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Position Statement: Recurrent Respiratory Papillomatosis and Gardasil Vaccination

Position Statement: Recurrent Respiratory Papillomatosis and Gardasil Vaccination

Recurrent respiratory papillomatosis (RRP) is characterized by recurrent papillomatous lesions that grow primarily on the vocal folds but may involve other parts of the upper airway.(1-2) This disease can affect both children and adults.(1-2) Although it is a benign disease, malignant transformation has been reported.(3) Some patients may only require limited surgical treatment, while others may require numerous treatments per year for several years, to achieve and maintain some degree of disease control.(1-2) Both the disease and the surgical therapy can cause irreversible damage, including poor voice quality and/or airway compromise. Such outcomes have been associated with social withdrawal and depression, and have been shown to have a negative influence on social, emotional, educational, and occupational outcomes.(4-5) The annual cost of RRP for children in the United States is estimated to be between $40 million and $123 million.(6)

RRP is most commonly caused by the human papillomavirus (HPV) subtypes 6 and 11.(1-2) This virus is widespread and as many as 80% of adults will be infected with HPV at some point during their lives if they are not vaccinated against the virus.(7) 

In 2014, an HPV vaccine, Gardasil-9, was approved by the Food and Drug Administration (FDA) for use in female and male patients 9-26 years of age and expanded their recommendation to include those 27-45 years in 2018 for the prevention of genital warts and cervical cancer.(8) Since then, other potential benefits have been noted, such as prevention of some head and neck cancers and the prevention and control of RRP since the vaccine covers the subtypes most commonly found to cause these conditions.(8) Several studies have suggested a therapeutic advantage of Gardasil-9 for adults and children with RRP. It has been noted to decrease the number of surgeries needed in those with RRP and to increase the length of time between the surgeries.(3) This benefits both the patient, and society as a whole by decreasing the use of healthcare resources and missed days of school and work due to RRP.

The Center for Disease Control and Prevention states that HPV vaccination is safe and effective and continues to closely monitor the safety of this vaccine.(9)

Given the potential benefits of Gardasil-9 for prevention and treatment of RRP, the American Academy of Otolaryngology–Head & Neck Surgery supports the use of Gardasil-9 HPV vaccination in all patients 9-45 years of age.  It’s use in those under 9 and over 46 should be considered as “off-label” and only used with shared-decision making or as part of a clinical trial.

Adopted 7/14/2020

References

1. Derkay CS, Wiatrak B. Recurrent respiratory papillomatosis: a review. Laryngoscope. 2008;118(7):1236-47.

2. Derkay CS, Bluher AE. Update on Recurrent Respiratory Papillomatosis. Otolaryngol Clin North Am. 2019;52(4):669-679.

3. Rosenberg T, Philipsen BB, Mehlum CS et al. Therapeutic Use of the Human Papillomavirus Vaccine on Recurrent Respiratory Papillomatosis: A Systematic Review and Meta-Analysis. The Journal of Infectious Disease. J Infect Dis. 2019; 15;219(7):1016-102

4. Zacharias S, Kelchner LN, Creaghead N. Teachers’ perceptions of adolescent females with voice disorders. Lang Speech Hear Serv Sch. 2013;44:174–82.

5. van Nieuwenhuizen AJ1, Rinkel RN, de Bree R, Leemans CR, Verdonck-de Leeuw IM. Patient reported voice outcome in recurrent respiratory papillomatosis. Laryngoscope. 2010;120(1):188-92. doi: 10.1002/lary.20662.

6 Bishai D, Kashima H, Shah K. The cost of juvenile-onset recurrent respiratory papillomatosis. Arch Otolaryngol Head Neck Surg. 2000; 126(8):935-9

7.Chesson HW, Dunne EF, Hariri S, Markowitz LE. The estimated lifetime probability of acquiring human papillomavirus in the United States. Sex Transm Dis. 2014;41(11):660-4

8. Centers for Disease Control and Prevention. Safety Information by Vaccine – Human Papillomavirus (HPV) Vaccin. Available at https://www.cdc.gov/vaccinesafety/vaccines/hpv-vaccine.html. Accessed 05-01-2020.

9. U.S. Food and Drugs Administration (FDA). Gardasil. Available at https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9. Accessed 05-01-2020.

Important Disclaimer Notice (Updated 7/31/14)

Position statements are approved by the American Academy of Otolaryngology—Head and Neck Surgery or Foundation (AAO-HNS/F) Boards of Directors and are typically generated from AAO-HNS/F committees. Once approved by the Academy or Foundation Board of Directors, they become official position statements and are added to the existing position statement library. In no sense do they represent a standard of care. The applicability of position statements, as guidance for a procedure, must be determined by the responsible physician in light of all the circumstances presented by the individual patient. Adherence to these clinical position statements will not ensure successful treatment in every situation. As with all AAO-HNS/F guidance, this position statement should not be deemed inclusive of all proper treatment decisions or methods of care, nor exclusive of other treatment decisions or methods of care reasonably directed to obtaining the same results. Position statements are not intended to and should not be treated as legal, medical, or business advice.