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From: TSS ()
Subject: CJD/TSE/BLOOD Amendment (Donor Deferral for Transfusion in France Since 1980) Issued: 8/8/2006
Date: August 8, 2006 at 11:57 am PST


Guidance for Industry
Amendment (Donor Deferral for Transfusion in France Since 1980) to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products"
DRAFT GUIDANCE
[PDF version]

This guidance is for comment purposes only.

Submit comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:www.fda.gov/dockets/ecomments. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

Additional copies of this draft guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448 or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at http://www.fda.gov/cber/guidelines.htm.

For questions on the content of this guidance, contact Dr. Sharyn Orton, Division of Blood Applications at 301-827-3524.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research
August 2006


--------------------------------------------------------------------------------

Table of Contents

INTRODUCTION
BACKGROUND
RECOMMENDATIONS
IMPLEMENTATION
REFERENCES

--------------------------------------------------------------------------------

Contains Nonbinding Recommendations

Draft - Not for Implementation

Guidance for Industry
Amendment (Donor Deferral for Transfusion in France Since 1980) to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products"

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

INTRODUCTION
This draft guidance, which we are issuing as a level I guidance, is intended to amend the "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products" (CJD/vCJD guidance), dated January 2002 (Ref. 1), by adding a donor deferral recommendation for donors who have received a transfusion of blood or blood components in France since 1980. After we review comments received on this draft guidance, we will amend the CJD/vCJD guidance by incorporating this donor deferral recommendation, update any outdated information, and reissue the revised CJD/vCJD guidance as a level II guidance document for immediate implementation.

This draft guidance applies to Whole Blood and blood components intended for transfusion, and blood components intended for use in further manufacturing into injectable products, including recovered plasma, Source Leukocytes and Source Plasma. Special provisions apply to donors of blood components intended solely for manufacturing of non-injectable products (see section III). Within this document, "donors" refers to donors of Whole Blood and blood components and "you" refers to blood collecting establishments.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.

Return to Table of Contents

BACKGROUND
Since the publication of the CJD/vCJD guidance, we have learned of additional information warranting revision to the guidance to address a possible increased risk of vCJD transmission from individuals who have been transfused in France since 1980. This revision is based on (1) the likelihood of exposure to the Bovine Spongiform Encephalopathy (BSE) agent in that country and (2) the recent documentation of three presumptive cases of transfusion-transmitted vCJD infection in the United Kingdom (U.K). As of August 1, 2005, 14 definite or probable cases of vCJD have been reported in France ().

Available data suggest that large amounts of U.K. beef exported to France during the peak years of the U.K. BSE epidemic constituted a substantial source of exposure in France to the BSE agent. An estimated 60% of U.K. bovine carcasses were exported to France (Ref. 3) accounting for approximately 6% of French consumption of beef products (Ref. 4). It is believed that the first recognized vCJD cases in France were infected by consuming imported U.K. beef because: 1) none of the individuals had lived in the U.K.; 2) the indigenous French BSE epidemic is relatively small and more recent than that in the U.K.; and 3) travels to the U.K. accounted for only 2% of the French total exposure to the BSE agent (Ref 3).

There have been a total of three presumptive cases of transfusion-transmitted vCJD, and all have been in the U.K. The first presumptive transfusion-transmitted case of vCJD by red blood cells was reported to the U.K. Parliament on December 17, 2003 (Ref. 5). A second presumptive case was reported in the U.K. in 2004 (Ref. 6). A third presumptive case was publicly announced by authorities in the U.K. in 2006 (Ref. 7).

On February 8, 2005, the Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC) discussed the available data and recommendations for deferral of U.S. donors transfused since 1980 in France and in other European countries. The TSEAC voted for deferral of blood donors who have received a transfusion of blood or blood components in France since 1980 but against deferral of Source Plasma donors with that same history. The TSEAC did not support deferral of blood donors or Source Plasma donors with history of transfusion in other European countries since 1980 (Ref. 8).

