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QUADRIVALENT HPV VACCINE GARDASIL

VIEWS: 22 PAGES: 33

									  Ontario’s HPV Immunisation Programme



         What Went Wrong?
           CPHA Annual Conference
                2 June 2008
                 Dr. Ian Gemmill
              Medical Officer of Health
Kingston, Frontenac and Lennox & Addington Public Health
               OUTLINE

 HPV & its consequences
 HPV vaccine
 Description of Ontario’s programme
 Negative publicity about HPV vaccine
 Lessons learned
                                                                                      The virus



                              Human papillomavirus
                                                                HPV is one of several
                                                                 species of the genus
                                                                 Papillomavirus in the
                                                                 Papovaviridae family
                                                                There are more than
                                                                 200 types of HPV
                                                                HPV is a relatively small
                                                                 virus containing two
                                                                 strands of DNA within a
                                                                 spherical shell (capsid)

                   HPV capsids,
           approximately 55 nm in diameter

Image source: Dr Linda Stannard, UCT/Science Photo Library
                                                                                   The virus

                            Natural history of HPV
                                  infection
                                           HPV infection



               6, 11, other                                   16, 18, other
             low-risk types                                  high-risk types


               Anogenital                             Transient         Persistent
                 warts                                infection         infection
                                                           CIN I/CIN II  CIN II/CIN III

Regression                          Therapy
                                                                           Cancer

                                                           Regression
CIN = cervical intraepithelial neoplasia
       A remarkably strong association
        RR
           in cancer epidemiology
         > 500             HPV 18 and cervical adenocarcinoma in the Philippines
                                       HPV 16 and cervical cancer in Costa Rica
                                            HPV and cervical cancer in Bangkok
           100                        Hepatitis B virus and liver cancer in Taiwan
            50                       Hepatitis B virus and liver cancer in Greece
            20                          Hepatitis C virus and liver cancer in Italy
            10                               Cigarette smoking and lung cancer
 1
                                                  NEUTRAL REFERENCE LINE
            0.1                  Smoking cessation (< 50 years) and lung cancer
            0.6                  Adult HBV vaccination and liver cancer in Korea
            0.1              Newborn HBV vaccination and liver cancer in Taiwan
Bosch FX et al. J Clin Pathol 2002; 55: 244–65.
                             HUMAN PAPILLOMA VIRUS &
                                CERVICAL CANCER


            Cervical Cancer: Incidence and Mortality per 100,000 Females, Canada, 1990-1995

Prepared by: Division of STD Prevention and Control, Bureau of HIV/AIDS and STD, LCDC, Health Canada, 1997




                                                                  DR. I. M. GEMMILL, MD, CCFP, FRCPC
QUADRIVALENT HPV
   VACCINE:
  GARDASIL™
                             HPV VACCINE
An excellent vaccine that promises to decrease HPV cancers
dramatically

Immunogenicity:               ~100% seroconversion
Efficacy:                     nearly 100% type specific efficacy
                               protects against infection and CIN2
Safety:                       side effects are mild and short-lived
                               fewer reactions than with placebo
Duration of   protection:     unknown but at least 5 years
                               Antibody decay curve looks
                               promising
                               ? 10 years to lifelong
Cross-reactivity:              HPV 45 & possibly HPV 31

                                          DR. I. M. GEMMILL, MD, CCFP, FRCPC
  National Advisory Committee on Immunization
     Recommendations for HPV Vaccine

1. Females between 9 and 13
2. Females between the ages of 14 and 26,
  even if they are already sexually active or have had HPV
  infection or its consequences
3. No recommendations can be made for
  females >26 years of age although its use
  can be considered in individual
  circumstances
                                   CCDR. February 15, 2007; 33(ACS-2):1-32.
          What Will this Vaccination
            Prevent in Women?

