Rabies Vaccine Supply Situation

Posted: August 11, 2008

Current Situation

Due to a significant increase in demand and a minor production delay with IMOVAX Rabies vaccine, Sanofi Pasteur currently does not have IMOVAX Rabies vaccine available.
Sanofi Pasteur expects to have IMOVAX Rabies vaccine doses available again in the late-September to early-October timeframe. In the meantime, please contact Novartis at 1-800-244-7668 to obtain Rabies vaccine doses for patients who have been exposed to rabies.
Novartis is continuing shipments for post-exposure prophylaxis use through October 2008 (A confirmation code from state or local health departments is not currently required). Additional doses of vaccine are anticipated to be available at that time and current supply concerns are expected to be alleviated with receipt of this additional material.
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 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.

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.

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.)