The incubation period for classical CJD may be as long as 38.5 years. Accumulating evidence suggests that the asymptomatic incubation periods of vCJD may be very long as well (sometimes exceeding 12 years from the time of exposure to the BSE agent), and blood collected as long as three years before otherwise healthy blood donors showed any sign of illness is presumed to have transmitted vCJD infection to recipients (Refs. 5 and 6). While the risk of dietary exposure to the BSE agent in France, as in the U.K. and other European countries, has almost certainly decreased in recent years thanks to successful efforts to control the BSE epidemic in cattle and to protect food from contamination with the BSE agent, an unknown but possibly significant number of blood donors might have already been infected in France during the peak years of the BSE outbreak in Europe. These considerations led FDA, consistent with the recommendations of the TSEAC, to conclude that it would be a prudent preventive measure to indefinitely defer blood donors who have received transfusions of blood or blood components in France since 1980. Laboratory studies using model TSE agents have demonstrated that TSE infectivity may be reduced by certain plasma fractionation manufacturing steps (Ref. 9). While experimental studies are reassuring, not all products have been thoroughly studied. In addition, it remains uncertain whether the models accurately reflect the form of infectivity in blood, which has not been characterized. Therefore, as an added safeguard and prudent preventive measure, we also recommend that Source Plasma donors who have received a transfusion of blood or blood components in France since 1980 be indefinitely deferred. However, we believe that blood components collected solely for manufacturing into non-injectable products (e.g., materials used in in vitro diagnostic test kits) need not be deferred. We will continue to monitor the BSE epidemic and re-evaluate the necessity of deferring donors transfused in other European countries.

Return to Table of Contents

RECOMMENDATIONS
You should indefinitely defer all donors who have received a transfusion of blood or blood components in France since 1980.

NOTE: Donors who are otherwise deferred based upon this recommendation should continue to donate if they are participating in a CBER-approved program that allows collection of blood components solely for use in manufacturing of non-injectable products. We recommend special labeling for products obtained from such donors (see section VII.A of the CJD/vCJD guidance).

All other recommendations from the CJD/vCJD guidance remain unchanged.

Return to Table of Contents

IMPLEMENTATION
We recommend that you implement this donor deferral recommendation within six months of the date that we finalize this draft guidance amendment. This draft guidance amendment will be finalized by reissuing the CJD/vCJD guidance inclusive of the amended language.

Return to Table of Contents

REFERENCES
FDA "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products", January 2002; http://www.fda.gov/cber/gdlns/cjdvcjd.htm.
http://www.invs.sante.fr/publications/mcj/donnees_mcj.html
Chadeau-Hyam, M. and A. Alperovitch, "Risk of Variant Creutzfeldt-Jakob Disease in France", International Journal of Epidemiology, 34(1):46-52, 2005.
Supervie, V. and D. Costagliola, "The Unrecognised French BSE Epidemic", Veterinary Research, 35(3):349-62, 2004.
Llewelyn, C.A., P.E. Hewitt, R.S. Knight, et al., "Possible Transmission of Variant Creutzfeldt-Jakob disease by Blood Transfusion", Lancet, 363(9407):417-21, 2004.
Peden A.H., M.W. Head, D.L. Ritchie, et al., "Preclinical vCJD After Blood Transfusion in a PRNP Codon 129 Heterozygous Patient", Lancet, 364(9433):527-9, 2004.
http://www.eurosurveillance.org/ew/2006/060209.asp
http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4088t1.doc
Foster, P.R., A.G. Welch, C. McLean, et al., "Studies on the Removal of Abnormal Prion Protein by Processes Used in the Manufacture of Human Plasma Products", Vox Sanguinis, 78:86-95, 2000.
http://www.fda.gov/cber/gdlns/cjdfrance.htm


INTRODUCTION
>>>This draft guidance, which we are issuing as a level I guidance, is intended to amend the "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products" (CJD/vCJD guidance), dated January 2002 (Ref. 1), by adding a donor deferral recommendation for donors who have received a transfusion of blood or blood components in France since 1980. After we review comments received on this draft guidance, we will amend the CJD/vCJD guidance by incorporating this donor deferral recommendation, update any outdated information, and reissue the revised CJD/vCJD guidance as a level II guidance document for immediate implementation.<<<

FRANCE ???

