Plague vaccine

Correspondence with Manufacturers, UK subsidiary and US Customer (DoD)

Initially I wrote to Greer Labs at the following address:

Greer Laboratories, Inc.

P O Box 800


North Carolina



Tel: 704/754-5327

My first letter was sent on 21 Mar 94, the text is as follows:

Dear Sir/Madam,

I am writing to you because I believe that your corporation is or has been involved in producing the plague vaccine, known as "Cutter".

I am trying to find some information about this vaccination, as I was given it during Operation Desert Storm back in 1991. If you have a product data sheet about this vaccine, I would appreciate it if you could send me a copy, I am particularly interested in the short and long term side effects and any contraindications there may be.

The reply arrived dated 14 April 1994, signed by Linda Housand on behalf of Mr Clay Sisk, it reads as follows (the data sheet was also enclosed):

As requested, we are pleased to enclose the Directions for use product enclosure for Plague Vaccine,USP.

According to our Regulatory Affairs Manager, Mr Clay Sisk, one would expect "short term tenderness and soreness, and possibly others as mentioned in the product insert. None lasting more than 2 days or so. No long term effects are known or expected".

Please do not hesitate to contact Mr Sisk if you have questions or require further information.

My next letter was sent to Mr Sisk on 24 April and reads as follows:

I noticed that in the data sheet it states that Cutter should not be given with Cholera or Typhoid, I would like to pick up on this point. When I got my Cutter shot, it was at exactly the same time as I got the second anthrax and whooping cough shots and I was also taking pyridostigmine bromide. The effect of all these shots at the same time was to put me on cloud nine for about 24 hours, in fact I was walking around and I could not feel my feet touching the floor, other people got really sick and bad stomach cramps.

I am not saying that the Cutter shot caused this, rather the combination of shots did. Could you let me know if the Cutter shot should have been given at the same time as the other shots, again this is a question that no one seems able to or even wants to answer over here.

The reply arrived dated 16 May 1994, again signed by Linda Housand, it reads as follows:

In response to your letter of 24 April 1994, our Regulatory Affairs Manager, Clay Sisk, advises the following:

"Pyrodistigmine Bromide, in high doses, might cause stomach cramps".

"The symptoms you have related could have been caused by the combination of shots received".

"Anthrax pertussis (whooping cough) and Yersinia pestis (plague) are all bacterial vaccines, each of which cause similar side effects and if given together, can cause additive reactions. If given together, one should expect a high rate of systemic reactions, such as malaise, muscle soreness, headache and possible fever. Giving the vaccines in different arms or muscles may be helpful in minimizing local reactions at the injection site, but the systemic reactions will likely be the same. It is a medical decision as to whether the expected higher rate of reactions are acceptable to achieve earlier vaccination protection than could be gained by staggering the vaccinations further apart."

Please do not hesitate to contact us if you require further information.

My next letter was sent to Mr Sisk, dated 3 July 1994. It reads as follows:

First of thankyou for your letter dated 16 May 94, it was very useful. However, I do have one more question to ask: The batch number of the plague vaccine that I was given is 10H03A, could you please let me know on what date this batch was exported to the UK and, has it ever been exported to the UK prior to the Gulf War and finally, does this vaccine bear any relationship to the Botulinum Toxoid that was given to the American Troops?

The reply arrived dated 14 July 1994, again signed by Linda Housand, it reads as follows:

In response to your letter of 3 July, our Regulatory Affairs Manager, Mr Clay Sisk, advises the following:

The Plague vaccine is no relation to botulinum toxoid.

The lot number indicates that this vaccine was made in 1991 by Miles Inc. We have no knowledge regarding their shipments to the United Kingdom.

We regret that we cannot provide this information. Please advise if we may be of further assistance.

Next I wrote to Miles Inc at the following address:

Miles Pharmaceutical Division

Biological Products

Miles Inc

4th & Parker Streets

P O Box 1986


CA 94701


Tel: 510-420-5120

It was dated 6 August 1994, the text reads as follows:

Dear Sir/Madam,

I am writing in the hope that you may be able to help me in my investigation into my illness that I am suffering with since my participation in Op Desert Storm.

I have been in touch with Mr Clay Sisk of Greer Labs in the USA, he has indicated to me that the batch of Plague vaccine that I was given was manufactured by your company in 1991.

I would like to ask the following questions of you please.

a. The batch No that I had was 10H03A, could you please tell me on what date this batch was manufactured?

b. Was it dispatched straight to Saudi Arabia or was it first sent to the UK?

c. Has this vaccine ever been exported to the UK prior to the Gulf War and does it have a UK licence No? (I have not been able to find an answer to this anywhere).

d. In your opinion, and bearing in mind the information given on the product information sheet, would it have been advisable to give the plague vaccine within seconds of the anthrax and whooping cough vaccines whilst taking pyridostigmine bromide as well?

