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.

   Source: https://www.acog.org/Clinical-Guidance-and-Publications/Practice-Advisories/Practice-Advisory-FDA-Approval-of-9-valent-HPV-Vaccine-for-Use-in-Women-and-Men-Age-27-to-45