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Restrictions on Rabies Vaccine Due to Supply Issue


 

ACIP's recommendations on preventing human rabies are available at www.cdc.gov/mmwr/preview/mmwrhtml/rr5703a1.htmwww.cdc.gov/rabies

Health care providers who prescribe postexposure rabies prophylaxis will be required to confer with public health officials and obtain a confirmation code from their respective state health departments before they can order doses of the vaccine, because of limited supplies of the only rabies vaccine that is available, the Centers for Disease Control and Prevention announced.

An update on rabies vaccine availability posted on the CDC's Web site states that the CDC had been notified by Novartis AG, the manufacturer of the human rabies vaccine RabAvert, that the availability of the vaccine in the “near term” could be affected because the supply was being used “at a higher rate than expected.”

At press time, Sanofi Pasteur, the other supplier of rabies vaccine in the United States, said that it has built a supply of its rabies vaccine, Imovax, “that will enable us to meet our historic demand for the vaccine. However because the [rabies vaccine production] facility is currently shut down for renovation, we are unable to produce additional vaccine to meet increased demand,” according to a company spokesperson. “Renovation [of the facility] is on schedule and we expect to be approved and on schedule to reopen by the fourth quarter of 2009.”

“Judicious and appropriate use of rabies vaccines is crucial to avert a situation in which persons exposed to rabies are put at increased risk due to depleted vaccine supplies,” the CDC statement said.

Both companies are requiring that providers obtain the confirmation code to ensure that thorough risk assessments are done before ordering vaccine for postexposure prophylaxis, according to the CDC.

“These codes should only be released by a state/local health authority that has reviewed the known facts of a given exposure and determined they indicate a sufficient level of exposure risk” as described in the CDC's Advisory Committee on Immunization Practices (ACIP) recommendations on preventing human rabies, which were updated earlier this year.

The CDC statement says that the new requirements will remain in place until vaccine supplies are adequate.

In May, the CDC announced that vaccine would temporarily be unavailable for preexposure prophylaxis. The current statement says that until supplies are adequate, distribution of rabies vaccine for preexposure prophylaxis will require approval from state and federal public health authorities, with priority given to workers in rabies laboratories, animal control officers, veterinary staff, wildlife workers, and other people at risk for occupational rabies exposure, according to the CDC.

The CDC statement also points out that while people with a possible exposure to rabies need to be evaluated as soon as possible and that postexposure prophylaxis (PEP) is an “urgent medical issue,” it is not considered an emergency, and PEP can be delayed until after the animal has had rabies testing “or clinical observation is completed,” an approach that “not only limits administration of PEP to persons with confirmed rabies exposure, but it is also cost saving and conserves limited resources.”

A national working group has been formed to monitor the supply situation and to provide updated recommendations “as the situation evolves,” the CDC said.

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