IT'S like the pot calling the kettle black, WHAT ABOUT THE USA ???

CJD WATCH MESSAGE BOARD
TSS
MAD COW BLOOD HUMANS RECALL (these are dime a dozen)
Mon Aug 7, 2006 10:24
71.248.132.189

PRODUCT
a) Red Blood Cells, Recall # B-1587-6;
b) Cryoprecipitated AHF, Recall # B-1588-6;
c) Recovered Plasma, Recal # B-1589-6
CODE
a), b) and c) Unit: 2016719
RECALLING FIRM/MANUFACTURER
Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on
March 13, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA and Germany

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;
b) Fresh Frozen Plasma, Recall # B-1591-6
CODE
a) and b) Unit: 2443595
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June
30, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;
b) Fresh Frozen Plasma, Recall # B-1593-6
CODE
a) and b) Unit: 2545596
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
December 14, 2004 and January 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


these usa mad cow blood for humans are a dime a dozen, the come out just
about every week ;

http://disc.server.com/discussion.cgi?disc=167318;article=2971;title=CJD%20WATCH


http://disc.server.com/discussion.cgi?disc=167318;article=2972;title=CJD%20WATCH


CJD USA

(please note steady increase in sporadic cjd from 1997 to 2004 with steady increase in type 'UNKNOWN' CJD? also, seems like they could come up with a better, more readable chart. ...TSS)


http://www.cjdsurveillance.com/resources-casereport.html


HUMAN and ANIMAL TSE Classifications i.e. mad cow
disease and the UKBSEnvCJD only theory

TSEs have been rampant in the USA for decades in many
species, and they all have been rendered and fed back
to animals for human/animal consumption. I propose that
the current diagnostic criteria for human TSEs only
enhances and helps the spreading of human TSE from the
continued belief of the UKBSEnvCJD only theory in 2005.
With all the science to date refuting it, to continue
to validate this myth, will only spread this TSE agent
through a multitude of potential routes and sources
i.e. consumption, surgical, blood, medical, cosmetics
etc. I propose as with Aguzzi, Asante, Collinge,
Caughey, Deslys, Dormont, Gibbs, Ironside, Manuelidis,
Marsh, et al and many more, that the world of TSE
Tranmissible Spongiform Encephalopathy is far from an
exact science, but there is enough proven science to
date that this myth should be put to rest once and for
all, and that we move forward with a new classification
for human and animal TSE that would properly identify
the infected species, the source species, and then the
route. This would further have to be broken down to
strain of species and then the route of transmission
would further have to be broken down. Accumulation and
Transmission are key to the threshold from subclinical
to clinical disease, and key to all
this, is to stop the amplification and transmission of
this agent, the spreading of, no matter what strain.
BUT, to continue with this myth that the U.K. strain of
BSE one strain in cows, and the nv/v CJD, one strain in
humans, and that all the rest of human TSE is one
single strain i.e. sporadic CJD (when to date there are
6 different phenotypes of sCJD), and that no other
animal TSE transmits to humans, to continue with this
masquerade will only continue to spread, expose, and
kill, who knows how many more in the years and decades
to come. ONE was enough for me, My Mom, hvCJD, DOD
12/14/97 confirmed, which is nothing more than another
mans name added to CJD, like CJD itself, Jakob and
Creutzfeldt, or Gerstmann-Straussler-Scheinker
syndrome, just another CJD or human TSE, named after
another human. WE are only kidding ourselves with the
current diagnostic criteria for human and animal TSE,
especially differentiating between the nvCJD vs the
sporadic CJD strains and then the GSS strains and also
the FFI fatal familial insomnia strains or the ones
that mimics one or the other of those TSE? Tissue
infectivity and strain typing of the many variants of
the human and animal TSEs are paramount in all variants
of all TSE. There must be a proper classification that
will differentiate between all these human TSE in order
to do this. With the CDI and other more sensitive
testing coming about, I only hope that my proposal will
some day be taken seriously. ...


