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Interim Centers for Disease Control and Prevention (CDC) guidance for use of smallpox vaccine, cidofovir, and vaccinia immune globulin (VIG) for prevention and treatment in the setting of an outbreak monkeypox infections

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      Wednesday, June 11, 2003, 19:00 EDT (7:00 PM EDT)

      CDCHAN-00146-03-06-11-ALT–N The following guidance on the use of smallpox vaccine, cidofovir, and vaccinia immune globulin (VIG) is provided by CDC for purposes of monkeypox outbreak control. In most instances, only limited data are available on which to directly base recommendations and thus the guidance is primarily based on expert opinion. This interim CDC guidance was developed using the best available information about the benefits and risks of smallpox vaccination, VIG, and cidofovir for prevention and/or management of smallpox, monkeypox and complications of vaccinia infection. Smallpox vaccine for controlling outbreaks of monkeypox would be available under an investigational new drug (IND) protocol sponsored by CDC.

      Limited information is available on efficacy of smallpox vaccination for prevention of monkeypox. The data suggest that preexposure smallpox vaccination is highly effective (>85%) in protecting persons exposed to monkeypox from disease (1-5). No information is available on the efficacy of post-exposure vaccination. Data which suggest smallpox vaccination following exposure to smallpox is effective in preventing or ameliorating disease suggest that post-exposure smallpox vaccination should have similar impact against monkeypox. Data from investigations in Africa in the 1980's suggested that in household settings, secondary transmission occurred to about 8 - 15% of contacts. Among infected human cases, reported mortality rates have ranged from 1 - 33%, but were most frequently reported to be between 4-10% (1-8).

      Because of the seriousness of this disease, CDC has developed interim guidance which attempts to balance the risks of smallpox vaccination against the risks posed by exposure to monkeypox infection. This interim guidance will be re-evaluated as more information becomes available.

      It is important that vaccinators actively follow vaccinees, evaluate vaccination sites for major reactions, and re-vaccinate when takes are not identified, as currently occurs in the pre-event smallpox vaccination program. State and local health departments should provide information on how vaccinees should seek consultation on evaluation of vaccination sites for major reactions or for potential complications of vaccination.

      Rash illnesses suspected to be monkeypox should be confirmed by laboratory evaluation which, in addition to determining the presence of monkeypox, should have the capability to detect varicella, vaccinia and other relevant viruses. Confirming suspected cases of monkeypox is particularly important before recommending vaccination in instances where there is close or intimate contact between persons with rash illness and persons with contraindications to smallpox vaccination in the pre-event smallpox vaccination setting such as pregnant women, persons with eczema, and similar persons at higher risk for life threatening complications of vaccinia exposure. As general guidance, for purposes of smallpox exposure, close contact has been defined as >3 hours of direct exposure within 6 feet and this is reasonable guidance for monkeypox exposure as well. Intimate contact refers to contact resulting in exposure to body fluids or lesions of affected persons. However, judgment must be applied to determine the significance of contact in individual exposures situations. If there are difficulties in obtaining rapid laboratory confirmation in these situations, the state health department should be urgently consulted.

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