Current Controversies in the USA Regarding Vaccine Safety

Archana Chatterjee; Catherine O'Keefe


Expert Rev Vaccines. 2010;9(5):497-502. 

In This Article

Human Papillomavirus Vaccine: A Battle between Policy & Parents

Human papillomavirus (HPV) is the most common sexually transmitted disease and is most widely known for its association with cervical cancer. There are more than 120 genotypes of HPV with approximately 30 affecting at least half of sexually active individuals. Of the 30 types, 12 can cause cervical cancer.[26] Four HPV genotypes have been targeted for vaccine development: 6, 11, 16 and 18. HPV-6 and -11 cause anogenital warts and, if transmitted vertically from a mother to her infant, may cause juvenile recurrent respiratory papillomatosis.[26]

The first HPV vaccine was licensed by Merck, NJ, USA (Gardasil®) in 2006 and was heralded by many as the most important anticancer vaccine since the hepatitis B vaccine. A second bivalent (HPV types 16 and 18) vaccine, Cervarix® (GlaxoSmithKline, London, UK), has recently been licensed by the US FDA. However, controversies and questions concerning safety as well as parental attitudes have contributed to the relatively low HPV vaccine uptake – 17.9% of vaccine-eligible young women aged 13–17 years and 9.9% aged 18–26 years.[27,103]

Gardasil is a quadrivalent vaccine (serotypes 6, 11, 16 and 18) and approved for use in females, ages 9–26 years. It has been recommended by the Advisory Committee on Immunization Practices (ACIP) of the CDC and endorsed by the AAP and the AAFP since 2007.[28]

Follow-up studies have revealed a 98–99% efficacy rate for Gardasil.[29,30] Post-licensure safety data for this vaccine as reported by the federal Vaccine Adverse Event Reporting Systems has been similar to other vaccine post-licensure data.[31] The question arises as to the acceptability of any vaccine risk with a disease that can be prevented by an active screening process. The answer lies within a medical system that has been unsuccessful in reducing the incidence of HPV-associated disease through routine screening.[32]

Public health, politics and parents have clashed and created a significant obstacle to the widespread acceptance of the HPV vaccine. Shortly after the licensure of the HPV vaccine, several states began introducing legislation to mandate HPV vaccination for school-aged girls.[33] This action prompted a groundswell of opposition from the lay public and immersed the HPV vaccine in controversy. Parents and some healthcare providers argue that receipt of the HPV vaccine should be a matter of individual choice, particularly since the vaccine is designed to prevent a sexually transmitted infection. Opponents proclaim that the HPV vaccine promotes early initiation of sexual activity and/or increased promiscuity.[104]

The reality is that young people engage in risky sexual behavior that can have devastating effects on their health well into adulthood.[34] A government study of abstinence-only education in middle schools revealed that within 4–6 years after the program, an equal number of participants versus controls had experienced sexual activity with the mean age of 14.9 years of age for first sexual activity.[105] The 2005 US Youth Risk Behavior Survey has reported similar findings with a median of 3.6% of females reporting experiencing their first sexual encounter before 13 years of age.[35] The National Health and Nutrition Examination Survey (NHANES) interviewed adults regarding sexual behavior and reported that 20% of 20–29-year-olds had engaged in sexual activity before 15 years of age.[106] An even harsher reality is that young children can become infected with HPV after being subjected to involuntary sexual activity due to rape, incest or other unwanted genital contact.[34]


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