TSS


Coexistence of multiple PrPSc types in individuals with

Creutzfeldt-Jakob disease


Magdalini Polymenidou, Katharina Stoeck, Markus
Glatzel, Martin Vey, Anne Bellon, and Adriano Aguzzi


Summary


Background The molecular typing of sporadic
Creutzfeldt-Jakob disease (CJD) is based on the size
and glycoform

ratio of protease-resistant prion protein (PrPSc), and
on PRNP haplotype. On digestion with proteinase K, type
1 and

type 2 PrPSc display unglycosylated core fragments of
21 kDa and 19 kDa, resulting from cleavage around amino

acids 82 and 97, respectively.

Methods We generated anti-PrP monoclonal antibodies to
epitopes immediately preceding the differential proteinase

K cleavage sites. These antibodies, which were
designated POM2 and POM12, recognise type 1, but not
type 2, PrPSc.

Findings We studied 114 brain samples from 70 patients
with sporadic CJD and three patients with variant CJD.

Every patient classified as CJD type 2, and all variant
CJD patients, showed POM2/POM12 reactivity in the

cerebellum and other PrPSc-rich brain areas, with a
typical PrPSc type 1 migration pattern.

Interpretation The regular coexistence of multiple
PrPSc types in patients with CJD casts doubts on the
validity of

electrophoretic PrPSc mobilities as surrogates for
prion strains, and questions the rational basis of
current CJD

classifications. ...


http://neurology.thelancet.com


J Neuropsychiatry Clin Neurosci 17:489-495, November 2005
doi: 10.1176/appi.neuropsych.17.4.489
© 2005 American Psychiatric Publishing, Inc.


Psychiatric Manifestations of Creutzfeldt-Jakob
Disease: A 25-Year Analysis
Christopher A. Wall, M.D., Teresa A. Rummans, M.D.,
Allen J. Aksamit, M.D.,
Lois E. Krahn, M.D. and V. Shane Pankratz, Ph.D.
Received April 20, 2004; revised September 9, 2004;
accepted September 13,
2004. From the Mayo Clinic, Department of Psychiatry
and Psychology,
Rochester, Minnesota; Mayo Clinic, Department of
Neurology, Rochester,
Minnesota. Address correspondence to Dr. Wall, Mayo
Clinic, Department of
Psychiatry and Psychology, Mayo Building-W11A, 200
First St., SW, Rochester,
MN 55905; wall.chris@mayo.edu (E-mail).

This study characterizes the type and timing of
psychiatric manifestations
in sporadic Creutzfeldt-Jakob disease (sCJD).
Historically, sCJD has been
characterized by prominent neurological symptoms, while
the variant form
(vCJD) is described as primarily psychiatric in
presentation and course: A
retrospective review of 126 sCJD patients evaluated at
the Mayo Clinic from
1976-2001 was conducted. Cases were reviewed for
symptoms of depression,
anxiety, psychosis, behavior dyscontrol, sleep
disturbances, and
neurological signs during the disease course. Eighty
percent of the cases
demonstrated psychiatric symptoms within the first 100
days of illness, with
26% occurring at presentation. The most commonly
reported symptoms in this
population included sleep disturbances, psychotic
symptoms, and depression.
Psychiatric manifestations are an early and prominent
feature of sporadic
CJD, often occurring prior to formal diagnosis.


snip...


