Frequently Asked Questions 
(FAQ)
	
	What is 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 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? 

To put into simple explanation: 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.

UBI solution:

We provide newly developed and validated diagnostic kits that can effectively differentiate between infected and vaccinated animals.

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 they are currently sold worldwide through a USDA export license (except US domestic market).

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 most of the world's industrialized countries do not vaccinate their livestock  for  FMD?

The short answer is that:

1.	Traditional serological diagnostic methods cannot distinguish vaccinated animals from infected animals. Thus, they believe that vaccination will complicate the situation.

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

More elaborately, because once you have eradicated the disease from an area, this is the most sensitive means of detecting whether the virus has crept back in again ‑ any accidental infection leads to a full‑blown outbreak.

However,  this strategy is a gamble assuming that  you  will be able to contain the outbreak by stamping out and  accomplish it  fast  enough to  prevent real damage. In the absence of further outbreaks  and  vaccination,  you  will  regain your FMD‑free status. 

Furthermore, non‑vaccination policies are based on the calculation that such outbreaks will happen rarely enough, and be detected soon enough, that this calculated  vulnerability  will  be  cheaper  than  vaccinating. 

Another major concern for vaccination is that in a few animals vaccinated with the killed virus vaccines, FMD virus can cause subclinical infection.  It is not clear whether this can infect other animals, or how long it persists. The theoretical risk that this might have happened means meat from a vaccinated animal might be carrying the virus and until now, standard  tests cannot distinguish whether an animal has made 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 it is harboring such subclinical virus. For the above reasons, the FMD-free, non-vaccination policy has been adopted by most of the industrialized nations and thus constituted an import barrier in today’s world trade.  

There is another benefit to add to the non‑vaccination calculation. If you don't vaccinate for FMD and other livestock diseases, you can refuse imports from countries that have the disease, or that vaccinate. These may well be poorer countries with lower production costs.

The EU says it does not vaccinate because it must protect its exports to FMD‑free countries, but these amounted to only 5 per cent of total EU meat sales in 1999 (which reached $17 billion), and that was before some import bans due to BSE.  But 78 per cent of meat sales that year were domestic. Some would surely be lost to foreign competitors who vaccinate for FMD, if the FMD‑free, non‑vaccination policy did not constitute an import barrier.

That at least is the official line established prior to the current FMD outbreak in UK. 

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

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.

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 don't countries eradicate diseases of concern such as 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.  It would be more expensive in  the short  run 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.

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