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Rabies Vaccine Supply Situation

Posted: July 31, 2008

syringe and vials of medicine

Current Situation

  • Novartis Vaccines has announced that it is no longer necessary to procure a confirmation code from your Rabies State Health Officials to purchase RabAvert. Orders can now be placed directly with Novartis Vaccines for post-exposure prophylaxis.
  • Novartis is continuing shipments for post-exposure prophylaxis use through October 2008. 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.

Why is there an interruption in supply?

  • This report provides an update to information posted previously on July 15th, 2008.
  • 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 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 Updates on this Situation

 
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