Diseases like MAD COW from MMR Vaccine?

1. Recombinant human albumin as protein source in culture media used ...

   may not eliminate prions which may transmit diseases like. Creutzfeldt-Jakob disease (CJD) ... genetically engineered to express the human albumin protein. ...
   www.ingentaconnect.com/content/repro/rebi/2002/00000004/00000003/art00006?crawler=true - Similar pages
   by M Bungum - 2002 - Cited by 5 - Related articles

2. IngentaConnect Recombinant human albumin as protein source in ...

   Recombinant human albumin as protein source in culture media used for IVF: a ... risks of prion contamination and transmission of plasma derived impurities. ...
   www.ingentaconnect.com/content/repro/rebi/2002/00000004/00000003/art00006 - Similar pages
   by M Bungum - 2002 - Cited by 5 - Related articles

3. The Journal of the American Society of Anesthesiologists, Inc ...

   There still exists an extremely remote possibility that some prion causing ... With the injection of human albumin, there is a possibility of inducing a ...
   www.anesthesiology.org/pt/re/anes/fulltext.00000542-200605000-00037.htm - Similar pages
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4. Albumin, human(Human Albumin) - NextBio

   Recombinant human albumin (rHA) is a highly purified animal-, virus-, and prion- free product developed as an alternative to human serum albumin (HSA), ...
   www.nextbio.com/b/home/home.nb?q=Human+Albumin - 63k - Cached - Similar pages

5. Mad Cows, Prions, and Wrinkles

   is from bovine material, especially inject-. able collagen. ..... identified for albumin. PREVENTION OF ACQUIRED. HUMAN PRION DISEASE (TSE) ...
   archderm.ama-assn.org/cgi/reprint/138/5/667.pdf - Similar pages
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6. [PDF]

   ALBUMIN (HUMAN) 25% SOLUTION, USP

   File Format: PDF/Adobe Acrobat - View as HTML
   ALBUMIN (HUMAN) 25% SOLUTION, USP must not be diluted with sterile water for. injection as this may cause hemolysis and acute renal failure in recipients ...
   www.talecris.com/ca/documents/Albumin_25percent_2006_104462.pdf - Similar pages
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Two million children innoculated with BSE vaccines

Daily Express May 2, 200 [minor edits by webmaster]

1. Smithkline's MMR (Measles, Mumps, Rubella), finally replaced "by end of 1992 approximately";

2. Wellcome's combined Diphtheria and Tetanus, last issued by the company in June 1991, with a June 1993 expiry date; 

3. Wellcome's DTP (Diphtheria, Tetanus, Pertussis) last issued again in June 1991, with a November 1993 expiry date; 

4. Wellcome's single component Diphtheria vaccine, last issued in October 1991, with a November 1993 expiry date; 

5. Wellcome's  Tetanus, last issued in December 1991, with a December 1993 expiry date.

6.[Wellcome's oral polio vaccine, last issue and expiry dates are "not known".

7. Smithkline's inactivated polio vaccine, apparently used only in foreigners.]

But a Department of Health spokeswoman said that if routine vaccinations had been stopped there would have been a "real risk" of serious and potentially fatal infectious diseases among children. She said all of today's vaccines are produced from non-UK bovine material, and insisted the old UK-based vaccines "appear to have no role to date" in the development of the human version of mad cow disease, new variant Creutzfeldt-Jakob Disease (nvCJD).

So far 53 people have been killed by the disease, another dozen are dying and the victims include three children, aged 13 to 15. [Today's DoH report shows 68 nvCJD victims as of 28 April 00. ]

Public Health Minister Yvette Cooper has told the Commons that some drug companies responded to 1988 reports of BSE by quickly switching to non-UK sources for bovine material for their vaccines. But after a Code of Open Government request for facts, the Daily Express has been told Wellcome continued using UK bovine material in the manufacturing process for four children's vaccines until 1989. Smithidine has said it continued to use UK-sourced material for its Measles, Mumps, Rubella (MMR) vaccine through to February 1990. [These were peak years of the BSE epidemic. A key issue is how long stocks at hand continued to be used. This was apparently until they were all sold or the expiration date reached by 1993. There was apparently never a recall.-- webmaster]

Drugs makers were asked to stop doing that in March 1989, but in an obscure sentence the Health Department suggests it "would have taken months" to eradicate UK-sourced material from the manufacturing process entirely. Wellcome's oral polio doses were also manufactured from UK-sourced bovine material through to 1989, although the last issue and expiry dates are "not known". The Medicines Control Agency told the Department of Health that Smithkline's inactivated polio vaccine was also manufactured from UK-sourced bovine material. However, it was said no such vaccine was sold by the firm in the UK.

