD)? 

UBI got involved with the development of synthetic peptide based immuno-diagnostics and vaccines for Foot-and-mouth disease (FMD) in 1997 when Taiwan suffered a major FMD outbreak.

Another important factor for our involvement in FMD has been the encouragement and advice of Dr. Fred Brown, a well-known authority in the FMD field, who is now at USDA Plum Island Animal Disease Center (PIADC) just off Long Island here.

What about UBI FMDV vaccine? 

A synthetic vaccine is attractive because it is totally non-hazardous.

The idea of utilizing synthetic peptides for FMDV vaccines has been around for 20 years when a segment of the viral structural protein VP1 was found to elicit high titer antibodies that neutralize the virus. However, the earlier research work did not yield useful vaccines. 

UBI revisited the area in 1997. Over the past four years, we have applied our industrial product development skills, gone through hundreds of experimental groups in animal studies, to refine and come up with synthetic peptide vaccines which can be produced cost effectively on the scale of hundreds of millions of doses.

For now, we have vaccinated pigs, challenged them with infectious FMDV, and successfully protected almost all of them (45 of 46 animals) from viral infection and out-performed the commercial product. This has been done by four government laboratories on three continents.

The effect of the site-directed approach in vaccine design allows for better differentiation between infected and vaccinated animals.

How can UBI tests differentiate vaccinated animals from infected animals? 

The foot-and-mouth virus is made of structural and non-structural proteins. An infected animal will produce antibodies to both the structure and non-structure proteins. The current killed virus vaccines are manufactured by removing nonstructural proteins from the virus, so that the vaccine will elicit antibodies only to the structural proteins. 

UBI tests can specifically detect antibodies triggered by a nonstructural protein 3B and thus can distinguish vaccination from infection.

With the UBI tests, there would be no need to kill uninfected animals. And the tests provide a scientific solution for the surveillance and control of FMD. 

What are disadvantages of current FMDV vaccines? 

The current FMDV vaccines are killed virus vaccines, and they can be hazardous due to contamination by live viruses in the manufacturing process.

Vaccination can lead to a serological pattern that is very similar to natural infection, so it is difficult to tell the difference between infected and vaccinated animals by serum assays.

Current FMDV vaccines only offer narrow protection. That is the virus used in vaccine has to closely resemble the virus in circulation.

UBI solution:

The UBI FMDV vaccine is a synthetic subunit vaccine. No virus is used in its manufacturing, so it is absolutely safe.

The UBI synthetic FMDV vaccine triggers a serological response that is very different from the one induced by natural infections, so it can facilitate serological surveillance of natural infections.

The UBI designer synthetic vaccine offers broader cross protection against a wider range of virus strains. 

More importantly, in this age of genomics, we 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. 

Are UBI FMDV diagnostic kits commercially available now? 

Yes, the UBI diagnostic kits have been vigorously tested and validated, and they are manufactured in a GMP facility with strict quality assurance and quality control. The kits have been commercially available since 1999, and are currently sold worldwide through a USDA export license (except US domestic market).

How many tests can a technician perform in one day? 

In a clinical/reference laboratory such as a blood bank's viral antibody screening operation where ELISA plate washer, reader and automated sampling equipment are available, about 2,000 samples (i.e. about 20 plates) can be performed by one technician in a day. This output can be increased by more sophisticated automation.

How long does it take to collect blood samples from animals?

Collecting blood samples by skilled personnel takes about 5 minutes for a pig, 5-8 minutes for a sheep, and 10-15 minutes for a cow.

Is UBI FMDV vaccine commercially available now? 

No, it is not on the market yet. The vaccine has been tested in four countries including the US and Taiwan, and it has successfully protected almost all the vaccinated animals (45/46) from viral infection. The UBI FMDV vaccine is being registered for use in Taiwan. It will become generally available pending further trials and regulatory registrations.

What approach can a country adopt to scientifically manage and control FMD after the initial outbreak? 

Begin wide spread vaccination if the initial approach of stamping out the animals is beyond control. 

Stop the massive, blind killing, an antiquated practice in the age of modern vaccines and diagnostics. 

Quickly and extensively monitor and detect FMDV infections/carriers using UBI FMDV differential diagnostic tests.

Prevent disease spread by killing infected/carrier animals detected by the tests.

Continue to monitor progress toward FMDV eradication by using the diagnostic kits until reaching FMD free status.

Continue the widespread vaccination program until free of outbreaks for at least 24 months.

Why don't most of the world's industrialized countries who hold an FMD-free status vaccinate their livestock routinely with the current killed virus vaccine for FMD to prevent the outbreak of this highly contagious disease?

