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Women’s health

Article

Challenges, lessons learned and results following the implementation of a human papilloma virus school vaccination program in South Australia Maureen Watson, Douglas Shaw, Luda Molchanoff and Cathy McInnes Communicable Disease Control Branch Department of Health South Australia

G

ardasil is a quadrivalent vaccine indicated in females aged 9 through to 26 years for the prevention of cervical, vulvar, and vaginal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by HPV Types 6, 11, 16, and 18 (which are included in the vaccine).1 On 29 November 2006 the Australian Government announced that HPV vaccine would be funded for girls aged 12 to 26 years through a three-tiered program commencing in April 2007. • 12-13 year olds would receive the HPV vaccine through an annual program delivered through schools. • 13-18 year olds would receive the HPV vaccine through a catch-up program delivered through schools over a period of two years • Females aged 16-18 years not at school and 18-26 year olds would be able to access the vaccine through general practices and other community providers. The announcement left only four months (including the Christmas school holiday period) to prepare for implementation of both the annual program and the catch-up program.

Planning The short time frame created several pressing issues including the development of vaccine purchasing contracts, service delivery plans, consent forms, provider and community education and communication materials.

The number of students to be offered three doses of HPV vaccine in South Australia in 2007 was 50,191 in Years 8 to 12 across 219 high schools. An ongoing and extensive catch-up program including multiple visits to schools and the recording of large amounts of data had to be designed, co-ordinated and implemented to integrate with the existing school immunisation program. The data would be collected using existing data collection processes and submitted to the Immunisation Section for collation.

Setting the dates for school visits South Australia has been delivering a coordinated immunisation program through schools for almost a decade. The program is co-ordinated by the Department of Health and delivered through contractual arrangements with local government. In 2007, it was planned to deliver a two dose Hepatitis B (Hep B) vaccine catch-up program, a Varicella vaccine (VZV) catch-up program and a booster dose of diphtheria, tetanus and adult pertussis (dTpa) vaccine. This was to be offered over two school visits to all Year 8 students, with first dose of Hep B vaccine and VZV offered at the first visit and the second dose of Hep B vaccine and dTpa vaccine offered at the second visit. The 2007 dates for visiting schools were already set. With this school immunisation program already in place, incorporating a 3-dose HPV vaccine was problematic given the HPV program could not commence before

Abstract Objective: To describe the process and challenges in the roll out of a large cervical cancer vaccination program to protect against human papilloma virus (HPV) infection. Methods: This article describes the process of planning and implementing a HPV vaccination program using the existing state-wide framework that supports vaccine delivery to all 219 high schools in South Australia. The decision was made to offer three doses of HPV vaccine to 50,191 female students in Years 8-12 during the 2007 school year. Results: By November 2007, despite many challenges, the school vaccination program had delivered 107,541 doses of HPV vaccine. Coverage of dose 1 was highest in Years 8 (83%) and 10 (70%), but was reduced for doses 2 and 3 in all year levels, with dose 3 coverage ranging from 55% (Year 11) to 77% (Year 8). Conclusions: The introduction of a large school-based vaccination program at short notice posed new challenges for the co-ordination and implementation. Not all schools supported the introduction of HPV vaccine, resulting in reduced access for some students. Negative media messages provided a strong platform for individuals who opposed vaccination. These factors may have contributed to the less-thanexpected uptake of HPV vaccine. Implications: Historically, there has been high uptake of other vaccines given to adolescents. However, the introduction of HPV vaccine may have adversely affected the uptake of Hepatitis B vaccine, given concurrently in the school program. Further studies are needed to determine if this is likely to have a negative effect on the public perception of the value of vaccine programs in general.

Submitted: December 2008

Revision requested: March 2009

Accepted: April 2009

Correspondence to: Maureen Watson, Immunisation Section, Communicable Disease Control Branch, PO Box 6, Rundle Mall, Adelaide, SA 5000. Fax: (08) 8226 7197; e-mail: [email protected]

Key words: Papilloma virus vaccines, schools, South Australia. Aust N Z Public Health. 2009; 33:365-70 doi: 10.1111/j.1753-6405.2009.00409.x

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AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH © 2009 The Authors. Journal Compilation © 2009 Public Health Association of Australia

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April 2007. In addition, two weeks in April were unavailable due to the Easter holidays. The duration for delivery of HPV vaccine in schools throughout 2007 was confined to the period between May and late November. The recommended schedule for HPV vaccine is 0, two and six months. Since it was impossible to deliver the recommended schedule in schools within the timeframe available, an agreement was reached with the Australian Technical Advisory Group on Immunisation (ATAGI) to deliver the 2007 program using an accelerated schedule of 0, 1 and 4 months. An advisory group comprising representatives from the education sector, local councils, Divisions of General Practice and the Department of Health provided guidance and advice around the implementation of the 2007 school program, but could not meet until early 2007 due to the Christmas holidays. The collaboration between these representatives led to the establishment of new dates for three visits to all schools to offer HPV, VZV and Hep B vaccines. The delivery of dTpa had to be moved to Year 9 and withheld in 2007.

