Ensure your EHR systems are being updated to align with CDC guidance for HPV vaccination for adults aged 27-45 years¹

The updated CDSi (Clinical Decision Support for Immunization) will now state “Not Complete”a instead of “Aged Out”b as the patient series status for unvaccinated adults aged 27-45 years2,3

a“Not Complete” is a patient series status that indicates the patient has not yet met all of the ACIP recommendations for the patient series.³

Consult your IT/EHR team to incorporate this update into your system

CDSi translates clinical recommendations into technical decision-making support⁴

What does this update mean for your HPV vaccination conversation?

CDC recommendation for adults¹

Shared clinical decision-making (SCDM)²

  • flexible
  • informed by characteristics, values, and preferences of the patient
  • supported with clinical discretion

Recommend HPV vaccination to all appropriate adults aged 27-45


References:

  1. Recommended adult immunization schedule for ages 19 years or older, United States, 2024. Centers for Disease Control and Prevention. Addendum updated June 27, 2024. Accessed August 21, 2024. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/adult/adult-combined-schedule.pdf
  2. CDSi Supporting Data Version 4.56: Antigen Supporting Data – HPV-508. Centers for Disease Control and Prevention. July 11, 2024. Accessed August 21, 2024. https://www.cdc.gov/iis/cdsi/
  3. CDSi logic specification for ACIP recommendations. Centers for Disease Control and Prevention. February 23, 2024. Accessed August 22, 2024. https://www.cdc.gov/iis/downloads/logic-spec-acip-rec-4.5.pdf
  4. Clinical decision support for immunization (CDSi). Centers for Disease Control and Prevention. Last reviewed August 6, 2024. Accessed August 9, 2024. https://www.cdc.gov/vaccines/programs/iis/downloads/CDSi-miniGuide.pdf
  5. Clinical decision support for immunization (CDSi). Centers for Disease Control and Prevention. Last reviewed August 6, 2024. Accessed August 22, 2024. https://www.cdc.gov/iis/cdsi/
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Indication

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

 

GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

 

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

 

GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

 

GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:

  • HPV types not covered by the vaccine
  • HPV types to which a person has previously been exposed through sexual activity

 

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

 

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

 

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

Select Safety Information

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

 

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.

 

Safety and effectiveness of GARDASIL 9 have not been established in pregnant women.

 

The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema.

 

The duration of immunity of a 2-dose schedule of GARDASIL 9 has not been established.

 

Dosage and Administration for GARDASIL 9

 

GARDASIL 9 should be administered intramuscularly in the deltoid or anterolateral area of the thigh.

  • For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months.
  • For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months.

 

Before administering GARDASIL 9, please read the Prescribing Information. The Patient Information also is available.

Indication

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

 

GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

 

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

 

GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

 

GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:

  • HPV types not covered by the vaccine
  • HPV types to which a person has previously been exposed through sexual activity

 

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

 

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

 

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is a vaccine for patients 9 through 45 years of age for the prevention of certain cancers and other diseases caused by 9 types of human papillomavirus (HPV).

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Click to view full Indication.

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is a vaccine for patients 9 through 45 years of age for the prevention of certain cancers and other diseases caused by 9 types of human papillomavirus (HPV).

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Click to view full Indication.

Select Safety Information

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

 

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.

 

Safety and effectiveness of GARDASIL 9 have not been established in pregnant women.

 

The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema.

 

The duration of immunity of a 2-dose schedule of GARDASIL 9 has not been established.

 

Dosage and Administration for GARDASIL 9

 

GARDASIL 9 should be administered intramuscularly in the deltoid or anterolateral area of the thigh.

  • For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months.
  • For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months.

 

Before administering GARDASIL 9, please read the Prescribing Information. The Patient Information also is available.

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or

GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or  GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].