This article is more than 5 years old. Information may no longer be current.

HPV vaccine: Three shots at disease prevention

Issue: February 2016

ByKimberly Boeser, PharmD, MPH, BCIDP

ByRebecca Nolen, PharmD, BCPS

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Sexually transmitted diseases continue to pose a significant health risk in the U.S. It is estimated that 19 million new infections occur annually, many of them in young adults aged 15 to 24 years. These statistics may be underestimated as some viral diseases, such as HPV, are believed to be underreported to the CDC.

HPV is the most common STD in the U.S. with an estimated 14.1 million new cases in the country annually. There are more than 100 types of HPV, and more than 40 types are considered sexually transmitted and infect the genital tract. HPV infections are divided into low-risk, nononcogenic HPV infections, which cause genital warts, and high-risk oncogenic HPV infections, which cause cervical, penile, vulvar, vaginal, anal and oropharyngeal cancers and precancers. Most low-risk HPV infections (ie, HPV types 6 and 11) are self-limited or asymptomatic. High-risk HPV infections (ie, HPV types 16 and 18) are associated with cervical cellular changes, Pap test abnormalities and cervical dysplasia. The most effective method for managing this infectious disease and its complication is disease prevention by vaccination.

Comparison of the vaccines

Currently, three HPV vaccines are available on the U.S. market — a quadrivalent (4vHPV; Gardasil, Merck), bivalent (2vHPV; Cervarix, GlaxoSmithKline) and 9-valent (9vHPV; Gardasil 9, Merck) vaccine. 4vHPV was the first HPV vaccine to enter the U.S. market and has been available for use in females since 2006 and in males since 2009. In 2009, 2vHPV also entered the market for use in females. In late 2014, 9vHPV also was licensed in the U.S. 4vHPV prevents infection with HPV types 6, 11, 16 and 18 and is indicated for girls and women as well as boys and men aged 9 to 26 years. 9vHPV offers protection against the two most common types of HPV (16 and 18), which cause 66% of cervical cancers, as well as five additional types (31, 33, 45, 52 and 58), which cause 15% of cervical cancers. 9vHPV also protects against two HPV types that cause genital warts (6 and 11) and carries the same indications for age and sex as 4vHPV. 2vHPV, which protects against HPV types 16 and 18, is only FDA approved for females aged 9 to 25 years.

Each of the HPV vaccines consists of a three-vaccine administration schedule via intramuscular injection. 4vHPV and 9vHPV are given at 0, 2 and 6 months, while the 2vHPV is given at 0, 1 and 6 months. A national survey conducted in 2014 found that 60% of females aged 13 to 17 years had received at least one dose of HPV vaccine, and 40% had received all three doses in the series. These percentages are lower in males than females — 42% vs. 22%, respectively. Despite the fairly low use of HPV vaccines, the prevalence of HPV types 6, 11, 16 and/or 18 decreased from 11.5% before the vaccines were available to 5.1% after the vaccines entered the market in females aged 14 to 19 years.

One adverse reaction that is common among the vaccines is syncope, so patients should be monitored for 15 minutes after the administration of the vaccine. The most common adverse reaction for all of the vaccines includes pain, redness and swelling at the injection site. Pain at the injection site was noted in more than 70% of patients during clinical trials of all of the HPV vaccines. There is a lack of data to recommend the coadministration of any HPV vaccine with other vaccines; however, 4vHPV has been studied and safely used with hepatitis B vaccine (Recombivax HB, Merck), meningococcal quadrivalent vaccine (Menactra, Sanofi Pasteur) and tetanus-diphtheria-acellular pertussis vaccine (Adacel, Sanofi Pasteur). Similarly, 9vHPV was tested with Menactra and Adacel, and coadministration of these vaccines was found to be safe and effective.

All of the HPV vaccines carry a pregnancy category B because reproduction studies have been performed with high doses of the vaccines in rats without evidence of impaired fertility. However, there is a lack of controlled trials studying the use of HPV vaccines in pregnant humans, so they should only be administered during pregnancy if clearly necessary.

ACIP/CDC recommendations

Although the vaccine series can be started as early as age 9 years, the Advisory Committee on Immunization Practices (ACIP) recommends routine HPV vaccination starting at age 11 or 12 years. ACIP also recommends vaccination for females aged 13 to 26 years and males aged 13 to 21 years who are not previously vaccinated. Vaccination is also recommended through age 26 years for men who have sex with men and for immunocompromised persons if not previously vaccinated. ACIP recommends the 2vHPV, 4vHPV and 9vHPV for females and only 4vHPV or 9vHPV vaccine for males.

HPV vaccines provide protection against up to nine infection- and cancer-causing types of HPV that infect millions of people throughout the U.S. each year. Although rates of compliance with the ACIP recommendations are fairly low, vaccine-preventable types of HPV infections and cancers have decreased since the vaccines became available in the U.S. Improved adherence to the three-vaccine regimen can help further decrease the risk for vaccine-preventable HPV.

• References:
• Cervarix Package Insert. GlaxoSmithKline. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Cervarix/pdf/CERVARIX-PI-PIL.PDF. Accessed January 19, 2016.
• Department of Health and Human Services, Office of Disease Prevention and Health Promotion. Healthy People 2020-Sexually Transmitted Diseases. http://www.healthypeople.gov/2020/topics-objectives/topic/sexually-transmitted-diseases. Accessed January 20, 2016.
• Gardasil Package Insert. Merck. http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf. Accessed January 19, 2016.
• Gardasil-9 Package Insert. Merck. https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf. Accessed January 19, 2016.
• Petrosky, E, et al. MMWR Morb Mortal Wkly Rep. 2015;64:300-304.

• For more information:
• Rebecca Nolen, PharmD, BCPS, is the PGY2 infectious diseases pharmacy resident at the University of Minnesota Medical Center-M Health.
• Kimberly D. Boeser, PharmD, BCPS AQ-ID, is an infectious diseases clinical pharmacist and antimicrobial stewardship coordinator at the University of Minnesota Medical Center-M Health

Disclosures: Boeser and Nolen report no relevant financial disclosures.