Implementation The advisory group explored ways of implementing both the annual program and the catch-up program. A decision was reached to include HPV vaccine in the annual program for all Year 8 girls along with Hep B vaccine and VZV to all Year 8 students over three visits. In addition, rather than deliver the HPV vaccine catch-up program over two years, the program would be offered to girls in all other year levels at the same three visits in each school. This would ensure the older adolescents in Years 10, 11 and 12 would be offered the vaccine prior to leaving school and the younger Year 8 and 9 girls would receive the vaccine within the optimal age range (Table 1).

Lessons learned Sensitivity of information Education and communication was necessary to convey the key messages around burden of disease, vaccine efficacy and potential side-effects to alleviate community concerns. These included suggestions from some community groups that the vaccine would encourage promiscuity in young girls. There were specific communication requirements for some religious groups and schools. It was agreed that the key messages needed to focus more on the community benefit from the reduction in cervical cancer rates with less focus on the reduction of sexually transmitted diseases (e.g. genital warts). The education sector provided feedback that the information relating to HPV contained references to sex and sexually transmitted infections. Some schools considered this information to be sensitive and requested the information brochures and consent forms for HPV vaccine be in a sealed envelope. It was agreed that this could be easily achieved if used only for HPV

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information. Hep B, varicella and dTpa information would continue to be distributed as before.

Schools rejecting the HPV vaccination program Two Christian schools in Adelaide refused to allow immunisation providers to include HPV vaccine in their vaccination program as they felt this may encourage early sexual promiscuity. The schools were advised they had an obligation to permit the distribution of information to allow parents to make an informed choice regarding HPV vaccination. Girls wanting to receive HPV vaccine were advised to attend a local council clinic held outside of the school.

Vaccine supply Accessing sufficient supplies of HPV vaccine was a national issue given the size of the catch-up program. The National Immunisation Committee (NIC), which oversees the implementation of the National Immunisation Program (NIP) in Australia, agreed that the catch-up program be staggered and the General Practice component (women 16-26 years, not in school) not commence until July 2007. This enabled initial vaccine supplies to be directed to the school programs. Supplies of Gardasil were available in packs of 10 vials, however approximately 110,000 doses were available nationally in pre-filled syringes, but only in single packaging. The ease of administration using prefilled syringes was offset by the bulky packaging of each individual vaccine. SA required approximately 130,000 doses in 2007 and it was agreed to purchase all the pre-filled syringes if available. South Australia was allocated the entire supply of prefilled syringes.

Co-administration risks On receiving a sample of Gardasil it was noted that the plunger was green. The plunger of Hep B vaccine to be delivered to Year 8 girls at the same time as Gardasil was also green, albeit a different shade. To reduce the risk of a provider inadvertently vaccinating an individual twice using the same vaccine, an alert was sent to all providers with a photograph of the two vaccines.

Anti Vaccination Activity On 2 April 2007, a South Australian community group committed to informing the public about the dangers associated with vaccines reported on their website – HPV Vaccine Alert – “Anyone with a HPV infection (and they are common), Table 1: Vaccines to be delivered through school immunisation program in 2007 and 2008. School visit 2007 Year 8 2007 Catch-up 2008 Yr 8 All Girls only Yrs 9, 10,11 (as for 2007) +12 girls only plus all year 9 Visit 1 Visit 2 Visit 3

Hep B (1) HPV (1) VZV HPV (2) Hep B (2) HPV (3)

HPV (1) HPV (2) HPV (3)


dTpa

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who is given the vaccine risks immune system shutdown or autoimmune disease.” They also claimed HPV vaccine causes HPV infection, cervical cancer, birth defects, miscarriages and infertility.2 This information spread quickly through the schools and presented difficulties for school immunisation providers in responding to these claims. A question and answer sheet was prepared by the National Centre for Immunisation Research and Surveillance (NCIRS) that addressed HPV vaccine efficacy and safety.3 The information sheet also briefly described the position taken by those opposed to vaccination and how some of their views are sensationalised by the media.