Smithkline Beecham said: 'As of February 1990, Smithkline Beecham Biologicals, our vaccine business, ceased sourcing bovine material of UK origin, and replaced it with material from BSE-free countries. Any stock that was remaining, at the request of the UK authorities, continued to be available for sale."

That means unknown quantities of all six routine child immunisations, including Wellcome's oral polio, were kept in doctors' surgeries and were dispensed right through to expiry, towards the end of 1993. But the Health Department admits: "We are unable to provide exact dates on which vaccines manufactured before March 1989 were no longer used. At the time in question, vaccines were not purchased centrally, as they are now."

The Liberal Democrats' Mr Baker said: "The Department of Health was potentially criminally negligent in not requiring the immediate withdrawal or cessation of use of vaccines from potentially contaminated sources. "It is also beyond belief the Department should not even have monitored those who were injected, and is now trying to sweep the whole thing under the carpet"

Opinion (webmaster): This is good step forward to name the compaines and specific vaccines though it is a pity that England doesn't keep records of who received what vaccine the way normal countries do. The previous two mass outbreaks of TSE attributed to vaccines involved louping ill in the 1930's and a 1999 vaccine in Italy, both produced in sheep or goat brain. An Indian physician has also expressed concern about a widely used human rabies vaccines produced in scrapies-endemic sheep brain in India; CJD surveillance there is minimal. No details are provided above on what part of the bovine is used in producing the vaccines, apparently fetal calf serum or bovine serum albumen are used in human cell culture to grow the viruses. The vaccines had been previously discussed in a Phillips Inquiry memo: bovine blood serum, ox heart infusion, casein (milk protein), fetal calf serum, beef muscle infusion, veal, and unspecified sheep use.

Extract from Phillips enquiry, draft factual account 17, 8 Oct 99

14 February 1989 Dr Adams minuting Dr Harris 

1. D have polio, measles, mumps, rubella, rotavirus vaccines.� All use bovine serum from a UK source and bovine commercial product from unknown source.� Some agent comes from the USA and New Zealand.

2. I gave most information (see Appendix 2 [unavailable]).� All their vaccines apart from yellow fever, cholera and typhoid contain bovine material: 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 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. E have measles, mumps, MMR, rubella vaccines.� These are sourced from the USA and the company believes that US material only is used.

4. J 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. K 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. L have diphtheria/tetanus and pertussis on clinical trial [redacted]; These use veal material, some of which has come from the UK and has been made by I (see above).

7. M have influenza vaccines which are made up in egg medium.

8. The Secretary of State has a number of licences.� We understand that the inactivated polio vaccine is no longer being used.� There is a stock of smallpox vaccine.� We have not been able to determine the source material.� (Made in sheep very unlikely to certain bovine ingredients).

9. N have acellular triple vaccine in which I material of UK bovine source has been used.

As far as I can see Company I is the sole supplier of pertussis vaccine which uses bovine casein digest. You should also be aware that DH has made arrangements for meningococal vaccine to be available, on a named patient basis, from D and K.� Both companies use bovine media in production." The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath): No vaccines or other injectable medicines in use in the United Kingdom contain bovine serum derivatives as ingredients in the finished products.

Comment (Kelly): "It seems clear that no bovine derivatives are used in FINISHED products, however they are often used in the culture process. Does this also present a possible risk? Below is the packaging insert for one routine vaccine (inactivated injectable polio vaccine)made by Pasteur Merieux S�rums & Vaccins S. A. Lyon, France (now called Aventis):"

IPOL�, Poliovirus Vaccine Inactivated, produced by Pasteur M�rieux S�rums Vaccins S.A., is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). IPOL� is a highly purified, inactivated poliovirus vaccine produced by microcarrier culture. This culture technique and improvements in purification, concentration and standardization of poliovirus antigen produce a more potent and consistent immunogenic vaccine than the IPV available in the US prior to 1988. The viruses are grown in cultures of V.R. cells, a continuous line of monkey kidney cells, by the microcarrier technique. The cells are grown in Eagle MEM modified medium, supplemented with newborn calf serum tested for adventitious agents prior to use, originated from countries free of bovine spongiform encephalopathy. For viral growth the culture medium is replaced by M-199, without calf serum.

