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UK Medicines Control Agency

Author: Not Specified
Publication: Not Specified
Document Dated: Not Specified
Date Posted: January 15, 1997

The UK Medicines Control Agency

Correspondence with the MCA on the subject of Anthrax and "named patient basis"

9 September, 1996

Subject: Anthrax vaccine Batch Numbers 01/90 & 337/E

Dear Sir/Madam,

I have been researching the above batches of anthrax vaccine for some time now, however, it somewhat difficult to obtain information!

As you can see from the letter head I am a Gulf Veteran and was injected with this vaccine among others whilst in the Gulf . As far as the anthrax goes we were given it in combination with pertussis, which at the time we were led to believe was acting as an adjuvant for the anthrax. I questioned CDC in America about this particular combination and they had never heard of, nor would ever consider using it. I also questioned CAMR at Porton Down about this, they would make no comment at all, not even about the above batch numbers.

Could I ask you if you recognise either of the above two batch numbers, if you do who holds the licence for making them and how might they be contacted?

Also, have you ever heard of the anthrax/pertussis combination being used and if so, were and by whom?

Finally, plague vaccine, could you explain thoroughly the mechanism of "named patient basis" or direct me to a document that does. I have ascertained from the manufacturers of this vaccine in the US that is only licensed in the US and Canada, but is available for use abroad ona named patient basis, I have also ascertained that this was never requested by the UK authorities from the manufacturers or the sole customer, the US DoD.

Many thanks for your time and help in this matter and I look forward to your reply.

The reply arrived dated: 15 October 1996

Thankyou for your letter dated 9 September 1996. I have consulted several experts within both the Medicines Control Agency and the Department of Health who have provided me with the following information.

According to our licensing records the licence for Anthrax vaccine is held be the Secretary of state for Health at the Department of Health. I understand that the information leaflet enclosed with the vaccines makes no mention of the Anthrax/Pertussis combination being either indicated or contraindicated.

The basis of named patient supply is that a registered doctor or dentist can prescribe any medicinal product they consider most suitable for the needs of their patient. Where this product is unlicensed the prescriber takes personal responsibilty for the patients safety

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