 Up  to 70% of all cervical cancers
 About 90% of genital warts
 A large proportion of vulvar, anal and oral
  cancers
 Precancerous lesions:
     Cervical
     Vaginal
     Vulvar
 Hon. Jim Flaherty
Ministre de Finance
    Honourable Dalton McGuinty
        Premier of Ontario




MCGUINTY GOVERNMENT LAUNCHES
  LIFE-SAVING HPV IMMUNIZATION
            PROGRAM
The programme:

 announced  on the 2 of August 2007 by
  premier McGuinty, one month before the
  beginning of the 2007 provincial election
  campaign
 targets Grade 8 girls (13 to 14 years)
 administered in schools
 administered   by local public health
  agencies
 scheduled to begin just weeks after the
  announcement (1st September in Toronto,
  because of the large population)
 during the same period, public health runs
  both universal influenza and HBV vaccine
  programmes
  Canadian Medical Association Journal
            28 August 2007


‘Human papillomavirus, vaccines and
  women's health: questions and
  cautions’

Abby Lippman PhD, Ryan Melnychuk
 PhD, Carolyn Shimmin BJ, Madeline
 Boscoe inf. DU
     Maclean’s Magazine
 CATHY GULLI, 27 August 2007
‘Our girls are not guinea pigs’

‘Is an upcoming mass inoculation of a generation
   unnecessary and potentially dangerous?’

‘Maclean's cover story re-ignites Gardasil debate’

‘Canada's top doctor expresses concern’
C
  ‘Showdown in Texas over HPV
         vaccine order’
AUSTIN, Texas (AP) — Texas lawmakers rejected Gov.
  Rick Perry's anti-cancer vaccine order Wednesday,
  sending him a bill that blocks state officials from
  requiring the shots for at least four years.

Perry has said he is disappointed but has not indicated
  whether he will veto the bill. He has 10 days to sign or
  veto it, or the proposal will become law without his
  signature.

Lawmakers can override a veto with a two-thirds vote of
  both chambers. The legislation passed by well over that
  margin in both chambers.
         Progress of the Programme

   the programme is mostly complete for 2007-
    2008
   only 50% of eligible girls have accepted the
    vaccine
   in some schools, none has been immunised
   some teachers have discouraged girls not to
    take the vaccine
   in some schools, girls who received the vaccine
    were ridiculed by their peers.
             What went wrong?
 negative  publicity almost undoubtedly has
  contributed to the low uptake
 a significant proportion of girls, their
  parents or both appear to have lost
  confidence in the vaccine
 This reaction is completely different than
  the experience with HBV vaccine in the
  1990’s, when complaints were from
  parents whose children were not eligible
  for the vaccine
           What went wrong?
 The   large impact of the negative publicity
  was not anticipated by public health
  officials
 There were some who advised not taking
  action to avoid giving credibility to the
  negative publicity
 Others underestimated the impact or did
  not have time to get enough information
  out
 Some Measures that Were Taken
The Government of Ontario:
 The Ministry monitored the co-operation of
  school boards
 It provided web information and fact sheets
 a new media campaign has since been
  launched

The Council of Ontario Medical Officers of Health
 Letters to both Maclean’s and to the CMAJ
 Some Measures that Were Taken
 Local   action:
     press conference
     letter from the MOH to girls & their parents
     increased information on HPV & the vaccine
     questions answered by telephone and at
      clinics
     support for the programme was solicited from
      other health professionals
          Lessons Learned

 Pay  attention to negative and untruthful
  stories in the media
 Do not underestimate the potential power
  and effect of the media to influence the
  public
 Respond quickly and forcefully to counter
  mistruths or misinformation that is
  promulgated about vaccines
             Lessons Learned
 The  public can quickly become mistrustful
  of a vaccine
 People are prepared to believe mistruths
  about vaccine
 Ensure that populations that are targeted
  for vaccine receive lots of information that
  is:
     simple & clear
     timely, accessible & plentiful
                 Next Steps
        needs to reconsider its HPV
 Ontario
 programme:
     extend eligibility of Grade 8 girls who have
      turned down the vaccine this year
     extend the programme to all female high
      school
     consider providing the vaccine to boys
     consider providing the vaccine to women out
      of high school
                  Next Steps
 Need  to assess what factors were more
  important in parents’ decisions
 Ontario needs to promote its HPV
  programme better:
     more prominence of media ads
     better communication to students & parents
     timely provision of materials to local public
      health agencies
THANK YOU.

QUESTIONS?

								
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