... Neomycin, streptomycin and polymyxin B are used in vaccine production, and although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin and 25 ng polymyxin B per dose may still be present. The residual calf serum protein is less than 1 ppm in the final vaccine. The vaccine is clear and colorless and should be administered intramuscularly or subcutaneously.

The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.

TIP740203/l 0424 CONFIDENTIAL

Mr Cunningham CMP3      From: D O Hagger MBI
Dr Salisbury MED/IMCD3
Mr Burton PD/STB/PG1B B/17/2            Date: 15.02.1989
Mr Dudley PD/AD4

BOVINE SPONGIFORM ENCEPHALOPATHY

1. The purpose of this minute is to alert you to recent developments on
BSE as they affect medicines and to invite representatives to a meeting
in Market Towers on 22 February 1989.

2. The report of the Working Party on Bovine Spongiform
Encephalopathy (BSE) was submitted by the CMO to the Secretary of State
for Health and Minister for Agriculturer on 9 February.

3. The summary at the end of the report records, inter alia: 'we have
drawn the attention of the Licensing Authority to the potential of
transfer of BSE agent in human and veterinary medicinal products. In
paragraph 7 of his submission (Annex A), the CMO notes:

"I am also putting work urgently in hand to satisfy myself that
everything possible has been done to ensure .... that transfer of the
BBE agent in human and veterinary medicinal products does not occur."

4. The Veterinary products Committee meets on 16 February and The
committee on Safety of Medicines on 23 February when each will be
considering a draft of some joint guidelines for manufacturers of
medicinal products which use bovine material as an ingredient or an
intermediate in the manufacturing process (Annex B).....

6. Although a wide range of medicines may be implicated - and the
present proposal is to write to companies for more information - an
"instant" telephone survey of manufacturer of vaccines used for children
has already been undertaken in response to a request from Dr Harris. The
results are in Dr Adams' minute of 14 February (Annex C) - the proviso
in his second paragraph, last sentence should be noted. 
89/02.15/11.1
 
89/02.15/11.2 MF580439/1 0584
SOUTHWOOD REPORT: BSE AND MEDICINAL PRODUCTS

1. I attach a list of questions on BSE and medicines compiled with the
aim of providing question and answer briefing to DH and MAFF Ministers
upon publication of the Southwood Report. I have suggested names of
those who may be able to provide answers.
All recipients are invited to consider which if any important areas have
been missed. Also attached is copy QA briefing being proposed by MAFF. I
understand MAFF have produced General QA briefing on the reports as a
whole.
..

MF580439/1 0585 Question

1. Which medicines are affected? (person to provide reply) Dr. Jefferys

2. Are the risks greater with some medicines than others? Dr. Jefferys

3. Why are medicines affected? Dr. Jefferys

4. Are some affected products available over the counter from pharmacies or shops? Dr. Purves

5. Are only UK products at risk? Dr. Jefferys

6. Are existing stocks safe? Dr. Jefferys

7. Are pre 1980 stocks available? Mr. Burton

8. Are these alternatives to the use of bovine material? Dr. Purves

9. Why can't we throw away suspect stock and import or manufacture safe medicines? Dr. Jefferys

10. Which patients are at risk? Dr. Jefferys

11. Are some patients particularly vulnerable? Dr Jefferys

12. What risks exist to those who have already used these medicines? Dr. Jefferys

13. HOW might patients be affected? Dr. Jefferys

14. Can BSE be transmitted to patients by medicines? Dr. Jefferys

15. How long will it be before risks are quantified? Dr. Jefferys

100 89/02.17/10.2 MF580439/1 0586

16. What research is going on to find out if  medicines can transmit this disease and if any 
patients have been affected? Dr Jefferys

17. Could recent cases of Creuuzfeld Jacob Disease  have been caused by transmission of BSE through medicines? Dr. Jefferys