CONCLUSIONS

Historically, psychiatric manifestations have been
described as a relatively
infrequent occurrence in the sporadic form of
creutzfeldt-Jakob disease.
However, our findings suggest otherwise. In this study,
a vast majority of
the cases were noted to have at least one psychiatric
symptom during the
course of illness, with nearly one-quarter occurring in
the prodromal or
presenting phase of the illness. After comparing the
frequency of
neuropsychiatric symptoms in sporadic CJD to studies
describing the variant
form of CJD, we found that there are fewer clinical
differences than
previously reported.5-7 While the age of patients
with vCJD presentation
is significantly younger and the course of illness is
longer, the type and
timing of psychiatric manifestations appear similar
between these two
diseases. ...snip...


http://neuro.psychiatryonline.org/cgi/content/abstract/17/4/489

Personal Communication


-------- Original Message --------


Subject: re-BSE prions propagate as

either variant CJD-like or sporadic CJD Date: Thu, 28
Nov 2002 10:23:43

-0000 From: "Asante, Emmanuel A" To:
"'flounder@wt.net'"

Dear Terry,

I have been asked by Professor Collinge to respond to
your request. I am

a Senior Scientist in the MRC Prion Unit and the lead
author on the

paper. I have attached a pdf copy of the paper for your
attention. Thank

you for your interest in the paper.

In respect of your first question, the simple answer
is, yes. As you

will find in the paper, we have managed to associate
the alternate

phenotype to type 2 PrPSc, the commonest sporadic CJD.

It is too early to be able to claim any further
sub-classification in

respect of Heidenhain variant CJD or Vicky Rimmer's
version. It will

take further studies, which are on-going, to establish
if there are

sub-types to our initial finding which we are now
reporting. The main

point of the paper is that, as well as leading to the
expected new

variant CJD phenotype, BSE transmission to the
129-methionine genotype

can lead to an alternate phenotype which is
indistinguishable from type

2 PrPSc.


I hope reading the paper will enlighten you more on the
subject. If I

can be of any further assistance please to not hesitate
to ask. Best wishes.


Emmanuel Asante

<> ____________________________________

Dr. Emmanuel A Asante MRC Prion Unit & Neurogenetics
Dept. Imperial

College School of Medicine (St. Mary's) Norfolk Place,
LONDON W2 1PG

Tel: +44 (0)20 7594 3794 Fax: +44 (0)20 7706 3272 email:

e.asante@ic.ac.uk (until 9/12/02)

New e-mail: e.asante@prion.ucl.ac.uk (active from now)

____________________________________


Full Text
Diagnosis and Reporting of Creutzfeldt-Jakob Disease
Singeltary, Sr et al.
JAMA.2001; 285: 733-734


http://jama.amaassn.org/cgi/content/full/285/6/733maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama

Freas, William

Monday, January 08,200l 3:03 PM

freas@CBS5055530.CBER.FDA.GOV

CJDIBSE (aka madcow) Human/Animal TSE’s--U.S.--Submission To Scientific Advisors and

Consultants Staff January 2001 Meeting (short version)

Greetings again Dr. Freas and Committee Members,

I wish to submit the following information to the

Scientific Advisors and Consultants Staff

2001 Advisory Committee (short version).

I understand the reason of having to shorten my submission,

but only hope that you add it to a copy of the long version,

for members to take and read at their pleasure,

(if cost is problem, bill me, address below).

So when they realize some time in the near future

of the 'real' risks i speak of from human/animal TSEs and

blood/surgical products. I cannot explain the 'real' risk

of this in 5 or 10 minutes at some meeting,

or on 2 or 3 pages, but will attempt here:

remember AIDS/HIV, 'no problem to heterosexuals in the U.S.?

no need to go into that, you know of this blunder:

DO NOT make these same stupid mistakes again with

human/animal TSE's aka MADCOW DISEASE.

I am beginning to think that the endless attempt to track

down and ban, potentia.1 victims from known BSE Countries

from giving blood will be futile. You would have to ban

everyone on the Globe eventually? AS well, I think we

MUST ACT SWIFTLY to find blood test for TSE's,

whether it be blood test, urine test, .eyelid test,

anything at whatever cost, we need a test FAST. ,

DO NOT let the incubation time period of these TSEs fool you.

