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16 December 2002
Correspondence with UBI: FMD vaccines and diagnostic tests
E-mail from Dr James Irvine to Ms Volz, United Biomedical Inc.
Tuesday 10th December 2002
Dear Ms Volz
Further to my e-mail to you this morning, I have
obtained on online version of the recent paper by Chang via Edinburgh
University.
I have reviewed OIE statements but I am still
somewhat confused about the position of exporting FMD vaccinated
animals. Diagnostic tests and immunosurveillance are I believe based
on using them on a herd basis. Do they really apply now to the export
of live vaccinated animals? Presumably other additional criteria
apply. I would be grateful if you could elaborate on this. To use
diagnostic tests and vaccines relevant to an individual animal for
live export would presumably mean that both the vaccine and the
tests had been fully validated, which as far as I know has not happened
and with the rate at which things go within OIE is on a never never
timescale. What are the problems of validation that has now been
talked about for years?
Again, I would be most grateful for your help
Regards,
Dr James Irvine FRSE
Response from Alan Walfield, United Biomedical Inc.
Monday 16 December 2002
Dear Dr Irvine
You are quite correct about test validations.
The OIE has endorsed the concept of using NSP tests on vaccinated
animals for purposes of export control without approving of any
particular test, or even establishing standards for NSP tests.
The vaccine side of things is better. The OIE
now specifies that along with specifications for potency and safety,
vaccines are to be free of NS proteins, and our own in-house testing
shows this to be so for the major brands of vaccines. Therefore,
once NSP tests have been validated (which may be in our lifetimes,
see below), compatible NSP-free vaccines will allow for the reliable
immunosurveillance of vaccinated animals. Help is now on the way
for a pathway to validation of NSP tests. There was a meeting last
month in Vienna organized by the International Atomic Energy Agency/FAO
group who have been working to standardize NSP tests for developing
countries. It was attended by representatives from the USA, Canada,
several EU members, and the IAEA lab and contract-holders working
with NSP tests. The agenda was to set up a uniform standard for
the validation of NSP tests, including setting up uniform panels
of reference sera. UBI has already been involved with this process
through our interactions with the IAEA's testing program. The plan
is that a standard reference panel of sera will be used against
which commercial NSP tests will be evaluated in parallel, by several
reference labs. Out of this testing, they will set standards for
sensitivity and specificity, and deal with the question whether
the NSP tests can be validated as tools for evaluating individual
animals or herds. Presumably, those standards will then be incorporated
by the OIE. The issue of whether or not the NSP diagnostics can
be used to evaluate vaccinated animals for export is cause for debate.
More usefully, reference sera panels are being set up to include
sera from vaccinated-carrier animals to answer this question. Please
note that as a company, we do not participate in the meeting where
the advisory groups decide on standards.
Regards
Alan M Walfield, Ph.D.
United Biomedical, Inc
Related Articles on Land-Care
UBI Press Release, 9 December 2002. Success at Long Last: Development
of a Safe Synthetic Vaccine for Foot-and Mouth Disease by United
Biomedical, Inc. (UBI). (Click
here to view).
Irvine, W. J. (2002). Editorial - UBI FMD Vaccine Advance. (Click
here to view).
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