Email received September 13th from Dr Roger Breeze in response to the posting below
This APHIS study is a routine study looking only for any adverse effects from the vaccine itself - it is not a study of vaccine efficacy. Probably the investigators will collect serum from the animals before and after vaccination to see what levels of antibody are produced in a larger number of animals than has been possible in the lab so far.
But the efficacy standards for FMD vaccine are not based on measured levels of antibody - they are based on the ability of vaccinated animals to resist challenge with virulent FMD virus after vaccination - so the antibody data will have limited value.
As a result of the study there will be FMD antibody positive animals in the US food chain so APHIS needs to keep a tight regulatory handle on the animals to track them to slaughter.
This research stems from a US effort to invent a FMD vaccine that can be manufactured in the US without starting with live virulent FMD virus in a vaccine production plant. This is technically possible and has been for 20 years. The real issue is; so what?
All three items in this paragraph are possible today with existing vaccines and have been possible for 20 years.
- The world already has cheap and effective FMD vaccines and the challenge is to get the right vaccines administered in an organized and systematic way in developing countries so that these countries either eliminate FMD or have it firmly under control on a national and regional (between countries) basis.
- The developed countries at risk of deliberate attack with FMD viruses need an international policy that permits use of vaccine in outbreak response without adverse trade consequences and that is designed to deter terrorist attack by removing the unnecessarily punitive economic consequences.
- They also need adequate national and regional FMD vaccine banks sufficient to deter attack.
I am always in favour of better vaccines but in the case of FMD scientific data and discovery in epidemiology, diagnostics and vaccine technologies have not influenced national and international policy in 40 years.
It remains to be seen whether this adenovirus vaccine is as effective or more effective than current vaccines. Also whether it can do anything to dispel the dogma that surrounds vaccinated animals and the carrier state.
And finally there is the issue of vaccinating millions of food animals with a live genetically-engineered human virus - especially a human adenovirus from a family linked to cancer.
Again, the scientific facts of safety to humans and animals may not matter to the public long used to discounting science data: good luck explaining to the European public in an FMD emergency that the live human adenovirus vaccine for FMD will not cause FMD or cancer in people eating the meat!
I recollect that the beef industry was afraid to explain that the dead FMD vaccine would not adversely affect people eating the meat in 2001. It seems very unlikely that an adenovirus vaccine would displace the current FMD vaccines in countries where FMD is endemic because these countries already have access to good vaccines - and in any case the issue is not the efficacy of vaccines but the general lack of will to apply effective vaccination strategies!
Sorry to sound so negative in this. It is just part of the process that people who have a hammer see every problem as a loose nail.
The new Homeland Security people in 2002 knew nothing of agriculture and thought that a scientific discovery would be the solution. We have just eradicated FMD in South America - or very closely reached that point - with existing vaccines and with all the so called carrier animal problems etc. and with poverty, civil unrest and so on.
It was successful because finally governments and livestock owners got serious about using the tools that had been available for so long.
A new vaccine for US use will not change the world FMD situation because the US does not have FMD and does not buy vaccine - and FMD infected countries are not going to buy the US vaccine unless it has some extraordinary economic and efficacy attributes. Which it does not.
September 10th 2010 ~ "Because there is no live FMD virus in the vaccine, the field test presents no risk for a disease outbreak." USDA
Could this be the light at the end of the tunnel for which we have waited so long? "USDA Seeks Comments on FMD Vaccine" is a headline today on www.thepigsite.com which tells us that field tests for a foot and mouth vaccine are to be conducted in Michigan, Missouri and Nebraska. Animals are going to be vaccinated and observed for any side effects. "To determine whether to authorize shipment and grant approval for the field testing of this product, APHIS conducted a risk analysis to assess the potential effects of this product on the safety of animals, public health and the environment. As a result of this risk analysis, APHIS determined that there were no significant impacts expected. .."
"The US Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) is advising the public that it has released an environmental assessment for comment concerning authorization to ship and field test a foot-and-mouth disease (FMD) vaccine, live adenovirus vector.Of course, it is also true that the excellent FMD vaccines that have existed for years don't contain "live virus" either. (See warmwell.com's FMD vaccination pages)
The vaccine vector is replication-deficient and does not contain live FMD virus. ..."