CDC Announces Updated VIS for Gardasil-9 is Available
The US Centers for Disease Control and Prevention has released an updated Vaccine Information Statement (VIS) for Gardasil-9. The updated VIS contains information about the recently-approved 2-dose schedule. Otherwise, it is the same as the existing Gardasil-9 VIS. While this updated VIS should ideally begin to be used now, existing stocks of the current VIS may continue to be used, particularly for patients using the 3-dose schedule.
Vaccine providers should note that the VIS no longer specifies “Gardasil-9.” This is because Gardasil-9 will soon be the only HPV vaccine available in the U.S., as Cervarix and Gardasil (quadrivalent HPV vaccine) will no longer be sold in the United States. The appropriate VISs should continue to be used for those two vaccines as long as unexpired doses remain available.
Providers are reminded that the National Childhood Vaccine Injury (NCVI) Act requires healthcare providers do the following before administration of each vaccine listed in the Vaccine Injury Compensation Program:
- Give the appropriate VIS to the recipient or to the recipient's parent or legal representative with each dose of vaccine
- Provide the VIS prior to administration of the vaccine
- Provide the VIS each time the vaccine is given (not just with the first dose)
- Record certain information in the patient's permanent medical record
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