Reporting of Adverse Events Following Immunisation (AEFI) In May 2007, ABC News reported that some girls at a southeast Melbourne school fell ill after being vaccinated.4 Sacred Heart Girls College in Oakleigh reported that 26 girls fell sick with some taken to hospital after being vaccinated. The ABC report stated “Victorian health authorities will investigate possible reactions to the cervical cancer vaccine, Gardasil”. The Victorian Department of Human Services arranged to offer the affected girls follow-up vaccination through the adverse events clinic at the Royal Children’s Hospital in Melbourne. This situation led to discussions with the NIC and the Therapeutic Goods Administration (TGA) and it was agreed that all reports of adverse events following administration of Gardasil were to be reported and reviewed by Adverse Drug Reaction Advisory Committee (ADRAC) and monitored by the TGA. While continuing to monitor the situation, the TGA declared there was no reason to consider any changes to the recommendations for Gardasil.5 It has since been suggested that the situation with these girls was a case of mass psychogenic illness.6 When vaccines are administered to groups, the physical reactions of the recipients may be similar, causing a form of mass reaction. This has been defined as a collective occurrence of symptoms suggestive of organic illness but without an identified cause in a group of people with shared beliefs about their symptoms.

FigureFigure 1: 2007 HPV coverage 8-12 South Australia.a 1 2007 HPV Coverage Yrs 8yrs - 12 South Australia* 100% Dose 1

90%

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Media reports continued to circulate information about the number of adverse events reported following the administration of Gardasil. On 25 May 2007, The Age newspaper in Melbourne reported with a headline asking “Why are we experimenting with drugs on girls?”7 The article provided readers with information from the US anti-vaccination lobbyist webpage. In addition, a number of internet pages claimed there were increasing deaths resulting from administration of Gardasil.8,9 In December 2007, ABC News reported “Researchers play down claimed Gardasil vaccination risk”.10 The same month, the current affairs program Today Tonight presented information on two girls who described unusual reactions that they claimed were the result of receiving Gardasil. A spokesperson from the anti-vaccination group, declared “the research behind Gardasil is too flimsy”.11

Uptake of HPV vaccine At the beginning of the school year, enrolment figures were obtained from the education sector. As part of the contractual arrangements for service delivery with local councils, providers submitted data on the number of consent forms distributed, the number consenting to vaccination, the number vaccinated on the day, the number previously vaccinated and the number who declined vaccination. This was collected by dose number, school and by Year level and entered into a database which was cleaned and analysed by the Immunisation Section. The 2007 school vaccination program was completed by the end of November 2007 with a total of 107,541 doses of Gardasil distributed. Figure 1 shows HPV vaccine coverage rates by dose number and by year level. Coverage of dose 1 was highest in Years 8 (83%) and 10 (70%) and slightly less in Years 11 (64%) and 12 (66%). Coverage was reduced for doses 2 and 3 in all year levels with dose 3 coverage ranging from 55% (Year 11) to 77% (Year 8). The lower than expected results have identified the need for further qualitative studies to explore what factors inhibit or promote uptake. These studies are outside the scope of this descriptive report but planning is under way to conduct focus group discussions with key groups, including female students and their parents. Figure 2: Hepatitis B vaccine coverage year 8 students Figure 2 Hepatitis b vaccine coverage Year 8 students South Australia by year South Australia by year.

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Note: a) A small number of schools are excluded as their data remains incomplete.

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*a small number of schools are excluded as their data remains incomplete.

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Uptake of Hepatitis B vaccine

Reported adverse events following immunisation in South Australia

The total coverage rate for girls and boys fully immunised with two doses of Hep B vaccine in the school program in 2007 was 69% (Figure 2). This is a significant decrease from previous years where total coverage was in excess of 80%. Data collected in 2007 did not include gender. Once the trend towards lower Hep B vaccination was noted, gender-disaggregated data were obtained retrospectively. Based on the available gender disaggregated data, Hep B coverage (2 doses) for Year 8 girls in 2007 was 73% compared to 67% for boys. As gender disaggregated data from previous years is not available it is not possible to determine if there has been any difference in coverage by gender that can be attributed to the introduction of HPV vaccine. Further studies are needed to determine if the lower uptake of Hep B vaccine is related to inclusion of HPV vaccine for this Year level.

F ig u re 3

The South Australian adverse event reporting system received a total of 144 reports relating to HPV vaccine during the period 1 April to 31 December 2007. Vaccines delivered through the school program accounted for 118 (82%) reports, while 26 (18%) reports were from vaccines delivered through the General Practice program. There was one report of urticarial rash, chest tightness and wheeze that met the Brighton Definition of anaphylaxis12 in a 14-year-old girl. Figure 3 shows that of the total reports received, 85 (59%) related to dose 1, 40 (28%) related to dose 2 and 19 (13%) related to dose 3. Of these, 121(84%) reports related to Gardasil only and 19 reports (13%) related to co-administration of Gardasil and Hepatitis B vaccine. There were three reports where Varicella vaccine was co-administered and one report where both Varicella and Hepatitis B vaccines were co-administered.

