Protocol for Human Papillomavirus Vaccine (Gardasil® 9)

Protocol for Human Papillomavirus Vaccine

(Gardasil® 9)

Oregon Board of Pharmacy – For Rulemaking Purposes Only v. 10/2023

1. What’s New

A. N/A

2. Immunization Protocol

A. Administer a 0.5-mL dose, IM, of HPV vaccine to persons ≥9 years of age.

B. HPV vaccine may be given simultaneously with all routine adolescent or adult vaccines.

3. Vaccine Schedule

HPV Vaccine

(Gardasil® 9) Dose and Route – 0.5-mL, IM

2 Dose Series

Dose

Acceptable Age Range

Dose spacing

9-14 years

5-12 months after dose 1

3 Dose Series*

15-45 years

◊

4 weeks after dose 1

3 months after dose 2 and 5 months after dose 1

*Healthy persons who begin the HPV series before their 15

birthday may complete the series

with 2 doses.

Immunocompromised persons and catch-up for persons beginning the series ≥15

years of age need 3 doses to complete series.

◊ Shared clinical decision-making regarding HPV vaccination is recommended for some adults

aged 27 through 45 years who are not adequately vaccinated.

See section 5 for guidance.

4. Licensed Vaccines

Product Name

Vaccine

Components

Presentation

FDA Approved

Age Range

Thimerosal

Gardasil® 9

Human

Papillomavirus

9-valent

Vaccine,

Recombinant

Suspension

0.5-mL single-

dose vials

0.5-mL pre-filled

syringes

9 – 45 years None

5. Recommendations for Use

A. Children and adults aged 9 through 26 years: HPV vaccination is routinely recommended at

age 11 or 12 years; vaccination can be given starting at age 9 years. Catch-up HPV

vaccination is recommended for all persons through age 26 years who are not adequately

vaccinated.

B. Adults aged >26 years: Ideally, HPV vaccination should be given in early adolescence

because vaccination is most effective before exposure to HPV through sexual activity. Catch-

up HPV vaccination is not recommended for all adults aged >26 years. Instead, ACIP

recommends HPV vaccination for persons aged 27–45 years on the basis of shared clinical

decision-making. Shared clinical decision-making refers to an individually based vaccine

Protocol for Human Papillomavirus Vaccine

(Gardasil® 9)

Oregon Board of Pharmacy – For Rulemaking Purposes Only v. 10/2023

recommendation informed by a decision-making process between the health care provider

and the patient or parent/guardian.

• Pharmacists can engage in shared clinical decision making to discuss HPV vaccination

with persons aged 27-45 years who are not adequately vaccinated and are most likely to

benefit. HPV vaccination does not need to be discussed with most adults aged >26

years. HPV vaccines are not licensed for use in adults aged >45 years.

• Pharmacists are authorized to administer HPV vaccine if one of the following risk factors

is present:

o At any age, having a new sex partner is a risk factor for acquiring a new HPV

infection

o Adults with few or no previous sex partners might not have been infected with HPV

in the past, therefore they may have a higher chance of getting HPV infection from a

new sex partner in the future

C. Special populations and medical conditions: These recommendations for children and adults

aged 9 through 26 years and for adults aged >26 years apply to all persons, regardless of

behavioral or medical risk factors for HPV infection or disease. For persons who are

pregnant, HPV vaccination should be delayed until after pregnancy; however, pregnancy

testing is not needed before vaccination. Persons who are breastfeeding or lactating can

receive HPV vaccine.

6. Contraindications

A. Severe allergic reaction (e.g., anaphylaxis) to a previous dose or to any vaccine component.

B. Hypersensitivity to yeast

C. Pregnancy: HPV vaccines should not be administered during pregnancy. Exposure during

pregnancy can be reported to the Merck Pregnancy Registry at 1-800-986-8999.

7. Warnings and Precautions

A. Vaccination of people with moderate or severe acute illnesses should be deferred until after

the illness improves.

B. Syncope after immunization is common among adolescents. Have the client sit for 15

minutes after vaccination

8. Other Considerations

A. Individuals with altered immunocompetence may have reduced immune responses.

B. Cervical cancer screening should be initiated at 21 years and continuing through age 65

years for both vaccinated and unvaccinated women.

C. Women with an equivocal or abnormal pap test, positive Hybrid Capture II® high-risk test or

genital warts can receive HPV vaccine. Recipients should be advised that the vaccine has no

therapeutic value and will only provide protection against infection with HPV types not

already acquired.

Protocol for Human Papillomavirus Vaccine

(Gardasil® 9)

Oregon Board of Pharmacy – For Rulemaking Purposes Only v. 10/2023

9. Side Effects and Adverse Reactions

Adverse Event

Frequency

Injection Site Reactions

Pain, redness, or swelling at vaccination site

Up to 90%

Systemic Adverse Reactions

Low-grade fever of up to 101⁰F

Up to 10%

Fever of 102⁰F or more

Up to 1.5%

10. Storage and Handling

A. Store medications according to OAR 855-041-1036.

B. All clinics and pharmacies enrolled with the Vaccines for Children (VFC) Program must

immediately report any storage and handling deviations to the Oregon Immunization

Program at 971-673-4VFC (4823).

Vaccine

Temp

Storage Issues

Notes

Gardasil® 9

Store at 2°to 8°C (36°

to 46°F)

Do not freeze, protect

from light

Administer as soon as possible

after being removed from

refrigeration

11. References

1. Merck and Company, HPV 9 (Gardasil ®9) 2014 package insert. Available at:

https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Package-Insert-

--Gardasil.pdf. Accessed 5 June 2023.

2. Meites E, Kempe A, Markowitz LE. Use of a 2-dose schedule for human papillomavirus

vaccination: updated recommendations of the Advisory Committee on Immunization

Practices. MMWR 2016; 65:1405–8. Available at:

http://dx.doi.org/10.15585/mmwr.mm6549a5

Accessed 5 June 2023.

3. Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human

Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory

Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2019;68:698–702.

Available at: http://dx.doi.org/10.15585/mmwr.mm6832a3

Accessed 23 July 2023.

4. Ezeanolue E, Harriman K, Hunter P, Kroger A, Pellegrini C. General Best Practices Guidelines

for Immunization. Available at:

https://www.cdc.gov/vaccines/hcp/acip-recs/general-

recs/index.html Accessed 5 June 2023.

5. Human papillomavirus vaccination: recommendations of the Advisory Committee on

Immunization Practices (ACIP). MMWR 2014; 63(RR05). Available at:

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6305a1.htm

Accessed 5 June 2023.

6. Petrosky E, Bocchini JA, Hariri S, Chesson H, Curtis CR, Saraiya M, et al. Use of 9-valent

human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the

Advisory Committee on Immunization Practices. MMWR 2015; 64;300–4. Available at:

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6411a3.htm

Accessed 5 June 2023.

Protocol for Human Papillomavirus Vaccine

(Gardasil® 9)

Oregon Board of Pharmacy – For Rulemaking Purposes Only v. 10/2023

12. Appendix

A. Centers for Disease Control and Prevention (CDC). Shared Clinical Decision-Making HPV

Vaccination for Adults Aged 27-45 Years: Job Aid for Healthcare Professionals. Atlanta, GA:

US Department of Health and Human Services, CDC; 2019.

https://www.cdc.gov/vaccines/hcp/admin/downloads/ISD-job-aid-SCDM-HPV-shared-

clinical-decision-making-HPV.pdf