VERORAB (rabies vaccine)

Verorab is completely interchangeable with the licensed rabies vaccines which have usually been available in the UK. It is not licensed here but it is widely used and has licences in Europe and other parts of the world.

Just as with any unlicensed vaccine you need to inform the patient regarding the implications of this regarding any adverse event but try to be reassuring regarding the fact that it is not unlicensed due to any known safety issues but simply because it had to be imported to cover the shortage here too quickly for a license application to go through and that such licenses cost companies far too much to apply for in temporary situations. I have heard a rumour that a license might be pending though. You also need to use a PSD or get it prescribed before you administer it.

Below is the Sanofi Q&A leaflet that they produced when first distributing verorab back in October

VERORAB (Purified Vero Rabies Vaccine (PVRV)) Question & Answer
document
Q. Why will Rabies Vaccine BP (HDCV) no longer be available?
A. In July 2007 Sanofi Pasteur began upgrading its vaccine production facility in France.
Periodical upgrading of production facilities is normal business for vaccine manufacturers.
In preparation for the upgrade, SPMSD anticipated the production gap in the market by
building up a stockpile of Rabies Vaccine BP (HDCV), based on historical levels of sales and
our existing markets. However during the second half of 2007, there has been an increased
demand on our stockpile of rabies vaccine which has led to this shortage.
Following discussions between the vaccine manufacturers and the Department of Health, in
the interest of public health and with the approval of the MHRA, Sanofi Pasteur MSD will
temporarily supply VERORAB (PVRV) to the UK as a contingency replacement.
Q. Is Rabies Vaccine BP (HDVC) being discontinued?
A. No. Sanofi Pasteur MSD has temporarily paused production of Rabies Vaccine BP
(HDCV) during the upgrade to production facilities in France.
Q. When will the upgrading of the production facility in France be completed?
A. The upgraded production facility is scheduled to be approved and operational by mid-tolate
2009.
Q. If VERORAB (PVRV) is an unlicensed vaccine, why is it being supplied in
the UK?
A. In some circumstances, for example in the interest of public health, it may be necessary for
the Department of Health to recommend the use of vaccines that do not have a licence in the
UK. VERORAB is currently being supplied on an unlicensed basis in the UK due to a
shortage of licensed rabies vaccine.
Ref: Department of Health Immunisation against infectious diseases, 2006. Chapter 8
Q. As VERORAB (PVRV) is unlicensed in the UK, can it be administered under
a PGD?
A. No. An unlicensed product cannot be administered using a PGD (Patient Group Direction),
a Patient Specific Direction (PSD) is required.
Ref: Department of Health Immunisation against infectious diseases, 2006. Chapter 5
Q What is a Patient Specific Direction (PSD)?
A. A PSD is a written instruction from an independent prescriber (doctor, dentist or
independent nurse prescriber) to another healthcare professional, to supply and/or administer
a medicine directly to a named patient, or to several named patients. For convenience, where
several individuals require vaccination, a list of these named individuals can be printed and
authorisation signed by the prescriber.
Ref: Department of Health. Immunisation against infectious diseases, 2006. Chapter 5
Q. Where can I get a PSD for VERORAB (PVRV)?
A. As a PSD is individually tailored to the needs of a single patient there is no official
prescribing instruction or format. A full risk
assessment should be carried out by the prescriber (e.g. doctor or independent nurse
prescriber) to establish the individual needs of the patient prior to giving a written instruction
(PSD) for the administration of the vaccine to a named patient.
Ref: Department of Health. Immunisation against infectious diseases, 2006. Chapter 5 p36/37
Q Has VERORAB (PVRV) been used in the UK before?
A Yes, the vaccine was previously used in 1998 on an unlicensed basis in the UK.
Q. Can VERORAB (PVRV) be used in the same way as other rabies vaccines in
the UK?
A. Yes, VERORAB (PVRV) is indicated for both pre-exposure vaccination and postexposure
prophylaxis in all age groups.
The Department of Health recommend a course of three doses of rabies vaccine given on
days 0, 7, and 28 for primary pre-exposure immunisation.1,2
Ref:
1. Department of Health Immunisation against infectious diseases, 2006. Rabies Chapter
2. NaTHNaC http://www.nathnac.org/pro/clinical_updates/rabiesvaccines_04Aug08.htm
Q. What is the upper and lower age limit for the use of VERORAB (PVRV)?
A. There is no upper or lower age limit.
Q. What are the recommended storage conditions for VERORAB (PVRV)?
A. Store in a refrigerator between 2OC 8OC. Do not freeze.
Once constituted, the product must be used immediately.
Ref: VERORAB (PVRV) Patient Information Leaflet (PIL) Section 5
Q. What are the pack dimensions for VERORAB(PVRV)?
A. 48.5mm x 22.5mm x 141.5mm

I have been using verorab for some time and have not incurred any problems. The same rabies vaccine shortages are happening globally and in America they cannot even access verorab at the moment and are in even more trouble than us. Some American Practitioners are already having to resort to hte old controversial route of using i/d administrations to share one dose of i/m vaccine between more people!

I would not hesitate to recommending verorab for you traveller who you rightly deem is at risk although it also depends on how long he will be exposed to thiws risk and how soon he departs [ie. Have you time to adminster the vaccine?] ..................

Please be informed that the above is the opinion of the author and is in no way meant to be taken as instruction.

karen


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