To think of Scrapie as the prime agent to compare CJD,

but yet overlook the Louping-ill vaccine event in 1930's

of which 1000's of sheep where infected by scrapie

from a vaccine made of scrapie infected sheep brains,

would be foolish. I acquired this full text version of the

event which was recorded in the Annual Congress of 1946

ational Vet. Med. Ass. of Great Britain and Ireland.

" I rom the BVA and the URL is posted in my (long version).

U.S.A. should make all human/animal TSE's notifiable at all ages,

with requirements for a thorough surveillance and post-mortem

examinations free of charge, if you are serious about eradicating

this horrible disease in man and animal.

There is histopathology reports describing o florid plaques"

in CJD victims in the USA and some of these victims are getting

younger. I have copies of such autopsies, there has to

be more. PLUS, sub-clinical human TSE's will most definitely

be a problem.

SNIP...

THEN think of vaccineCJD in children and the bovine tissues

used in the manufacturing process, think of the FACT that

this agent surviving 6OO*C.

PNAS -- Brown et al. 97 (7): 3418 scrapie agent live at 600*C

Then think of the CONFIDENTIAL documents of what was known of

human/animal TSE and vaccines in the mid to late 8Os, it was all about

depletion of stock, to hell with the kids, BUT yet they knew.

To think of the recall and worry of TSE's from the polio vaccine,

(one taken orally i think?), but yet neglect to act on the

other potential TSE vaccines (inoculations, the most effective mode to

transmit TSEs) of which thousands of doses were kept and used,

to deplete stockpile, again would be foolish.

--Oral polio; up to 1988, foetal calf serum was used from UK and

New Zealand (pooled); since 1988 foetal calf serum only from New

Zealand. Large stocks are held.

--Rubella; bulk was made before 1979 from foetal calf serum from UK

and New Zealand. None has been made as there are some 15 years stock.

--Diphtheria; UK bovine beef muscle and ox heart is used but since the

end of 1988 this has been sourced from Eire. There are 1,250 litres of

stock.

. .

--Tetanus; this involves bovine material from the UK mainly Scottish.

There are 21,000 litres of stock.

--Pertussis; uses bovine material from the UK. There are 63,000 litres

of stock.

--They consider that to switch to a non-UK source will take a minimum of

6-18 months and to switch to a non-bovine source will take a minimum of

five years.

3. XXXXXXXXXXX have measles, mumps, MMR, rubella vaccines. These

are sourced from the USA and the company believes that US material only

is used.

89/2.14/2.1

============

BSE3/1 0251

4. XXXXXXXXXXX have a measles vaccine using bovine serum from the UK.

there are 440,000 units of stock. They have also got MMR using bovine

serum from the UK.

5. XXXXXXXXXXX have influenza, rubella, measles,' MMR vaccines

likely to be used in children. Of those they think that only MMR

contains bovine material which is probably a French origin.

6. XXXXXXXXXXX have diphtheria/tetanus and potasses on clinical trial.

hese use veal material, some of which has come from the UK and has been

ade by XXXXXXXXXXX (see above).

I have documents of imports from known BSE Countries,

of ferments, whole blood, antiallergenic preparations,

2

human blood plasma, normal human blood sera, human immune

blood sera, fetal bovine serum, and other blood fractions

not elsewhere specified or included, imported glands,

catgut, vaccines for both human/animal, as late as 1998.

Let us not forget about PITUITARY EXTRACT. This was used to help COWS

super ovulate. This tissue was considered to be of greatest risk of

containing BSE and consequently transmitting the disease.

ANNEX 6

MEETING HELD ON 8 JUNE 1988 TO DISCUSS THE IMPLICATIONS OF BSE TO

BIOLOGICAL PRODUCTS CONTAINING BOVINE - EXTRACTED MATERIAL

How much of this was used in the U.S.?

SNIP...FULL TEXT ;

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

TSS




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