Clinical Practice: The 9-Valent HPV Vaccine

On February 26, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted in favor of provisional recommendations for the routine use of a new 9-valent HPV vaccine in girls and boys as well as young adult males and females.

The 9-valent HPV vaccine, licensed by the Food and Drug Administration (FDA) in December 2014, covers five additional strains of HPV not covered in its quadrivalent-valent counterpart. The vaccine is licensed by the FDA for use in females age 9 to 26 years, and in males age 9 to 15 years1. Clinical trials have shown that it can prevent even more cancer-causing virus types than its quadrivalent and bivalent predecessors. Moreover, recent studies have conclusively demonstrated the safety of the HPV vaccine.

The new recommendations from ACIP remain provisional, pending the approval of the CDC director. To respond to this new information, ACOG issued a Practice Advisory on the new 9-valent HPV vaccine developed with subject matter experts. ACOG will continue to review this evolving issue and CDC’s forthcoming final published recommendations. Should ACOG’s guidance on HPV vaccination be updated, it will be published in Obstetrics & Gynecology.

Increasing HPV Vaccination Rates

As ACOG monitors emerging evidence to support adoption of the 9-valent vaccine, the College continues to encourage ob-gyns to play a leading role in driving HPV vaccinations in adolescent girls and boys, which remain strikingly low compared to other routinely recommended adolescent vaccines.

In 2013, coverage of at least one dose of HPV vaccine was 57.3% among adolescent girls and 34.6% among adolescent boys2. According to the CDC, for every year that coverage does not increase, an additional 4,400 women will develop cervical cancer3. Furthermore, if health care providers increase HPV vaccination coverage to 80%, it is estimated that an additional 53,000 cases of cervical cancer could be prevented during the lifetime of those younger than 12 years3. These data highlight the overwhelming importance of HPV vaccination efforts, including discussions with patients and parents of adolescents and young adults about the benefit of HPV immunization for cancer prevention.

HPV vaccination in pregnancy is not recommended. Currently, there are few data on HPV vaccine administration in pregnancy; however, the available safety data regarding the inadvertent administration of the vaccine during pregnancy are reassuring.

ACOG has developed several tools for providers and patients to increase HPV vaccination rates:

1. Merck & Company, Inc. Gardasil 9: highlights of prescribing information. Whitehouse Station (NJ): Merck; 2014. Available at:

2. Human papillomavirus vaccination coverage among adolescents, 2007–2013, and postlicensure vaccine safety monitoring, 2006–2014 - United States. Centers for Disease Control and Prevention (CDC).  MMWR Morb Mortal Wkly Rep 2014;63:620-4

3. Human papillomavirus vaccination coverage among adolescent girls, 2007–2012, and postlicensure vaccine safety monitoring, 2006–2013 - United States. Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep 2013;62:591–5.

American Congress of Obstetricians and Gynecologists
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