AE F I fo llo w in g G a rd a s il b y d o s e n u m b e r S o u th Au s tra lia 2 0 0 7

Figure 3: AEFI following Gardasil by dose number South Australia 2007.

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Figure 4: AEFI reported by reaction type and dose in girls 12-18 years following Gardasil 2007.

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The reactions reported following immunisation of HPV vaccine in girls 12 to18 years in 2007 in South Australia are displayed in Figure 4. Some reports included more than one reaction type so the total number of reactions reported (290 reactions) is greater than the total number of reports received (118). These reports (marked Other* in Figure 4) include dizziness, slurring of words, numbness of limbs, amenorrhea, urinary tract infection, cough, drowsiness, flu-like symptoms, itch, seizure, neck stiffness, sore throat and hyporesponsiveness. The most commonly reported reactions were nausea 57 (20%), headache 43 (15%), injection site reaction 27 (9%), fever 22 (8%) and rash 22 (8%), which is consistent with the published Product Information. All unusual AEFI reports following HPV vaccination were offered appointments through the Specialist Immunisation Service (SIS) clinics, with 17 girls reviewed at the Women’s and Children’s Hospital (WCH) and four girls reviewed at Flinders Medical Centre. Of the 17 girls seen at the WCH, 10 were revaccinated with HPV vaccine in the clinic, four chose to visit their GP for re-vaccination, one was admitted for re-vaccination and two declined further vaccination. Seven girls participated in skin testing with six being re-vaccinated, including the one who met the case definition for anaphylaxis.

Discussion Once Governments announce the introduction of a new vaccine into the funded schedule the expectations of the community become set. Sufficient lead time is essential for the planning and development of necessary resources and the acquisition of sufficient vaccine supply. A consultative and collaborative approach with key stakeholders involved is necessary to ensure the disruption to schools is managed appropriately and good working relationships are maintained. Technologies, such as mobile phones and the Internet, together with the media, play an important role in the rapid dissemination of information emerging from very small numbers of individuals. This can have a profound impact on community support for vaccination programs. Claims from a small number of girls about possible reactions to the vaccine drew widespread media attention, providing a powerful vehicle for those who oppose vaccination. These negative messages about the vaccine can give rise to a process termed ‘technological stigma’, the tainting of products or places as dangerous due to associated fears about health.13 The anti-immunisation lobby first posted their concerns just prior to the launch of the HPV vaccination program in April 2007.2 This was followed by negative reports in mainstream media from late May, after delivery of the first dose.4,7 The second dose was offered in July and August with a decline in uptake which was maintained with dose 3. A third negative media report was aired in December 2007 after the program had been completed.10,11 When introducing a new vaccine there is greater scrutiny and less tolerance of adverse reactions compared to other pharmaceutical 2009 vol. 33 no. 4

products. It is important that the public are aware of the systems that inform policy makers and health professionals about the safety of vaccines. Immunisation providers need to be well-informed and prepared for public questioning of the safety profile of any new vaccine. Following a number of reports of suspected anaphylaxis following receipt of Gardasil, a NSW study concluded that the rate of anaphylaxis remained low.14 Providers and individuals should be encouraged to report any serious reaction as there is a continued need for post-marketing surveillance because limited data are available on the long-term safety profile of Gardasil. Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm and urticaria have been added to the Product Information post-marketing reports for Gardasil.1 Program co-ordinators also need to consider how accurate vaccine safety information can be regularly communicated to the community. It is not clear why there has been a decline in the uptake of dose 2 and 3 of HPV vaccine in 2007 which leaves a large number of girls in South Australia only partially protected. Further examination of the data is required to determine if the decline is associated with school type or other socio-economic variables. Although the effectiveness of Gardasil has been demonstrated in preventing the acquisition of HPV infection in females not previously exposed to HPV, it may be less effective in those with prior exposure. Combined with an incomplete course of vaccination (less than 3 doses), this may contribute to further decreased vaccine effectiveness with some women incorrectly believing they are protected. It remains to be seen if these girls will receive their third dose of HPV vaccine. The decrease in the coverage of those fully immunised with hepatitis B vaccine is of concern and raises the possibility that the negativity attached to the HPV vaccine in schools has adversely impacted on the public’s perception of other school program vaccines. In Canada and Spain there have been concerns raised from women’s health advocates about the development and implementation of policies affecting women’s health and how quick fixes proposed to protect women’s health, such as diethylstilbestrol for ‘recurrent’ miscarriages and hormone replacement therapy for menopause related cardiac conditions, have actually turned out to have harmful effects.15 Further concerns have been raised in Canada about the lack of evidence to support the introduction of a universal HPV vaccine program aimed at girls and women.16 The lower than expected vaccine coverage rates for HPV and Hepatitis B vaccine in South Australia also raises the question of whether the rapid introduction and the magnitude of new vaccine programs fosters an air of suspicion and distrust of vaccination policies.

