Background: At the June 24, 2009 Advisory Committee on Immunization Practices (ACIP) meeting, ACIP voted to reduce the number of vaccine doses in the human rabies PEP series from 5 to 4 doses. The new recommendations for PEP reduce the number of human rabies vaccine doses to 4 given on days 0, 3, 7, and 14 by eliminating the previously recommended 5th dose on day 28. Human rabies immune globulin (HRIG) continues to be recommended (20 IU/Kg) on day 0 for persons not considered previously immunized for rabies as defined in the 2008 ACIP recommendations. The 2008 ACIP recommendations for the prevention of human rabies are otherwise unchanged, and are available at: www.cdc.gov/mmwr/preview/mmwrhtml/rr57e507a1.htm
What evidence supported acceptance of these new recommendations? A panel of rabies experts conducted an extensive review of historical rabies studies and current literature concerning the pathogenesis of rabies virus, clinical vaccine trials, animal studies, epidemiologic surveillance, and health economics to determine the immunogenicity, effectiveness, and safety of a 4 dose PEP vaccination regimen. The panel found significant evidence to suggest that 4 doses of vaccine elicit an immunological response equivalent to the 5 dose series.
How does the new schedule affect people with certain primary or secondary immune deficiencies? Immunosuppressed persons (either due to illness, medication, or therapy for the illness or condition) should continue to receive rabies PEP according to the previously used 5 dose schedule. One or more serum samples should be tested for rabies virus neutralizing antibody by the rapid fluorescent focus inhibition test to ensure that an acceptable antibody response has developed after completing the series. A patient who fails to seroconvert with an acceptable antibody response after the fifth and last dose should be managed in consultation with their physician and appropriate public health officials.
Will existing vaccine product inserts be changed to reflect new ACIP recommendations? Current vaccine product labels and inserts are not expected to be changed.
Should a health care provider be concerned about off-label usage by following the new ACIP recommendations? While the new ACIP recommendations are based on evidence that support a 4 dose regimen, vaccine manufacturers likely will continue to support the product insert that was developed at the time the product was licensed by the FDA. The CDC will follow the guidance provided by the ACIP recommendations. Historically, ACIP recommendations have not always coincided with label claims and have, on occasion, made off-label recommendations based upon current scientific evidence presented to the committee.
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