The short answers are that:

1. Traditional serological FMDV diagnostic methods cannot distinguish vaccinated animals from infected animals. Thus, they believe that vaccination will complicate their FMD-free status.

2. Vaccination using traditional killed virus vaccines may itself lead to disease outbreak, due to accidental contamination by live viruses during the vaccine manufacturing.

Once a nation has eradicated the disease from an area, thus gaining FMD-free status, not vaccinating the animals with the currently available killed virus vaccine allows the country to maintain a sensitive means of detecting whether the virus has crept back in again, as any accidental infection will lead to a full-blown outbreak.

However, this strategy of "non-vaccination" is a gamble. It assumes that the nation will be able to contain the outbreak by stamping out the infected herds quickly enough to prevent real damage and thereafter, in the absence of further outbreaks and vaccination, quickly regain its FMD-free status. 

Furthermore, the non-vaccination policies are based on the calculation that such outbreaks will happen rarely and be detected quickly so that this calculated vulnerability will be cheaper than the method of routine mass vaccination. 

Another concern for vaccination is that there was one case report which stated that in a few animals vaccinated with the killed virus vaccines, FMDV can still cause subclinical infection. It is not clear whether this can infect other animals, or how long such subclinical infection persists. The theoretical risk that this might have happened means meat from a vaccinated animal might be carrying the virus. Until now, standard tests could not distinguish whether an animal has antibodies to infection or to the vaccine. Other regions trying to remain FMD-free without vaccination will not buy meat from countries that vaccinate in case some vaccinated animals may harbor such subclinical virus. 

For the above reasons, the "FMD-free, non-vaccination" policy has been adopted by most of the industrialized nations in order to maintain their FMD-free status. 

From the world trade point of view, there is another benefit to the non-vaccination calculation. If a country does not vaccinate for FMD and other livestock diseases, that country can refuse imports from countries that have the disease, or that vaccinate. These vaccinating countries may be poorer countries with lower production costs, who may offer lower prices. Therefore, this "FMD-free, non-vaccination" policy can constitute an import barrier in today's world trade. 

The official statement from EU regarding why it does not vaccinate is that it must protect its exports to FMD-free countries. However, such exports only amounted to 5 per cent of total EU meat sales in 1999 (which reached $17 billion), prior to some import bans due to BSE. 

More than 78 per cent of meat sales in 1999 were domestic. If the "FMD-free, non-vaccinating" policy did not constitute an "IMPORT BARRIER", some of the domestic meat sales might have been lost to foreign competitors who vaccinate for FMD. 

The old practice in FMD control for the industrialized nations has run into challenges. In light of current situation, what is the risk-benefit calculation for non-vaccination?

In this, the age of the global village, the risks of non-vaccination are escalating as described below: 

1. The risk of accidental infection increases with global trade and travel; 

2. The risk of deliberate infection is considered non-negligible by many
intelligence agencies; and

3. Detecting an outbreak before it has spread far is made more difficult by
modern livestock stocking densities, centralized marketing practices and a
decline in veterinary surveillance. 

The current outbreak in Europe suggests not vaccinating may not be cheaper after all.

Why is it time for countries to eradicate FMD, then vaccinate and conduct active surveillance for infection?

This alternative strategy has only now become available. It is certainly the wisest policy for any government to adopt. In the short run it would be more expensive than not vaccinating and simply watching for outbreaks, but surely cheaper than Europe's current FMD disaster, both in terms of money and public opinion. In addition, surveillance technology could become cheaper and more reliable with modest investment. It is time for the international community to seriously weigh the new technological options for vaccinating versus the increased risks of not vaccinating.

Despite the EU non-vaccination policy, Belgium and the Netherlands have formally asked other EU countries to consider vaccinating routinely for FMD again. They have not said how this would be coupled with monitoring for subclinical infection. (Such routine prophylaxis must be clearly distinguished from the emergency vaccination permitted and now planned in the EU to contain outbreaks. All such emergency vaccinated animals must be destroyed before the region regains its disease-free status under current rules.)

Answers to the last few questions have incorporated the essay written by Debora MacKenzie, a European correspondent for New Scientist magazine.

What would the US do if FMD outbreaks occur there? Culling? No way! 

There are several arguments against mass culling which, when taken together, add up to making it an impossible task for USA, a country with a very high density of livestock in many states. 

First, mass culling policy dictates the killing of many adult animals which would otherwise have survived infection, albeit with perhaps a 10 percent loss in productivity. Despite this mass culling policy, a legacy of surviving but infectious animals are left behind, which would perhaps take years to eliminate in order for the USA to return to FMD-free status. 

