Scientific evidence supporting recommendations on the use of the 9-valent HPV vaccine in a 2-dose vaccine schedule in Australia.

The Australian Technical Advisory Group on Immunisation (ATAGI) updated recommendations on the use of human papillomavirus (HPV) vaccines in the Australian Immunisation Handbook in 2018, regarding the use of the recently available 9-valent (9vHPV) vaccine, Gardasil 9, and a 2-dose schedule for young adolescents for HPV vaccines. This report provides an overview of the relevant scientific evidence that underpinned these updated recommendations. The 9vHPV vaccine includes 5 HPV types (HPV 31, 33, 45, 52 and 58) additional to the 4 that are also covered by the 4vHPV (Gardasil) vaccine (HPV 6,11,16,18). Accordingly, the 9vHPV vaccine is expected to prevent an additional 15% of cervical cancers and up to 20% of other HPV-related cancers. Non-inferior antibody responses after two 9vHPV vaccine doses given 6-12 months apart in girls and boys aged 9-14 years compared to women aged 16-26 years after three doses support the 2-dose schedule for adolescents of this age group. In clinical trials 9vHPV vaccine was well-tolerated with a similar safety profile to 4vHPV vaccine. The switch to 9vHPV vaccine and a 2-dose schedule is anticipated to improve public acceptability of the program and reduce HPV-related disease in the long-term.

Children overdue for immunisation: a question of coverage or reporting? An audit of the Australian Immunisation Register.

OBJECTIVE: Vaccinations in Australia are reportable to the Australian Immunisation Register (AIR). Following major immunisation policy initiatives, the New South Wales (NSW) Public Health Network undertook an audit to estimate true immunisation coverage of NSW children at one year of age, and explore reasons associated with under-reporting. METHODS: Cross-sectional survey examining AIR immunisation records of a stratified random sample of 491 NSW children aged 12≤15 months at 30 September 2017 who were >30 days overdue for immunisation. Survey data were analysed using population weights. RESULTS: Estimated true coverage of fully vaccinated one-year-old children in NSW is 96.2% (CI:95.9-96.4), 2.1% higher than AIR reported coverage of 94.1%. Of the children reported as overdue on AIR, 34.9% (CI:30.9-38.9) were actually fully vaccinated. No significant association was found between under-reporting and socioeconomic status, rurality or reported local coverage level. Data errors in AIR uploading (at provider level) and duplicate records contributed to incorrect AIR coverage recording. CONCLUSIONS: Despite incentives to record childhood vaccinations on AIR, under-reporting continues to be an important contributor to underestimation of true coverage in NSW. Implications for public health: More reliable transmission of encounters to AIR at provider level and removal of duplicates would improve accuracy of reported coverage.

Measles high school vaccination program, 2014-2015: online survey of parents in NSW, Australia.

BACKGROUND: In 2014, a high school-based measles supplementary immunisation activity (SIA) took place in New South Wales (NSW), Australia, in response to a large number of adolescents being identified as undervaccinated or unvaccinated against measles. The program focused on areas of NSW where previous measles outbreaks had occurred and where large numbers of undervaccinated adolescents lived. More than 11 000 students were vaccinated in 2014, and the program continued in 2015, when more than 4000 students in Years 11 and 12 were vaccinated. Parents of students vaccinated during the program were surveyed to determine their level of satisfaction with the program. METHODS: An online link to the anonymous survey with instructions was sent in a text message between August 2015 and May 2016 to parents of students who had consented or been vaccinated during the 2014 and 2015 measles, mumps and rubella (MMR) supplementary immunisation activities (SIAs). RESULTS: Responses were received from parents in all Local Health Districts (LHDs), and response rates ranged from <1% to 21% across different districts with 59% of the total number of complete responses from three LHDs. Overall, parents were satisfied with the MMR program, its resources and how it was implemented. Suggestions were received to improve consent processes, increase student involvement and increase school staff accountability. More than half of the parents reported difficulty finding their child's previous vaccination record. Improving vaccination record access and management was highlighted as an area of improvement in the program. CONCLUSION: Although response rates were low, the survey has generated important ideas that may help to further improve implementation of school vaccination programs, including allowing electronic consent, increasing student engagement, improving access to previous vaccination records and increasing school staff accountability.

