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HPV Vaccine

When evaluating the costs of vaccination with the Merck product, Gardasil™, here are the facts which must be considered in relation to costs.  The risks of the vaccine itself are more difficult to evaluate and will only be known after many years.

In this follow-up study of vaccinated women, the first reference quoted below, there were 755 women who received the vaccine and 750 women, in the placebo group, who did not receive the vaccine. 

In the placebo group, 111 developed persistent HPV16 infection, and 12 of those developed HPV16-related CIN2-3. 

In the vaccine group, 7 developed persistent HPV16 infection, and none developed HPV16-related CIN. At an average cost of $400 for the vaccine, the cost to vaccinate the “vaccine group” was $400 x 755 = $320,000. 

Therefore, it cost $320,000 to prevent CIN2-3 in 12 women (based on the incidence in the placebo group), or, about $25,000 per CIN2-3 infection. Compare this with the cost of treating 12 women with some alternative or traditional therapy, which would have been considerably less per CIN2-3 infection. Actually, the vaccine may be considerably more expensive per infection since the duration of immunity from the vaccine is still unknown; therefore additional immunizations may be required at additional cost. 

In addition, the most effective vaccine (quadrivalent HPV 6/11/16/18 L1 virus-like particle vaccine) is effective against only 4 of the HPV types so this vaccine will not decrease the need (and cost) for annual Pap smear exams. And the vaccine has not been shown to be effective in women already infected with HPV16. However, it has the potential to develop immunity in women against the most troublesome HPV types: 16/18 which are responsible for 70% of cervical cancer, and 6/11 which are responsible for 90% of genital warts. 

The value of the current HPV vaccine should be considered in light of the FDA's and CDC's current suggested recommendations: girls and women 9 to 26 years of age, with the vaccine (Gardasil™ by Merck) administered in three doses at 0, 2, and 6 months. In women 21 years of age or older, a Pap smear evaluation should be done before vaccination. HPV vaccine will not replace the need for other preventative measures such as Pap smears. In women who plan to abstain from sex, or who have only one sexual partner, the risk of HPV 16/18 and 6/11 infection is dramatically reduced and therefore use of the vaccine in such cases is of less value.

JAMA. 2009 Aug 19;302(7):750-7:

Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine.

Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, Izurieta HS, Ball R, Miller N, Braun MM, Markowitz LE, Iskander J.Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Mailstop D-26, Atlanta, GA 30333, USA. bfs9@cdc.gov

Objective: To summarize reports to the Vaccine Adverse Event Reporting System (VAERS) following receipt of qHPV.

Design, setting, and participants: Review and describe adverse events following immunization (AEFIs) reported to VAERS, a national, voluntary, passive surveillance system, from June 1, 2006, through December 31, 2008. Additional analyses were performed for some AEFIs in prelicensure trials, those of unusual severity, or those that had received public attention. Statistical data mining, including proportional reporting ratios (PRRs) and empirical Bayesian geometric mean methods, were used to detect disproportionality in reporting.

Main outcome measures: Numbers of reported AEFIs, reporting rates (reports per 100,000 doses of distributed vaccine or per person-years at risk), and comparisons with expected background rates.

Results: VAERS received 12 424 reports of AEFIs following qHPV distribution, a rate of 53.9 reports per 100,000 doses distributed. A total of 772 reports (6.2% of all reports) described serious AEFIs, including 32 reports of death. The reporting rates per 100,000 qHPV doses distributed were 8.2 for syncope; 7.5 for local site reactions; 6.8 for dizziness; 5.0 for nausea; 4.1 for headache; 3.1 for hypersensitivity reactions; 2.6 for urticaria; 0.2 for venous thromboembolic events, autoimmune disorders, and Guillain-Barré syndrome; 0.1 for anaphylaxis and death; 0.04 for transverse myelitis and pancreatitis; and 0.009 for motor neuron disease. Disproportional reporting of syncope and venous thromboembolic events was noted with data mining methods.

Conclusions: Most of the AEFI rates were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope and venous thromboembolic events. The significance of these findings must be tempered with the limitations (possible underreporting) of a passive reporting system.

Obstet Gynecol 2006 Jan;107(1):18-27:

Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial.

