Rabies Vaccine Supply Situation

Posted: August 29, 2008

Current Situation

• As of August 29, 2008, Sanofi Pasteur in coordination with the Centers for Disease Control and Prevention (CDC) will resume shipping IMOVAX® Rabies, Rabies Vaccine for post-exposure prophylaxis only. Novartis Vaccines will no longer be shipping supplies of RabAvert®. ( Novartis – letter to Customers [PDF – 524 KB] )
• To obtain IMOVAX rabies vaccine you must first contact your Rabies State Health Official so a risk-assessment can be conducted for the suspected exposure. If your Rabies State Health Official determines that post-exposure prophylaxis is required they will provide you with a pass code 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 pass code provided by your Rabies State Health Official. Please contact Sanofi Pasteur at 1-800-VACCINE to obtain the required form. Please click here for a list of the Rabies State Health Officials.Note: The Pass Code changes frequently so you will need to contact your Rabies State Health Official to conduct a risk-assessment after each new suspected exposure.
• Vaccine availability for pre-exposure vaccination continues to be limited, and will be distributed on approval from state and federal public health authorities for those first responders with a critical need and in consideration of available supplies. These measures will allow responsible management of currently limited supplies of this vaccine for those individuals at highest risk of exposure.
• Both Novartis Vaccines and Sanofi Pasteur remain in close contact with public health authorities to ensure that guidelines for appropriate usage of vaccine for PEP is communicated to medical providers.
• Discussions among federal, state, and local public health personnel are ongoing to review additional strategies to manage this situation.

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.).

Previous Updated on this Situation

• 8/11/2008
• 7/31/2008
• 7/15/2008
• 6/16/2008
• 5/20/2008