18. What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes? Dr. Jefferys/Dr. Purves

19. Are the guidelines practical? Dr. Jefferys/Dr. Purves

20. Will the guidelines remove the risk? Dr. Jefferys

21. How will the guidelines be enforced? Dr. Jefferys/Dr. Purves

22. How soon will they come into force? Dr. Jefferys

23. Will the guidelines be published? Mr. Hagger

24. What is being done to reassure patients, parents etc? Mr. Hagger/Dr. Salisbury

25. What advice is being given to doctors, pharmacists etc? Mr. Hagger

26. What advice is the Government giving about its vaccination programme? Dr. Salisbury

27. Is the vaccination programme put at risk because of BSE? Dr. Salisbury

89/02.17/10.3
 
Q. Will government act on this?

A. Yes - thymus is not used in preparation of baby foods but it is
contacting all manufacturers to seek their urgent views on use of
kidneys and liver from ruminants. Will consider any necessary measures
in the light of their response.

VETERINARY MEDICINES

Q. Can medicines spread BSE to other cattle/animals?

A. The report describes any risks as remote.

Q. How can risks be avoided?

A. In liaison with the DOH the Veterinary Products Committee is
examining guidelines for the veterinary pharmaceutical industry
which will be issued shortly.

Q. What will Guidelines say?

A. In essence they call for non-bovine sources to be used if possible,
including synthetic material of biotechnological origin. Where this is
not possible the industry should look for sources which are free of BSE
and which are collected in a manner which avoids risk of contamination
by the BSE agent.

 
89/02.17/10.4 MF580439/1 0588

A. Bovine source material is used in [garbled, cannot read...TSS] and some other medicines.

Q. How many medicines are involved?

A. Computer records show that about 300 of the 3,050 veterinary
medicines licensed in the U.K. are manufactured directly from bovine
source material. However, other medicines may be produced from
bovine sources and a letter is going to all license holders so that a
comprehensive list can be drawn up.
 
89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g

From:   Dr H Pickles Med SEB/B Date: 3 July 1989
 
CATTLE BY-PRODUCTS AND BSE

I was interested to see the list of by-products sent to the HSE. Those
of particular concern included:

*  small intestines: sutures (I thought the source was ovine but you are
checking this)

*  spinal cord: pharmaceuticals

*  thymus: pharmaceuticals

Are you able to give me more information on which UK manufacturers use
these materials? Our proposed ban on bovine offal for human consumption
would not affect these uses, I assume.


   
Id No. 1934/RD/1 89/08.10/6.1 117A

BOVINE SPONGIFORM ENCEPHALAPATHY MEETING
HELD ON 21 AUGUST 1989 AT 2;15 IN ROOM 720
 Miss M Duncan (Chairman)
Mr W Burton
Dr E Hoxey
Mrs J Dhell
Ms K Turner
Dr S Whittle
Mr N Weatherhead
 ...
5. The MCA had sent 2700 questionnaires out, 1,124 had made valid
returns; of these 122 use animal material of some kind and there are 582
products involved.
 ...
6. The MCA/BSE working group will meet on 6th September. Their
aim is to review responses from professional officers in MCA who have
suggested seven categories of importance (with 1 being the most
important} for medical products:

ID 2267/NRE/1 89/08.21/10.1 

1. Products with Bovine brain/lymph tissue administered by injection.

2. Products with bovine tissue other than brain/lymph administered by
inection.

3. Tissue implants/open wound dressing/surgical materials/dental and
ophthlamic products with bovine ingredients.

4. Products with bovine ingredients administered topically.

5. Products with bovine ingredients administered orally.

6. Products with other animal/fish/insect/bird ingredients administered
by injection/topically/oral routes.

7. Products with ingredients derived from animal material by chemical
processing (eg stearic acid, gelatine, lanolin ext.

The BSE working group will decide which of these are important, and
should be examined more closely, and which categories can be eliminated.

The responses by the companies were presented by Ms Turner and were
categorised by MCA standards, the products that were discussed were all
low volume usage products eg sutures, heart valves.

8. As the responses included some materials of human origin it
was decided that more information should be sought about CJD. There had
been 2 recent deaths reported associated with human growth hormone.
These were being investigated.

9. Re-editing of the Paper on "Incubation of Scrapie-like Agents"

It was suggested that the document could be sent out to companies with
the non-standard sterilization Document. The document could have severe
implications on the companies whose products have a high risk factor as
decided by the MCA working group....

How To Legally Avoid Unwanted Immunizations Of All Kinds

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