Japan and South Korea account for over 60 percent of US beef and pork exports, and will ban imports of both from the US at the first report of a US outbreak. Australia and New Zealand will be happy to fill the gap. If US adopts a ring vaccination and selective culling policy, the outbreak will only result in a 10 percent loss in meat production as a result of an outbreak. This slight decrease in meat production will not affect the capacity to export to markets other than Japan and Korea.

Second, the logistics of slaughtering and disposing of possibly millions of head of livestock quickly overwhelms capacity. During the FMD outbreak in Taiwan in 1997, 4 million pigs were culled at a peak rate of 130,000 per day after the army got up to speed. Assuming the US Army could do the same on the larger US feed lots, it will still take 30 days to kill 4 million animals; 30 days in which the disease is still spreading. It is questionable, however, whether the public would stand for the spectacle of the US Army or National Guard shooting livestock. 

Third, the risk of delays due to litigation are great. Farmers and national associations of breeders would seek injunctions. Animal rights and environmental groups would do the same. Slaughtering could be held up for weeks. Also the substantial financial resources necessary for a big emergency would exceed existing provisions and require additional legislation, preceded by much debate, before being approved. Even emergency funds from the White House would take time to arrive. The general experience with public health authorities has been that they will always hope that the outbreak will be contained with minimum expenditure, inevitably leading to too little funding too late. There is no reason to believe animal health authorities will react differently.

Models exist that purport to show US conditions under the most optimistic circumstances. If culling of 95 percent of latently infected plus infectious herds can be achieved beginning in the second week after recognition of the first outbreak, "only" 20 percent of an affected region's herds need be destroyed to achieve control. But if culling to that level is delayed by just one week, the eventual destruction will have to be more than 90 percent. It is unlikely that any state agency will be able to move that fast, or be able to cull to that level.

Finally, a recent analysis of the potential cost of FMD in California projects direct costs, plus production losses, plus trade losses would sum to around US $8000 per head culled, or US $8 billion per million head - and this may be a conservative estimate. Twenty percent of the cattle in Texas alone is 1.6 million head.

References:

Ekboir J 1999. Potential impact of Foot and Mouth Disease in California. Agricultural Issues Center, Div Ag & Nat Res, Univ. Cal. Davis.

Yang PC, Chu RM, Chung WB, Sung HT 1999. Epidemiological characteristics and financial costs of the 1997 Foot and Mouth Disease epidemic in Taiwan. Vet Rec  145 (25): 731?734.

The above discussion on "why mass culling-as opposed to selective culling-although being used in the UK for the current outbreak is out of the question for the USA" is adapted from the contribution by Dr. Jack Woodall woodall@bioqmed.ufrj.br , originally appeared in www.promedmail.org on April 4, 2001. Dr. Jack Woodall's official affiliation is at: Dept. of Medical Biochemistry, Institute of Biomedical Sciences, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.

What can the US do to prevent FMD outbreak? Vaccination with the stockpiled killed virus FMD vaccine? 

The current policy of APHIS [US Department of Agriculture's Animal & Plant Health Inspection Service] dictates that the current killed virus-based FMD vaccine will only be used in the USA under 5 circumstances:

(1)	if an outbreak has not been contained within 6 months;
(2)	if it affects 25% of the livestock in a given area;
(3)	if the cost/benefit ratio of slaughter approaches 1:2;
(4)	if the disease becomes endemic in the wildlife of 3 or more states; or
(5)	if slaughter is found to be illegal.

Of course, as is happening in Europe, the policy on vaccination could change in the face of a crisis. But it will be a complete waste of time to argue the pros and cons of vaccinating in the USA when the disease reaches the continent.

The US stockpile contains 2.5 million doses of killed virus type O vaccine, the type that is causing the current pandemic. But there are 8 million head of cattle in Texas alone, not to mention sheep and pigs. Given the massive daily movements of livestock in the USA, and the time needed to vaccinate 2.5 million head, it would just be a diversion of scarce resources to attempt vaccination after the outbreak.

Even ring vaccination around outbreaks would be useless. The British experience has shown that by the time a new outbreak is detected, the disease has already spread far beyond that locality. And vaccination of a strip along the Mexican or Canadian border would not help. Cattle are no longer herded from one country to another; one truck crosses those borders every few seconds, and does not stop until it is far inside the USA.

It is time for US government to concentrate on other modern means of control before the pandemic arrives. Other than mass culling and vaccination with the killed virus FMD vaccine, UBI provides an alternative systematic approach for FMD control and eradication! 

The discussion above was adapted from the contribution by Dr. Jack Woodall woodall@bioqmed.ufrj.br , originally appeared in http://www.promedmail.org on March 29th, 2001.

See http://www.unitedbiomedical.com/qa.htm

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