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Economic impact of HPV HPV is the second most expensive STI and is only surpassed in expense by the cost of treatment of HIV / AIDS (CDC, 2022d). Many HPV-infected people have no obvious signs or symptoms so establishing HPV detection and prevention programs has been challenging and the United States Food and Drug Administration has only approved tests for HPV for potential involvement for the cervix (ACS, 2020). Cervical cancer screening and follow-up treatment alone is estimated to cost the nation $6.6 billion dollars which accounts for approximately 80% of all costs involved for preventing and treating diseases of HPV-origin. Thus,

treatment and screening for all HPV-related diseases is approximately $8 billion in medical costs for all HPV-related diseases (Coyne-Beasley and Hochwalt, 2016). Recurrent respiratory papillomatosis (RRP) is a condition that occurs in infants born to mothers with a cervical HPV in which wart-like growths develop in the airway. The prevalence is 4.3 per 100,000 and in children and 1.8 per 100,000 adults with annual cost between $40-$123 million for the treatment of all (RRP) patients (Benedict & Derkay, 2020). Table 8 provides additional information on the annual direct medical costs of preventing and treating HPV-related disease.

Table 8: Estimated Annual Direct Medical Costs of Preventing and Treating HPV-Related Disease HPV-Related Disease Number of Cases Cost Per Case Annual Cost (Millions)

Cost Burden (%)

Cervical screening: Routine Cervical Screening: Follow-up

52 million

$103

$5,356 $1,224

67.0 15.3

NA

NA

Cervical cancer

11,370

$38,800 $43,200 $36,200 $23,600 $27,100 $19,800

$441 $306 $155

5.5 3.8 1.9 0.5 0.2 0.1 3.6

Oropharyngeal cancer

7,080 4,270 1,560

Anal cancer Vulvar cancer Vaginal cancer Penile cancer Genital warts

$37 $12

460 360

$7

355,000

$810

$288

Recurrent papillomatosis (adult and juvenile)

NA

$150,000

$171

2.1

Total Cost Burden 100 Note . Adapted from “Estimates of the Annual Direct Medical Costs of the Prevention and Treatment of Disease Associated with Human Papillomavirus in the United States,” by H. Chesson, D. Ekwueme, M. Saraiya, M. Watson, and D. Lowry, Vaccine, 30(42), 6016-6019. PREVENTING THE TRANSMISSION HPV vaccine $8000

LTD, has received prequalification by the World Health Organization (Regan, 2019). The Gardasil 9 vaccine has been approved for use in males and females age 9 through 45 years (Immunize.org, 2022). Catch-up vaccinations – vaccinations given to those who are behind in immunization or who are starting later than the recommended age – are recommended for males and females from ages 27-25 if they are at increased risk of HPV infection (Mayo Clinic, 2022). The vaccine may also be administered to men ages 22 through 26 who have not completed the 3-dose series. If the vaccine is given before exposure to the types of HPV virus covered by the vaccine, females are protected from most cases of cervical cancer, as well as vaginal and vulvar cancers. The vaccine protects both males and females from genital warts and anal cancer (Mayo Clinic, 2022; U.S. Food and Drug Administration, 2020). However, the vaccine does not obviate the need for sexually active individuals to engage in safe sex practices. Table 9 provides information on each of the FDA/CDC-approved HPV vaccines. A two- dose schedule of the HPV Vaccine at time “0” and 6-12 months is for those vaccinated at 9-14 years of age and a three-dose schedule is for those aged 15-45 years of age at time “0” 1-2 months and six months (CDC, 2021j). A minimum of 5 months between doses for the two- dose schedule and 4 weeks between the first and second dose and 6 months after the first dose for the three-dose schedule (CDC, 2021k).

In 1999, the CDC named vaccinations one of the 10 greatest public health achievements of the 20th century (Quirk, 2019). The FDA initially approved the HPV vaccine for females in 2006; the HPV vaccine became available for boys and men in 2009 (Kaiser Family Foundation, 2021; John Hopkins Medicine, 2018; Fisher, 2021).These vaccines provide protection against new HPV infections, but they cannot treat established HPV infections (CDC, 2021c). To be effective, they must be administered prior to HPV exposure. The vaccine provides the greatest protection when it is administered before any sexual contact has occurred. The FDA therefore recommends that the HPV vaccine be administered to girls and boys 11 to 12 years of age. However, at a physician’s discretion the vaccine can be given as early as 9 years of age. The vaccine is delivered via a series of 3 injections over a period of 6 months. Duration of protection conferred has not yet been determined. However, studies following vaccinated individuals for 10 years suggest no evidence of weakened protection over time (CDC, 2021e; CDC, 2021f; NCI, 2020). Currently, Gardasil 9 (9vHPV, by Merck®) is the only HPV vaccine which is being distributed in the United States (Immunize.org, 2022). In December of 2014, the FDA approved Gardasil 9 for use in the prevention of diseases caused by nine HPV types (U.S. Food and Drug Administration, 2018; Immunize.org, 2022). An HPV new vaccine, Cecloin® by Xiamen Innovax Biotech, Co.,

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