Please rest assured that I am not compiling a legal case against yourselves nor am I blaming your product for what has happened to me, however, I am worried about the effect that the above mentioned "cocktail" has had on my immune and nervous system. I believe that the MoD here in the UK did not follow any ethical guidelines when administering this cocktail to us and furthermore, I cannot find any information relating to clinical testing of this cocktail, when administered all at the same time.

In addition to the above, are you aware of any organisations that may be able to offer me information regarding the anthrax vaccine?

I look forward to your reply and would like to thank you in advance for your co operation.

The reply arrived dated 11 August 1994, signed by Ralph H Rousell, Director Safety Assurance, Biological Products.

Your letter of August 6, 1994, concerning the plague vaccine has been forwarded to me for reply.

1. During the period of your inquiry plague vaccine was manufactured in the USA by Cutter Laboratories, Miles Inc.

2. Batch No 10H03A was manufactured on June 1, 1990, and had an expiry date of March 1,1992.

3. This entire batch was shipped to one of the USA military supply depots in the USA. We are not informed of the further distribution.

4. Plague vaccine was licensed in the USA and Canada (US license No. 8: Canadian license No. 28). A license was never applied for in the UK but it was available for usage in the UK on a named patient basis.

5. The recommendations for use of the vaccine are given in the package insert.

6. The package insert recommends against the use of the vaccine on the same occasion as typhoid and cholera vaccines to avoid the possibility of accentuated side effects. We do not have experience of and hence cannot supply any information on the concomitant usage of anthrax and whooping cough vaccines together with pyridostigmine bromide.

7. We do not have any information on the manufacturers of anthrax vaccine. Your best source of information on this aspect is the British Medical Authority or possibly one of the British vaccine manufacturers. The Association of the British Pharmaceutical Industry could probably suggest some manufacturers names.

My next letter was sent to Mr Rousell on 24 August 1994, it reads as follows:

Dear Mr Rousell,

first of may I thank you for your letter dated 11 August 94, it was most informative.

I note from your reply that the plague vaccine in question is not licensed in the UK, nor has the UK ever applied for a license but you do point out that the vaccine is available on a named patient basis. This leads me to an additional question:

Did the UK Ministry of Defence or the UK Government make a specific request to Miles Inc or Greer Labs during 1990 or 1991 for a supply of this vaccine for use in the Persian Gulf?

I also note that you state that the entire batch (10H03A) was shipped to a US military depot, if the UK had requested this vaccine from yourselves would it not be feasible to have expected it to come to the UK first?

Once again may I thank for your help in this matter, it has proved to be most informative.

The reply arrived dated 21 September 1994, unsigned and stating that this letter was "written but not read by Ralph H Rousell, MD.,FFPM., Director Safety Assurance, Biological Products.

In reply to your questions:

1. In 1990-1991 we did supply small quantities of plague vaccine to our Bayer UK affiliate in the United Kingdom. Lot 10H03A was not sent to them. The supplies were at their request for distribution on a named patient basis. Such information is however confidential and cannot be released without the approval of the customer.

2. We are not informed of requests to, or distribution by Greer Laboratories. You should contact them for information. They took over manufacture in 1992.

3. I cannot speculate as to what might have happened to plague vaccine lot 10H03A if the United Kingdom had requested vaccine. The facts are (as stated in my letter of August 11, 1994) that the entire batch was delivered to a USA military supply depot, in accordance with a supply/purchase order received by us.

4. Each order is handled individually as it is received.

5. As I suggested in my previous letter, you should contact the appropriate authority in the United Kingdom to ascertain the mechanism through which the vaccine/s were used in the UK and the source of the vaccine which you received.

Next I wrote to Bayer UK, the text of the letter is as follows:

Dated: 16 February 1995

Medical Information Officer

Bayer PLC

Pharmaceutical Business Group

Bayer House

Strawberry Hill



Dear Sir/Madam,

I am writing to you following correspondence that I have had with one of your affiliate companies, namely, Miles Pharmaceutical in the USA.

I have been writing to a Mr Rousell at Miles regarding Plague vaccine USP. In his letter dated 21 September 1994 (copied to R. Lutes and J Pennington of your company), Mr Rousell informed me that a quantity of this vaccine was supplied to your company.

I do not want to ask specifically who this vaccine was for, however, I would like to know if, at any time, has CBDE Porton Down or the National Institute of Biological Standards and Control been supplied with any of this vaccine, and if so, on what date?

