The human papilloma virus (HPV) is an exceedingly common and potentially serious and fatal infection. The Centers for Disease Control and Prevention (CDC) estimates that nine out of ten individuals will be infected during their lifetime. There are over 200 serotypes of HPV, but only a few specific serotypes are associated with cancer in women and men. Specifically two serotypes, 16 and 18, are associated with over 70% of cervical, vulvar, penile, anal and oropharyngeal cancers
Vaccines: There are three currently licensed vaccines against HPV
- Gardasil contains 4 serotypes (16,18 and 6, 11 which are associated with anogential warts). It was released in 2006 after studies in over 29,000 females and males
- Cevarix contains serotypes 16 and 18. It was released in 2009 after studies in 30,000 females
- Gardasil 9 contains nine serotypes (16,18,6,11,31,33,45,52,58) and was released in 2014 after studies in over 15,000 females and males.
Immunization: The Advisory Committee on Immunization Practice (ACIP) and the CDC recommend a three dose series for both girls and boys starting at age 11 or 12. The vaccines can be given as early as 9 years of age. CDC estimates that only about 42% of teen girls and 28% of teen boys receive all three doses. Recently, CDC has indicated that a two dose series rather than a three dose series for children under 15 years of age is a reasonable option for boosting immunization rates. CDC also estimates that over 29,000 cancers and 4800 deaths are preventable annually through vaccination. Given the above rates, that means that over 2000 children each year who are unvaccinated potentially will become adults that die from these preventable forms of cancer.
Vaccine Safety: Cumulatively, HPV vaccines have been studies for both efficacy and safety in over 74,000 patients. In addition, CDC maintains a Vaccine Adverse Event Reporting System to do surveillance on possible adverse events. Through March 2016, 90 million doses of HPV vaccine have been given. Most reported adverse events were side effects of the vaccine including fainting (vaccine now recommended to be given in sitting position), dizziness, headache, nausea, fever, and redness and swelling at the injection site. Surveillance has addressed some early concerns such as infertility, STD and pregnancy, Guillian Barre Syndrome and Postural Orthostatic Tachycardia (POTS) syndrome. Surveillance indicates that HPV vaccines are NOT related to ovarian failure and infertility, NOR excess sexual activity and increased risk of sexually transmitted diseases, NOR associated with development of Guillan Barre Syndrome or POTS.
The MYTH: Despite 10 years of experience with HPV vaccines and nearly 100 million doses, one myth persists which is fanned by the media based on small cohort studies done largely in Europe. This is that HPV vaccination increases risk of chronic pain syndromes including fibromyalgia and chronic regional pain syndrome. Similar to the disturbing derailing of measles immunization following the Wakeman study in the UK that incorrectly linked MMR vaccines to autism, the media, the anti-vaccination movement, and some governments (e.g. Japan) have picked up on poor science and drawn incorrect and dangerous conclusions regarding the link of HPV vaccines with chronic pain syndromes. The most recent entry into this misinformation parade has been a small study (18 women) in Italy who developed fibromyalgia after HPV vaccine, although a mechanism is unproven, and causal criteria not met. In November 2015, the European Medicine Agency conducted a review on HPV vaccines and found NO causative link between vaccines and chronic pain syndromes including fibromyalgia. The CDC vaccine surveillance systems likewise have not found any association of HPV vaccines and chronic pain syndromes. It is important to note that none of the few studies published to claim relationship between HPV vaccination and chronic pain syndromes meet the established Bradford-Hill criteria for cause-effect, and at best, represent weak associations.1
Effect of the MYTH: As with the MMR-autism myth, the effects can be devastating. In the UK, the publication of the Wakefield study was followed by a sharp decline in measles immunization rates in Wales (which had been in the 90% range) and a measles outbreak. If we allow our hesitancy to talk about a sexually transmitted disease that can be prevented and its devastating sequelae of cancer prevented, we are not doing our duty as protectors of our patients’ and society’s health. Public health officials and quality agencies are now recognizing the critical importance of improving HPV immunization rates. For instance, NCQA has now incorporated HPV into the the adolescent immunization measure along with meningococcal immunization. So you now have two compelling reasons to address the HPV immunization status of your adolescent patients- protecting the maturing adolescent from HPV related infection in the short term and cancer later in life, AND improving your quality scores that will enable you to earn higher quality incentive bonuses.
- Bradford-Hill criteria. Journal of Royal Society of Medicine, 1965, 58: 295-300