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Updated ACOG Recommendations for Human Papillomavirus Vaccine

Human papillomavirus (HPV) infection is linked to the development of cervical, vaginal, vulvar, penile, anal, and oropharyngeal cancer, as well as genital warts. Vaccination against HPV has been shown to lower the incidence of anogenital cancer and genital warts, and it may also reduce the incidence of oropharyngeal cancer and maternal passage of HPV to infants.

Cervical cytology screening in the United States has shown nearly 2.8 million abnormal Papanicolaou test results each year, with more than 12,000 diagnoses of cervical cancer and nearly 4000 deaths from the disease. The American College of Obstetricians and Gynecologists (ACOG) has issued a Committee Opinion regarding unacceptably low rates of and recommendations for HPV vaccination. This Opinion updates the college’s previous recommendations in March 2014.
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STUDY SYNOPSIS AND PERSPECTIVE

A key role of obstetrician-gynecologists and other healthcare providers is to provide patients and their parents with information on the benefits and safety of the HPV vaccine and to encourage adolescents to receive the HPV immunization, according to updated recommendations published online July 6 by ACOG.

“Current vaccination rates are unacceptably low,” write ACOG’s Committee on Adolescent Health Care and Immunization Expert Work Group. “Studies have shown that physicians’ recommendations play a crucial role in the acceptance of HPV vaccination by patients and parents of patients.”

The committees updated the March 2014 recommendations to include the new 9-valent HPV vaccine, also recommended by the Centers for Disease Control and Prevention (CDC) for girls and boys 11 to 12 years old. Those who do not receive the HPV vaccine during the target age range should undergo catch-up vaccination until age 26 years.

The US Food and Drug Administration licensed the new formulation, Gardasil 9, in December 2014. The new vaccine protects against the original 4 strains in the quadrivalent vaccine, as well as 5 additional strains, all of which are responsible for cervical, vulvar, vaginal, penile, and anal cancers. Another earlier bivalent vaccine protects against strains 16 and 18, which are responsible for the majority of cervical cancers. The 9-strain vaccine is more than 99% effective in reducing HPV disease from strains 6, 11, 16, and 18, and it is 96.7% effective in reducing disease from strains 31, 33, 45, 52, and 58.

Despite existing recommendations for HPV vaccination in adolescents, only approximately 50% of US girls between 13 and 17 years old have received at least 1 dose, and 33% have received all 3 doses. The CDC estimates that an immunization rate of at least 80% would prevent an additional 53,000 cases of cervical cancer during the lifetimes of those currently younger than 12 years.

Neither the CDC’s Advisory Committee on Immunization Practices nor ACOG routinely recommends that anyone receive the 9-strain vaccine if he or she received all 3 doses of the previous vaccine. However, providers can use the 9-strain vaccine to complete any series for boys or girls who received 1 or 2 doses of the earlier vaccines.
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The safety profile of the 9-strain vaccine resembles that of the quadrivalent vaccine, with the exception of greater redness and swelling at the injection site in the newer vaccine. After more than 60 million doses of HPV vaccine administered, “there are no data to suggest that there are any severe adverse effects or adverse reactions linked to vaccination,” the committee writes. “Obstetrician–gynecologists or other providers should counsel patients to expect discomfort after vaccination and that such discomfort is not a cause for concern,” they write, although anyone with a previous life-threatening reaction to the HPV vaccine or its components, including yeast, should not receive the vaccine.

The committee does not recommend routine pregnancy testing or routine HPV testing before a patient receives the vaccine, and those in the target age range who may already have a positive HPV DNA test result should still receive the vaccine. Despite reassuring safety data for HPV vaccination during pregnancy, ACOG recommends that women do not receive the vaccine while pregnant. Lactating women may receive it.

STUDY HIGHLIGHTS

• The CDC and ACOG recommend that girls and boys routinely receive HPV vaccination.
• The US prevalence of vaccine-type HPV decreased by 56% among girls 14 to 19 years old from 2006 (when the quadrivalent HPV vaccine was introduced) and 2010.
• The Advisory Committee on Immunization Practices has subsequently recommended use of the new, nanovalent HPV vaccine.
• The US Food and Drug Administration licensed this vaccine in December 2014 for use in girls and boys 11 to 12 years old.
• The nanovalent HPV vaccine protects against the 4 strains originally in the quadrivalent vaccine and 5 additional strains implicated in anogenital cancers.
• Most cases of all HPV-associated cancer are caused by genotypes 16 and 18, and approximately 90% of cases of genital warts are caused by genotypes 6 and 11.
• The efficacy of the nanovalent HPV vaccine exceeds 99% for strains 6, 11, 16, and 18 and is 96.7% for strains 31, 33, 45, 52, and 58.
• Despite the benefits of HPV vaccines in reducing the incidence of anogenital cancer and genital warts, only 33% of US girls in the recommended age group (13 – 17 years) have received all 3 vaccine doses, and only 50% have received at least 1 vaccine dose.
• ACOG describes US vaccination rates for HPV as “unacceptably low” compared with other vaccines recommended for persons in the same age range.
• The CDC estimates that if HPV vaccination coverage increases to 80%, an additional 53,000 cases of cervical cancer could be prevented during the lifetime of those younger than 12 years, and for every year that coverage does not increase, an additional 4400 women will go on to have cervical cancer.
• ACOG states that it is “crucial” that obstetrician-gynecologists and other members of the healthcare team inform their young patients and their parents regarding the benefits and safety of HPV vaccination.
• The Advisory Committee on Immunization Practices has added use of nanovalent HPV vaccine to its recommendations for girls and boys at the target age of 11 to 12 years, with catch-up vaccination through age 26 years for persons not vaccinated at the target age.
• The nanovalent vaccine is unnecessary for persons who received all 3 doses of earlier HPV vaccine but may be used to complete any series for persons who received only 1 or 2 doses of previous vaccines.
• Routinely testing for pregnancy or for HPV DNA is not recommended before HPV vaccination in any group.
• Patients testing positive for HPV DNA should still undergo vaccination.
• Pregnant women should not be vaccinated, although safety data for HPV vaccination during pregnancy are reassuring.
• Breastfeeding women may be vaccinated for HPV.
• A history of life-threatening reactions to the HPV vaccine, to yeast, or to any of the other vaccine components is a contraindication to vaccination.
• Compared with the quadrivalent vaccine, the nanovalent vaccine is associated with an increased rate of injection site erythema and swelling, which increases after each successive dose.
• Otherwise, both vaccines have a similar safety profile, with no reports of severe adverse effects.
• Immunosuppression is not a contraindication to HPV vaccination, but the immune response may be less robust in these patients.

CLINICAL IMPLICATIONS

• An ACOG Committee Opinion describes HPV vaccination rates in the United States as “unacceptably low” compared with other vaccines recommended for persons in the same age range.
• ACOG recommends that girls and boys receive nanovalent HPV vaccine at the target age of 11 to 12 years, with catch-up vaccination for girls and boys through age 26 years if they were not vaccinated at the target age.
• Implications for the Healthcare Team: The ACOG states that it is “crucial” that obstetrician-gynecologists and other members of the healthcare team inform their young patients and their parents regarding the benefits and safety of HPV vaccination.