***********************************************
A ProMED-mail post
ProMED-mail is a program of the
International Society for Infectious Diseases
Date: Wed 11 Mar 2009
From: Robert Dedmon
This issue of rabies in Bali and travelers is of concern to those of
us in the USA with patients/clients planning travel to Bali in the
near future. At present, there is no vaccine available for
pre-exposure use in the USA (personal communication C. Rupprecht, CDC
USA yesterday, 10 Mar 2009). What is the situation in other countries?
R.E. Dedmon, MD
Clinical Professor
Medical College of Wisconsin
Milwaukee
333 Park Drive
Neenah WI-94956-2875
USA
[The most recent statement regarding the rabies vaccine supply
situation on the US CDC website dated 9 Feb 2009
gives the following information:
* The rabies vaccine supply situation has not altered since the 8
Oct 2008 update. Novartis continues to be able to deliver RabAvert
vaccine for post-exposure prophylaxis without supply restrictions.
Questions can be directed to Novartis customer service at 1-800-244-7668.
* Sanofi Pasteur continues to have IMOVAX vaccine available for
post-exposure prophylaxis following risk assessment from a state or
local health department official.
* To obtain IMOVAX rabies vaccine, you must 1st contact your Rabies
State/Local Health Official so that a risk-assessment can be
conducted for the suspected exposure. If your Rabies State Health
Official determines that rabies post-exposure prophylaxis is
indicated, they will provide you with a passcode to place on the
Sanofi Pasteur Rabies Post-Exposure Form. The form must be filled out
in its entirety, including the required physician's signature and
passcode provided by your Rabies State Health Official. Please
contact Sanofi Pasteur at 1-800-VACCINE to obtain the required form.
* Rabies immune globulin remains available with no changes in
historical supply.
* Rabies Vaccine for pre-exposure vaccination continues to be
limited to high risk occupations and First Responders.
Why is there an interruption in supply?
* Starting in June 2007, Sanofi Pasteur began renovating its IMOVAX
Rabies vaccine production facility in France to maintain compliance
with the most current requirements from FDA and the French regulatory
body. Prior to these renovations, Sanofi Pasteur established an
inventory based on historical levels of sales and projected market
demand. The facility is scheduled to be approved and operational by
mid-to-late 2009. Until the facility is operational, Sanofi Pasteur
has a finite amount of IMOVAX Rabies vaccine.
* After the renovations began, Novartis, the other supplier of
rabies vaccine for the United States, was unable to meet projected
rabies vaccine supplies.
* Since early 2008, Novartis has been supplying its rabies vaccine,
RabAvert, for post-exposure use only. Consequently, Sanofi Pasteur
has been supplying nearly all of the market for rabies vaccine. The
increase in demand for IMOVAX is outpacing the company's historical
levels of supply.
How does this affect current rabies vaccination recommendations?
* Persons at increased risk for rabies exposure should take
appropriate precautions to avoid rabies exposure.
* Vaccine is available for PEP, and providers should consult with
their local or state public health department to ensure appropriate use of PEP.
* General rabies awareness and prevention messages should be
emphasized to avoid exposure (e.g., avoid wildlife contact, vaccinate
pets/livestock, capture/observe/test exposing animal, etc.).
Dr Dedmon's response to the ProMED-mail RFI is highly relevant, and
in its turn generates a follow-on RFI. Other nationals contemplating
travel to Bali should be aware of their own situation. - Mod.CP]
No comments:
Post a Comment