References 1. Merck Sharp & Dohme. Gardasil [product information page on the Internet]. Sydney (AUST): healthlinks.net; 2008 [cited 2008 Sept 3]. Available from: http://secure.healthlinks.net.au/content/csl/pi.cfm?product=cspgarda20308 2. Vaccination Information Servicing Australia [homepage on the Internet]. Adelaide (AUST): VISA; [cited 2008 Oct 17]. Cervical Cancer Vaccine Alert [flyer]. Available from: http://www.visainfo.org.au/


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3. National Centre for Immunisation Research and Surveillance. Human Papillomavirus Vaccines for Australians: Information for GPs and Immunisation Providers [monograph on the Internet]. Sydney (AUST): University of Sydney; 2007 [cited 2008 Oct 23]. Available from: http://www.ncirs.usyd.edu.au/facts/ hpv_jan_2007.pdf 4. ABC News On-line [homepage on the Internet]. Sydney (AUST): Australian Broadcasting Commission; 2007 [cited 208 Sept 28]. Authorities to Investigate Gardasil Reactions. Available from: http://www.abc.net.au/news/ newsitems/200705/s1929773.htm 5. Therapeutic Goods Administration [homepage on the Internet]. Canberra (AUST): Commonwealth Department of Health and Ageing; 2008 [cited 2008 Oct 23]. Human Papillomavirus Vaccine (Gardasil): Advice from the Therapeutic Goods Administration. Available from: http://www.tga.gov.au/ alerts/medicines/gardasil.htm 6. Clements CJ. GardasilTM and mass psychogenic illness [letter]. Aust N Z J Public Health. 2007;31:387. 7. The Age [homepage on the Internet]. Melbourne (AUST): The Age Company Limited; 2007 May 25 [cited 2008 Sept 20]. Why are We Experimenting with Drugs on Girls. Available from: http://www.theage.com.au/news/opinion/whyare-we-experimenting-with-drugs-on-girls/2007/05/24/1179601570922.html 8. WorldNetDaily.com [homepage on the Internet]. Washington (DC): WND; 2007 October 6 [cited 2008 Sept 28]. 8 More Deaths Connected to HPV Vaccine: Adverse Reactions from Gardasil Number in Thousands. Available from: http://www.worldnetdaily.com/news/article.asp?ARTICLE_ID=58004 9. Naturalnews.com [homepage on the Internet]. Taipei (TWN): Truth Publishing International; 2007 October 19 [cited 2009 Sept 28]. 8 More Deaths Caused by Gardasil Bringing Total Number to 11. Available from: http://www.naturalnews. com/022140.html

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10. ABC News On-line [homepage on the Internet]. Sydney (AUST): Australian Broadcasting Commission; 2007 December 3 [cited 2008 Sept 28]. Researchers Play Down Claimed Gardasil Vaccination Risk. Available from: http://www. abc.net.au/news/stories/2007/12/03/2108379.htm 11. Todaytonight. [homepage on the Internet]. Melbourne (AUST): Yahoo! 7 News; 2007 December 7 [cited 2008 Sept 3]. Gardasil Side Effects. Available from: http://au.todaytonight.yahoo.com/article/43654/health/gardasil-effectscontroversy 12. Rüggeberg JU, Gold MS, Bayas JM, Blum MD, Bonhoeffer J, Friedlander S, et al. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5675-84. 13. Satterfield TA. Risk Remediation and the Stigma of a Technological Accident in an African American Community. Human Ecology Review. 2000;7(1):1-11. 14. Brotherton JML, Gold MS, Kemp AS, McIntyre PB, Burgess MA, CampbellLloyd S. Anaphylaxis following quadrivalent human papilloma virus vaccination. CMAJ. 2008;179(6):525-33. 15. Lippman A. Human papillomavirus (HPV) vaccination and the development of public policies. J Epidemiol Community Health. 2008;62:570-1. 16. L i p p m a n A , M e l ny c h u k R , S h i m m i n C , B o s c o e M , H u m a n papillomavirus, vaccines and women’s health: questions and cautions. CMAJ. 2007;177(5):484-7.


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