Closing the vaccination coverage gap in New South Wales: the Aboriginal Immunisation Healthcare Worker Program.

OBJECTIVES: To assess vaccination coverage and timeliness among Indigenous and non-Indigenous children in New South Wales and the rest of Australia, with a particular focus on changes in the vaccination coverage gaps after the introduction of the Aboriginal Immunisation Healthcare Worker (AIHCW) Program in NSW in 2012. DESIGN: Cross-sectional analysis of Australian Immunisation Register data (2008-2016). MAIN OUTCOME MEASURES: Annual estimates of full vaccination coverage at 9, 15 and 51 months of age for Indigenous and non-Indigenous children in NSW and the rest of Australia; differences in coverage between Indigenous and non-Indigenous children at each milestone. RESULTS: The proportion of Indigenous and non-Indigenous children classified as fully vaccinated at 9, 15, and 51 months increased significantly in both NSW and the rest of Australia after the introduction of the AIHCW Program. The mean annual difference in full vaccination coverage between Indigenous and non-Indigenous children in NSW aged 9 months declined from 6.6 (95% CI, 5.2-8.0) during 2008-2011 to 3.7 percentage points (95% CI, 2.5-4.8) during 2012-2016; for those aged 15 months it declined from 4.6 (95% CI, 3.1-6.0) to 2.2 percentage points (95% CI, 1.0-3.4), and for those aged 51 months it declined from 8.5 (95% CI, 7.2-9.8) to 0.6 percentage points (95% CI, -0.6 to 1.8). Reductions in the differences in coverage were not as marked in the rest of Australia. In 2016, there was no statistically significant difference in coverage at any of the three milestones in NSW: at 9 months the difference was 1.6 percentage points (95% CI, -1.0 to 4.1); at 15 months, 0.4 percentage points (95% CI, -2.2 to 2.9); and at 51 months, -1.8 percentage points (95% CI, -4.4 to 0.8). CONCLUSION: Our findings suggest that a dedicated program can help overcome barriers to timely vaccination and significantly improve timely vaccination rates in Indigenous Australian children.

The importance of involving midwives before and during the implementation of an antenatal pertussis vaccination program in New South Wales, Australia.

PROBLEM: Typically there is limited opportunity for stakeholder engagement to determine service delivery gaps when implementing an outbreak or supplementary vaccination program. BACKGROUND: In response to increasing pertussis notifications in NSW, Australia, an antenatal pertussis vaccination program was introduced offering pertussis containing vaccine to all pregnant women in the third trimester. AIM: To explore the effectiveness of consulting with midwives prior to and during a new state-wide vaccination program. METHODS: A pre-program needs analysis was conducted through an online audit of the NSW Clinical Midwifery Consultants followed by a post-implementation audit at 18 months. FINDINGS: Information received from the midwives was utilised during program planning which facilitated program implementation without any major issues in all Local Health Districts. The post-implementation audit provided feedback to program planners that that implementation was continuing consistently and Midwives were found to be very supportive and engaged. DISCUSSION: Education and support of clinicians is vital for high vaccine uptake in new vaccination programs which can be enabled through appropriate educational packages and program resources. CONCLUSION: Consulting with the midwives in advance of a new vaccination program was a new initiative and highly recommended as it was time well spent gaining essential information on program resourcing and operational needs. Conducting a post-implementation audit is also strongly recommended as a check-point for issues and recommendations, to empower frontline staff and support consistent program implementation. Frontline staff engagement before and during implementation of a new vaccination program is a powerful mechanism for effective, efficient and consistent program delivery.

Measles prevention in adolescents: lessons learnt from implementing a high school catch-up vaccination programme in New South Wales, Australia, 2014-2015.