Mao C, Koutsky LA, Ault KA, Wheeler CM, Brown DR, Wiley DJ, Alvarez FB, Bautista OM, Jansen KU, Barr E.   Department of Obstetrics and Gynecology and Epidemiology, University of Washington, Seattle, Washington 98104-2499, USA.  

"Objective: Human papillomavirus (HPV) virus-like particle (VLP) vaccines have demonstrated effectiveness in preventing persistent HPV infections. Whether protection lasts longer than 18 months and, thus, impacts rates of cervical intraepithelial neoplasia (CIN) 2-3 has not yet been established. We present results from an HPV16 L1 VLP vaccine trial through 48 months.  

Methods: A total of 2,391 women, aged 16-23 years, participated in a randomized, double-blind, placebo-controlled trial. Either 40 mug HPV16 L1 VLP vaccine or placebo was given intramuscularly at day 1, month 2, and month 6. Genital samples for HPV16 DNA and Pap tests were obtained at day 1, month 7, and then 6-monthly through month 48. Colposcopy and cervical biopsies were performed if clinically indicated and at study exit. Serum HPV16 antibody titer was measured by radioimmunoassay.  

Results: Among 750 placebo recipients in the per protocol population, 12 women developed HPV16-related CIN2-3 (6 CIN2 and 6 CIN3). Among 755 vaccine recipients, there were no cases (vaccine efficacy 100%, 95% confidence interval [CI] 65-100%). There were 111 cases of persistent HPV16 infection in placebo recipients and 7 cases in vaccine recipients (vaccine efficacy 94%, 95% CI 88-98%). After immunization, HPV16 serum antibody geometric mean titers peaked at month 7 (1,519 milli-Merck units [mMU]/mL), declined through month 18 (202 mMU/mL), and remained relatively stable between month 30 and month 48 (128-150 mMU/mL).  

Conclusion: The vaccine HPV16 L1 VLP provides high-level protection against persistent HPV16 infection and HPV16-related CIN2-3 for at least 3.5 years after immunization. Administration of L1 VLP vaccines targeting HPV16 is likely to reduce risk for cervical cancer."

Gynecol Obstet Fertil 2006 Mar;34(3):189-201.  

Cervical cancer prevention: the impact of HPV vaccination. 

Monsonego J. Institut A.-Fournier, 174, rue de Courcelles, 75017 Paris, France.  

“Cervical cancer remains a critical public health problem that is second only to breast cancer in overall disease burden for women throughout the world. In spite of the success of cervical cancer screening, Pap cytology screening is yet to be effectively implemented or has failed to reduce cervical cancer rates to an appreciable extent.

Screening appears to benefit only a small fraction of women although a much larger percentage endures the inconvenience of the Pap test in order to avoid cervical cancer. The establishment of human papillomavirus (HPV) infection as the necessary cause of cervical pre-cancers and cancers provides a tremendous opportunity for cervical cancer prevention through vaccination.  

HPV 16 and 18 cause 70% of cervical cancers worldwide. Thus a prophylactic vaccine to prevent HPV-related precancerous lesions and cancers would save lives, reduce the need for costly medical procedures and provide both women and communities throughout the world with substantial benefits. Based on the induction of neutralizing antibodies by non-infectious virus-like-particles (VLP) of L1 capside protein, prophylactic HPV vaccines have consistently induced high titer of neutralizing antibodies with minimal side effects and induce more than 90% protection from persistent HPV 16-18 infection and HPV 16 and 18 associated high-grade cervical intraepithelial neoplasia (CIN) in proof-of-concept efficacy trials.  

HPV 16-18 vaccination will prevent HPV16-18 incident infection, and subsequently decrease in 90% the frequency of abnormal Paps attributable to these types and in about 50% overall abnormal Paps. HPV vaccination will reduce the number of women who require colposcopy, biopsy and cervical treatment for precancerous cervical lesions. The level of protection from death due to cervical cancer could exceed 95%.  HPV vaccination targeting young female adolescents, aged 11 to 16 years, with a catch-up of those aged 17-25 years, would be a strategy to be addressed. Cervical cancer screening strategies, that will be cost-effective for the proper surveillance of women protected by HPV vaccination, are under analysis.”

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