June 15, 2008

 
take notice

 Human rabies vaccines temporarily limited - June 15, 2008


posted June 1, 2008

 

Effective May 19, IMOVAX Rabies, a rabies vaccine manufactured by Sanofi Pasteur, will be temporarily unavailable for pre-exposure prophylaxis in the United States.

Sanofi Pasteur will continue to supply their vaccine to health care providers, who in consultation with public health officials will treat patients who have had documented rabies exposures. This measure will allow responsible management of the limited supplies.

Novartis, another supplier of rabies vaccines in the United States, has limited amounts of the rabies vaccine RabAvert, which is available only for postexposure prophylaxis. Officials anticipate there will be enough vaccine lots approved and distributed by Novartis by July 2008 that vaccines will be available for pre- and postexposure uses.

Discussions among federal, state, and local public health personnel are ongoing to review additional strategies to handle pre-exposure vaccination needs.

Individuals with an increased risk for rabies exposure are encouraged to take appropriate precautions. Visit the Centers for Disease Control and Prevention's Web site at www.cdc.gov/rabies/exposure for more information.

Individuals who are concerned about having a low titer should request a rapid fluorescent focus inhibition test, which is used as an indicator of an adequate adaptive immune response. Those who are in the middle of a pre-exposure prophylaxis regimen should have their health care professional complete the regimen using already purchased vaccine supplies. If this is not possible, the pre-exposure prophylaxis should be discontinued and the person considered as nonvaccinated. If needed, the course should be restarted once an adequate vaccine supply for pre-exposure prophylaxis is available.

Several factors contributed to the vaccine shortage. Starting in June 2007, Sanofi Pasteur began renovating its IMOVAX Rabies vaccine production facility in France to maintain compliance with Food and Drug Administration requirements and the French regulatory body. Prior to these renovations, the company established inventory on the basis of historical levels of sales and projected market demand. The facility is scheduled to be approved and operational by late 2009.

After renovations began at Sanofi Pasteur, Novartis was unable to meet projected needs for rabies vaccine supplies.

Since early 2008, Novartis has supplied RabAvert for postexposure use only. Consequently, Sanofi Pasteur has been supplying nearly all pre-exposure rabies vaccines. The increase in demand for IMOVAX is outpacing the company's historical levels of supply.

For more information on the vaccine shortage, visit the CDC Web site at www.cdc.gov/rabies/news/2008-05-20_PreEVax.html.