INTRODUCTION: In response to a significant increase of measles cases and a high percentage of unvaccinated adolescents in New South Wales, Australia, a measles high school catch-up vaccination programme was implemented between August and December 2014. This study aimed to explore the factors affecting school-based supplementary immunization activities (SIAs) and to inform future SIA and routine school-based vaccination programme implementation and service provision. METHODS: Focus group analysis was conducted among public health unit (PHU) staff responsible for implementing the SIA catch-up programme. Key areas discussed were pre-programme planning, implementation, resources, consent materials, media activity and future directions for school vaccination programme delivery. Sessions were audio recorded, transcribed verbatim and reviewed. Thematic analysis was conducted to identify the major themes. RESULTS: Two independent focus groups with 32 participants were conducted in January 2015. Barriers to the SIA implementation included lead time, consent processes, interagency collaboration, access to the targeted cohort and the impact of introducing a SIA to an already demanding curriculum and school programme immunization schedule. A positive PHU school coordinator rapport and experience of PHU staff facilitated the implementation. Consideration of different approaches for pre-clinic vaccination status checks, student involvement in the vaccination decision, online consent, workforce sharing between health districts and effective programme planning time were identified for improving future SIA implementation. CONCLUSION: Although many barriers to school programme implementation have been identified in this study, with adequate resourcing and lead time, SIAs implemented via a routine school vaccination programme are an appropriate model to target adolescents.

Adolescent school-based vaccination in Australia.

Adolescents have become an increasingly prominent target group for vaccination in Australia and other developed countries. Over the past decade, voluntary school-based vaccination programs have evolved to become the primary method of delivering adolescent vaccines funded under Australia's National Immunisation Program (NIP). These programs operate at a state and territory level and offer NIP vaccines to adolescents in specific school grades using local teams of trained vaccine providers. This paper summarises the current operation of voluntary school-based vaccination programs in Australia. Information was obtained through a literature review, semi-structured interviews with those managing and implementing school-based vaccination programs in each jurisdiction and a review of program resources. Available coverage data was obtained from each state or territory. Vaccines are delivered at the school, during school hours, and typically target late primary or early secondary school grades. Written parental consent is required for any vaccine to be administered. Operation of the programs is influenced by various factors at the school and provider level. Despite variability in program implementation, collection and analysis of coverage data, comparable coverage has been achieved across all states and territories. Coverage is higher than that reported by other countries where adolescent vaccines are mandated for school entry or available only through community vaccination providers. Voluntary school-based vaccination programs are an established mechanism for the delivery of adolescent vaccines in Australia and vaccines offered will continue to evolve in light of national recommendations. Current gaps in evidence include a detailed understanding of the influence of procedural factors on uptake, the best ways to maximise consent form return and, standardisation of coverage data reporting.

NSW annual immunisation coverage report, 2011.

UNLABELLED: This annual report, the third in the series, documents trends in immunisation coverage in NSW for children, adolescents and the elderly, to the end of 2011. METHODS: Data from the Australian Childhood Immunisation Register, the NSW School Immunisation Program and the NSW Population Health Survey were used to calculate various measures of population coverage. RESULTS: During 2011, greater than 90% coverage was maintained for children at 12 and 24 months of age. For children at 5 years of age the improvement seen in 2010 was sustained, with coverage at or near 90%. For adolescents, there was improved coverage for all doses of human papillomavirus vaccine, both doses of hepatitis B vaccine, varicella vaccine and the dose of diphtheria, tetanus and acellular pertussis given to school attendees in Years 7 and 10. Pneumococcal vaccination coverage in the elderly has been steadily rising, although it has remained lower than the influenza coverage estimates. CONCLUSION: This report provides trends in immunisation coverage in NSW across the age spectrum. The inclusion of coverage estimates for the pneumococcal conjugate, varicella and meningococcal C vaccines in the official coverage assessments for 'fully immunised' in 2013 is a welcome initiative.

NSW annual immunisation coverage report, 2010.

UNLABELLED: This annual report, the second in the series, documents trends in immunisation coverage in NSW for children, adolescents and the elderly, to the end of 2010. METHODS: Data from the Australian Childhood Immunisation Register, the NSW School Immunisation Program and the NSW Population Health Survey were used to calculate various measures of population coverage, coverage for Aboriginal children and vaccination timeliness for all children. RESULTS: Over 90% coverage has been reached for children at 12 and 24 months of age. For children at 5 years of age there was an improvement during 2010 in timeliness for vaccines due at 4 years and coverage almost reached 90%. Delayed receipt of vaccines is still an issue for Aboriginal children. For adolescents, there is good coverage for the first and second doses of human papillomavirus vaccine and the dose of diphtheria, tetanus and acellular pertussis. The pneumococcal vaccination rate in the elderly has been steadily rising, although it has remained lower than the influenza coverage estimates. CONCLUSION: Completion of the recommended immunisation schedule at the earliest appropriate age should be the next public health goal at both the state and local health district level. Official coverage assessments for 'fully immunised' should include the 7-valent pneumococcal conjugate and meningococcal C vaccines, and wider dissemination should be considered.

