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 years (1). The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) reviewed the available data at its February 2019 and June 2019 in-person meetings. On June 26, 2019, ACIP voted to recommend shared clinical decision making for persons aged 27 through 45 years when considering the 9-valent HPV vaccine. This recommendation is for women who have not previously received an HPV vaccine series and who are at risk for acquisition of HPV.  HPV vaccination is most effective when given during the recommended ages of 11-12 years (2).

Obstetrician-gynecologists and other health care providers are encouraged to initiate conversations with women 27-45 years of age about the benefits of HPV vaccination. The vaccine has been shown to be safe and effective in preventing new infections with HPV in women aged 27-45 years (3). Hence, in patients aged 27 to 45 years, their decision to be vaccinated should be individually based using shared decision making and clinical judgment with consideration of those patients’ circumstances, preferences, and concerns, including the possibility of acquiring a new HPV infection. 

ACOG has liaison representation on ACIP and the ACIP HPV working group. ACOG is reviewing its clinical guidance to determine if updates are needed based on this recommendation. 

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 June 26, 2019. 
  2. Human Papillomavirus Vaccination. Committee Opinion No. 704. American College of Obstetricians and Gynecologists. Obstet Gynecol 2017;129:e17-38. Available at: https://journals.lww.com/greenjournal/fulltext/2017/06000/Committee_Opinion_
    No__704___Human_Papillomavirus.52.aspx
    . Retrieved June 26, 2019. PMID: 28346275.
         DOI: 10.1097/AOG.0000000000002052 [doi]
  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 June 26, 2019. PMID: 24391768.
         DOI: 10.1371/journal.pone.0083431 [doi]

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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