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Practice Advisory: FDA Approval of 9-valent HPV Vaccine for Use in Women and Men Age 27-45

On October 5, 2018 the FDA approved the use of the 9-valent HPV vaccine in women and men aged 27 through 45 years1. Although this approval opens the possibility for expanded protection against HPV disease in women and men, further review of the available data, including cost-effectiveness, is needed. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is reviewing the available data, and ACOG is working closely with the CDC to determine if changes in clinical guidance and recommendations are appropriate. 

In the meantime, members are advised that Committee Opinion 704, Human Papillomavirus Vaccination, remains in effect2. As outlined in the guidance, obstetrician-gynecologists and other health care providers are encouraged to welcome conversations with women older than 26 years who are interested in receiving the HPV vaccine2. In patients aged 27 to 45 years, their decision to be vaccinated should be individually based using shared decision making and clinical judgment based on those patients’ circumstances, preferences, and concerns. The vaccine is safe and is effective in preventing new infections with HPV in women aged 27-45 years3.  


This Practice Advisory was developed by the American College of Obstetricians and Gynecologists’ Immunization, Infectious Disease, and Public Health Preparedness Expert Work Group with Linda O’Neal Eckert, MD, and Kevin Ault, MD. 

References

  1. Food and Drug Administration. FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old [press release]. Silver Spring (MD): FDA; 2018. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622715.htm. Retrieved October 18, 2018.

  2. Human Papillomavirus Vaccination. Committee Opinion No. 704. American College of Obstetricians and Gynecologists. Obstet Gynecol 2017;129:e173-8. Available at: https://journals.lww.com/greenjournal/fulltext/2017/06000/Committee_Opinion_No__704___Human_Papillomavirus.52.aspx. Retrieved October 18, 2018. 

  3. Luna J, Plata M, Gonzalez M, Correa A, Maldonado I, Nossa C, et al. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil in adult women. PLoS One 2013;8:e83431. Available at: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0083431. Retrieved October 18, 2018. 


    A Practice Advisory is issued when information on an emergent clinical issue (e.g. clinical study, scientific report, draft regulation) is released that requires an immediate or rapid response, particularly if it is anticipated that it will generate a multitude of inquiries. A Practice Advisory is a brief, focused statement issued within 24-48 hours of the release of this evolving information and constitutes ACOG clinical guidance. A Practice Advisory is issued only on-line for Fellows but may also be used by patients and the media. Practice Advisories are reviewed periodically for reaffirmation, revision, withdrawal or incorporation into other ACOG guidelines. 

    This information is designed as an educational resource to aid clinicians in providing obstetric and gynecologic care, and use of this information is voluntary. This information should not be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. It is not intended to substitute for the independent professional judgment of the treating clinician. Variations in practice may be warranted when, in the reasonable judgment of the treating clinician, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology. The American College of Obstetricians and Gynecologists reviews its publications regularly; however, its publications may not reflect the most recent evidence. Any updates to this document can be found on www.acog.org or by calling the ACOG Resource Center.

    While ACOG makes every effort to present accurate and reliable information, this publication is provided “as is” without any warranty of accuracy, reliability, or otherwise, either express or implied. ACOG does not guarantee, warrant, or endorse the products or services of any firm, organization, or person. Neither ACOG nor its officers, directors, members, employees, or agents will be liable for any loss, damage, or claim with respect to any liabilities, including direct, special, indirect, or consequential damages, incurred in connection with this publication or reliance on the information presented.

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    The American College of Obstetricians and Gynecologists (ACOG), is the nation's leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of more than 58,000 members, ACOG strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women's health care. www.acog.org

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