My reason for asking this question is that I was given an injection of this vaccine along with others whilst on active service during Operation Granby in the Gulf. Hence, I am trying to establish whether or not this vaccine was tested in the UK by either of the above agencies, prior to it being administered to the troops.

Any help you can offer would be very much appreciated. I look forward to your reply.

This is a transcript of the reply that I received from Bayer UK today, dated 27 February 1995, it reads as follows:

Your letter of 16th February regarding Miles' plague vaccine has been passed to me for a response - thankyou for writing. You indicated that Dr Roussel had copied Dr Pennington and Dr Lutes of the Bayer Company, but in fact they are his colleagues in Berkley, California. I accordingly wrote to Dr Pennington on the 22nd February and received a faxed reply from Dr Roussel. He has sent me a copy of his earlier letter to you, dated 11th August, which suggests that the Medical Director of Bayer UK was copied with the original, but I never received same.

Bayer used to hold small quantities of plague vaccine, largely for named patient use at the request of British Airways, and batch samples have been sent to CBDE Porton Down at intervals. I have made a careful search of our files and confirm that batch 10H03A was never imported at Bayer's request, or with our knowledge, into the UK.

Letter ends

Next I wrote to Miles Inc again, the text of this letter is as follows:

Dated: 6 March 1995

Dear Mr Rousell,

I apologise for writing to you again, however, as a result of recent communications with Dr Macdonald of Bayer UK, I feel that I have to investigate this a little further.

As I have stated previously, I have no axe to grind about the Plague Vaccine, I am merely now attempting to find out how the UK troops came to receive it when it doesn't appear to have been obtained on a named patient basis.

In your letter to me dated 11 August 1994 (ref DK_49.470), you stated that the whole batch of vaccine (10H03A) was shipped to a US Military supply depot in the USA. If possible would you be able to let me know which supply depot this was so that I can write to them to ask how the batch was requested for use on UK troops.

When this question is asked over here, we just hit a brick wall.

Finally, may I thank you for all your help in the past, I look forward to your reply.

On May 2nd 1995, I recieved the following from Mr Rousell. I apolgise here as I must have written to him asking about the discontinuance of plague vaccine, unfortunately I cant find this letter

Your previous letter was referred to Mr R Modersbach in our legal offices as it did not directly concern drug safety issues nor clinical research. I understand Mr Modersbach did send a reply to you.

I am also referring your present letter to him for reply

I am not aware that the manufacturining of plague vaccine had been discontinued. In mid - 1992 we turned over production and subsequently the manufacture of plague vaccine to:

Grier Labs

PO Box 800

639 Nuway Circle NE

Lenoir, NC 28645

Customer service phone: 1-800-438-0088 or 1-704-754-5320

As far as I am aware they continue to manufacture and distribute the product.

Next I recieved a letter, two in fact from Mr Modersbach in the legal offices. One is dated 29 June 1995, the other 13 April 1995, the latter appears last of the two below.

I was distressed to learn from Dr Rousell that you did not recieve my earlier reply to you dated April 13, 1995. I cannot account for this and am very sorry for any resulting inconvenience.

Attached is a copy of my earlier letter.

Again, my best wishes for success in your endevours.

This is the earlier letter dated 13 April 1995:

Your letter of 6 March 1995 to Dr Rousell was forwarded to me since your enquiry related to our manufacture and supply of product under government contract, and not to medical aspects of a Bayer (formerly Miles Inc.) product.

I admire the efforts you are making for what must be a most difficult task. To respond to your immediate question, our sole customer for the production of plague vaccine prior to our discontinuation of that product in 1992 was the US Department of Defense. Our company would have no information, data or concept whatsoever as to the disposition of the product upon shipment of the product to the Department of Defense, which basically served as the procurement arm for the US government including the military.

The relevant Department of Defense location for plague vaccine was:

Defense Personnel Support Center (DPSC)

2800 South 20th Street

Philadelphia PA 19101-8419


Telephone: (215) 737-2000

I sincerely hope this will be a fruitful lead for you, but I expect the tenacity you have already demonstrated will continue to be needed.

As I am sure you've read and seen in the UK, there was a recent US research suggestion potentially linking the Gulf War Syndrome with a nerve gas/insecticide protectant. I expect you're following up on that. In all events, I hope you and others afflicted with the condition will find the cause as well as the appropriate relief you deserve.

OK, so the trail has led us into the DOD, so please follow this link to the letters leading up to the appeal against the FOIA, the appeal itself and the ensuing mail!

last updated by dave austin on thursday, 26 december, 1996 at 6:06 pm.

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