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The 2007 Advisory Committee on Immunization Practices'recommendation report on the quadrivalent HPV vaccine [5]summarized the studies evaluating its efficacy and con-cluded that the vaccine has high efficacy in preventingpersistent HPV infection, cervical cancer precursor lesions,vaginal and vulvar cancer precursor lesions, and genitalwarts caused by HPV types 6, 11, 16, or 18 among femaleswho have not already been infected with the respective HPVtype. The report recommended vaccination of females aged1112 years based on several considerations, includingstudies showing high antibody titers achieved after vaccina-tion at that age, and data on HPV epidemiology and age ofsexual debut in the United States. The vaccine has beendemonstrated to provide protection for at least 5 years withno evidence of waning protection. Long-term follow-upstudies are underway to determine duration of protection.The recommendation also considered cost-effectivenessevaluations and the established young adolescent healthcarevisit at age 1112 years recommended by several profes-sional organizations. Therefore, concerns regarding thestudy population are not totally unfounded, as most of the

studies were indeed done on adult women, and the agerecommendation was based mostly on assumptions andconvenience. In addition, basing the age recommendationon the girls' age of sexual debut in the United States is notnecessarily applicable to other countries and cultures.

As for the safety of the vaccine, which some havequestioned, information is available on the Centers forDisease Control and Prevention website [6]. Since May 8,2007, the site has received a total of 1763 reports ofpotential side effects following HPV vaccination, of which 94(5%) are defined as serious. They include 13 unconfirmedreports of GuillainBarr syndrome and 4 deaths: 1 involvinga pulmonary embolism, 1 involving deep venous thrombosis(both in women on birth control pills), and 2 reportedly

caused by influenza unrelated to vaccination. Therefore,none of the 4 deaths appears to be caused by thevaccination. Such reports of serious adverse reactionscause fear among parents who are trying to make thedecision of whether to administer a vaccine to their daughteror not. Obviously, as with any other drug or vaccine, years ofpostmarketing surveillance are required to confirm initialefficacy and safety estimates based on premarketing trials.

Additional issues that have received just as much mediaattention include defining the optimal age for vaccination,vaccination of males, the need for boosters, introduction ofthe vaccine in low-income countries, and the impact ofvaccination on screening programs [7]. Furthermore, the

cost-effectiveness of the HPV vaccine has not been clearlyoutlined. Although the studies suggest that the introductionof the HPV vaccine could be cost-effective in certaincountries [8,9], the key variables regarding its introductionworldwide have not been well addressed. The vaccine isexpensive, and it will be challenging to get it to where it isneeded most to have the most significant impact. However,the facts remain that cervical cancer is the leading cause ofdeath in women in low-income countries and that HPVvaccines are very effective in preventing the infection of the

two most common high-risk HPV genotypes, which cause 70%of all cervical cancer.

FIGO's President, Professor Dorothy Shaw, has highlightedthe major programs and priorities endorsed by FIGO'sExecutive Board [10]. Saving women's lives through fightingcervical cancer was identified as one of the high priorityaction areas for FIGO. With the introduction of the HPVvaccine it is important to develop effective plans thatintegrate immunization with appropriate cervical screeningprograms. Continuing data collection about the efficacy andsafety of the vaccine, educating healthcare providers andthe public, documenting cost-effectiveness, and improvingvaccine deliveryespecially in low-income countriesare allimportant elements for effective strategies toward imple-menting appropriate programs and reducing cervical cancerworldwide.

References

[1] Stobbe M. Ouch! Cervical cancershotspainful. Associated Press;

January 3 2008. http://ap.google.com/article/ALeqM5hhuO4x2Hjvo2Y-NJXxMPQpfpGYRwD8TULMF80 . Accessed January5, 2008.

[2] Stuttaford T, Godson S. Is it time for a cancer jab? The Times;December 29 2000. http://www.timesonline.co.uk/tol/life_and_style/health/our_experts/article3103543.ece. Accessed January5, 2008.

[3] Azariah S. HPV vaccine why are we waiting? New ZealandDoctor Online; December 19 2007. http://www.nzdoctor.co.nz/news?article=6d18bff6-fabf-4bff-91b2-b23d32ca087b . AccessedJanuary 5, 2008.

[4] Mokhtar NA. To vaccinate or not? The Star; December 16 2007.http://thestar.com.my/health/story.asp?file=/2007/12/16/health/19746501&sec=health. Accessed January 5, 2008.

[5] Markowitz LE, Dunne EF, Saraiya M, Lawson H, Chesson H, Unger

ER. Quadrivalent human papillomavirus vaccine: recommenda-tions of the Advisory Committee on Immunization Practices(ACIP). MMWR Recomm Rep 2007;56:124. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm. Accessed Jan-uary 5, 2008.

[6] HPV vaccine questions and answers for the public. Centers forDisease Control and Prevention; June 28 2007. http://www.cdc.gov/vaccines/vpd-vac/hpv/hpv-vacsafe-effic.htm. AccessedJanuary 5, 2008.

[7] Wright TC, Bosch FX, Franco EL, Cuzick J, Schiller JT, GarnettGP, et al. HPV vaccines and screening in the prevention ofcervical cancer. Vaccine 2006;24(Suppl 3):S25161.

[8] Newall AT, Beutels P, Wood JG, Edmunds WJ, MacIntyre CR.Cost-effectiveness analyses of human papillomavirus vaccination.Lancet Infect Dis 2007;7:28996.

[9] Kulasingam S, Connelly L, Conway E, Hocking JS, Myers E, ReganDG, et al. A cost-effectiveness analysis of adding a humanpapillomavirus vaccine to the Australian National CervicalCancer Screening Program. Sex Health 2007;4:16575.

[10] Shaw D. A vision for FIGO. Int J Gynecol Obstet 2007;97:825.

Maya Hammoud

Weill Cornell Medical College, Qatar

E-mail address: mmh2004@qatar-med.cornell.edu.

124 SPECIAL EDITORIAL

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