Temporary Unavailability of Rabies Pre-exposure Vaccination

Posted: May 20, 2008

Current Situation

• Effective May 19th, 2008, Sanofi Pasteur maker of IMOVAX Rabies (Rabies Vaccine) will temporarily only provide vaccine for post-exposure prophylaxis.
• Sanofi Pasteur will continue to supply their vaccine to health care providers, who in consultation with public health, are treating patients who have had documented rabies exposures.
• These measures will allow responsible management of currently limited supplies of this vaccine.
• A letter from the manufacturer explaining this change will be released to clinicians on Monday, May 19 th, 2008.
• Novartis, the other supplier of rabies vaccine in the US, currently has limited amounts of rabies vaccine, RabAvert, which is available for postexposure prophylaxis use only. It is expected that additional RabAvert will be available to the market by approximately July 2008. It is hoped that the demand for pre-exposure vaccine supplies will be met at this time.
• Discussions among federal, state, and local public health personnel are ongoing to review additional strategies to handle pre exposure vaccination needs (Pre EP)

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?

• Pre-EP should be delayed until vaccine is available. It is expected that additional vaccine will be available again approximately in July 2008.
• 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 local/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.)