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HPV Vaccine: Signature Project. Roshan Bastani, PhD & Jennifer Allen, PhD National CPCRN Meeting Boston, MA Nov 1-2, 2007. Licensed & Candidate Prophylactic HPV Vaccines. GARDASIL Efficacy. Per-protocol Efficacy (98-100%) Efficacy in reducing HPV 6,11,16,18 related disease in unexposed
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HPV Vaccine: Signature Project Roshan Bastani, PhD & Jennifer Allen, PhD National CPCRN Meeting Boston, MA Nov 1-2, 2007
GARDASIL Efficacy • Per-protocol Efficacy (98-100%) • Efficacy in reducing HPV 6,11,16,18 related disease in unexposed • Intent-to-treat Efficacy (44-73%) • Impact in reducing disease from HPV 6,11,16,18 in all those vaccinated • General Population Impact (17-34%) • Impact in reducing all disease (regardless of HPV type)
Remaining Unanswered Questions • Long term safety • Extent of immunity • Cross protection vs. type replacement • Pre/post sexual debut • Male vaccination • Impact on cervical cancer deaths will not be apparent for long time • Comparison to other HPV vaccines
Attitudes and Knowledge • General lack of knowledge about HPV • Low perception of risk • Mistrust of vaccine • Both are likely to impair demand for vaccine • Will require public educational efforts to raise awareness • Implementation of policy and other interventions to increase utilization Dempsey et al, Am Jour of Mgd Care, 2006 Dec; 12(17 Suppl)
Challenges with Adolescent Vaccination • Adolescents less likely to seek care • No established preventive care visits • Acute/emergent care • Physicals for school/athletics • More likely to be uninsured Dempsey et al, Am Jour of Mgd Care, 2006 Dec; 12(17 Suppl)
Gardasil Costs • Most expensive recommended vaccine introduced to date • $120/dose private • $96.75/dose public • Has complicated already strained vaccine financing system
Federal Contract Prices for Vaccines Recommended Universally for Children and Adolescents 1985, 1995, 2006 $1185 $894 $155 $45 Federal contract price shown for 1985 and 1995 are averages that account for price changes within that year. Source: Anne Schuchat, CDC
Vaccine Financing • Vaccines for Children (VFC) Program • Federal “317” funding • State funding • Private funding • Manufacturer assistance programs
Current NCI Portfolio • About 8 currently funded projects, R15, R01, R03, R21, R43/44 • KAB Surveys: parents, women, physicians • Decision making re: vaccinating girls among parents • Dev low literacy audio-visual materials for parents • F/U of abnormals • Feasibility and efficacy of self-sampling vs in clinic sample
Possible CPCRN Projects • Compile existing instruments, develop a minimal set of standard items • Gather existing education/intervention materials and protocols • Conduct surveys: physicians, parents, youth, college, adults • Develop decision tools: providers, parents, women • Conduct interventions across sites: • policy: access, coverage, mandates • organizational level, individual level, provider, women • Technical assistance to CBOs
QuestionsPeople Have • Will GARDASIL help if already have HPV? • Does one still have to get PAP Tests if vaccinate? • Who is going to pay for the vaccine? How much does it cost? • What are the benefits and harms of the vaccine? • How long do the benefits and harms last?
QuestionsPeople Have • Why should my daughter be vaccinated at age 11 or 12? She's not sexually active. Can't we wait? • Does the vaccine send a message that it's okay to have sex and therefore encourage or lead to increased sexual activity?
What do parents really think? • Unfamiliar with HPV • “I’ve never heard of it. I’ve heard of syphilis, gonorrhea. I’ve heard of genital warts, I’ve heard of herpes. Are any of these considered in the HPV family?”* • Information sheet-- changed knowledge, but not acceptability of HPV vaccine** • Risk of acquiring HPV • “This is somewhat different vaccine than tetanus and chickenpox… HPV is preventable by not having sex, not being promiscuous.”* • Age of HPV vaccine administration • Greater vaccine acceptability at older age groups** * Olshen, et. al., 2005 ** Dempsey, et al. 2006