NSW annual report describing adverse events following immunisation, 2010.

AIM: This report summarises Australian passive surveillance data for adverse events following immunisation in NSW for 2010. METHODS: Analysis of de-identified information on all adverse events following immunisation reported to the Therapeutic Goods Administration. RESULTS: 424 adverse events following immunisation were reported for vaccines administered in 2010; this is 6% lower than 2009 but 24% higher than 2008 and the second highest number since 2003. A total of 274 (65%) adverse events involved seasonal or pandemic influenza vaccines. Reports were predominantly of mild transient events: the most commonly reported reactions were fever, allergic reaction, injection site reaction, malaise and headache. Only 9% of the reported adverse events were serious in nature, including eight reports of febrile convulsions in children following seasonal influenza vaccine. CONCLUSION: The large number of reports in 2010 is attributable to the high rates of fever and febrile convulsions in children after vaccination with 2010 seasonal trivalent influenza vaccine, as well as pandemic (H1N1) 2009 influenza vaccine.

Pandemic (H1N1) 2009 influenza vaccine roll-out in NSW.

The roll-out of the pandemic (H1N1) 2009 influenza vaccine in NSW was significantly different to that envisaged for a pandemic vaccination program. Pre-pandemic planning had focused on the urgent roll-out of a vaccine through mass vaccination clinics in a time of high demand due to a virulent influenza virus. Instead the situation was less urgent, with the vaccine available only after the peak of incidence of infections in NSW. Consequently mass vaccination clinics were considered to be a less appropriate method of delivering the vaccine than a primary care focused delivery model. This paper describes the program, some of the controversies considered during its roll-out and factors to be considered in planning for future pandemics.

NSW Annual Adverse Events Following Immunisation Report, 2009.

AIM: This is the first annual report for NSW of adverse events following immunisation. It summarises Australian passive surveillance data for adverse events following immunisation for NSW for 2009. METHODS: Analysis of de-identified information on all adverse events following immunisation reported to the Therapeutic Goods Administration. RESULTS: 450 adverse events following immunisation were reported for vaccines administered in 2009; this is 32% higher than 2008 and the highest since 2003. The increase was almost entirely attributed to the commencement of the pandemic (H1N1) 2009 influenza vaccine in September 2009. Only 6% of the reported adverse events were serious in nature and the most commonly reported reactions were allergic reaction, injection site reaction, fever and headache. CONCLUSION: Reports of adverse events following immunisation in 2009 were dominated by the pandemic (H1N1) 2009 influenza vaccine. A large proportion of these adverse events were reported directly to the Therapeutic Goods Administration by members of the public. Reports were predominantly mild transient events, similar to those expected from the seasonal flu vaccine.

School-based vaccination in NSW.

Over the past decade the number of recommended and funded vaccines for adolescents has increased, becoming a substantial part of the National Immunisation Program in Australia. In response, NSW has implemented disease-specific vaccination campaigns for both children and adolescents and more recently established a routine high school-based vaccination program to administer vaccines to this often hard to reach group. This paper outlines the history of school-based vaccination in NSW from its commencement in 1971 to coverage from early disease-specific programs, and describes the implementation of the current program of routine vaccination. Substantial coverage has been achieved across the age spectrum 5-17 years, highlighting the effectiveness of the school-based vaccination program in reaching large numbers of adolescents.

NSW Annual Immunisation Coverage Report, 2009.

AIMS: This is the first in a series of annual immunisation coverage reports that document trends in NSW for a range of standard measures derived from Australian Childhood Immunisation Register data, including overall coverage at standard age milestones and for individual vaccines. This report includes data up to and including 2009. METHODS: Data from the Australian Childhood Immunisation Register, the NSW Health Survey and the NSW School Immunisation Program were used to calculate various measures of population coverage relating to childhood vaccines, adult influenza and pneumococcal vaccines and adolescent vaccination, respectively. RESULTS: Immunise Australia Program targets have been reached for children at 12 and 24 months of age but not for children at 5 years of age. Delayed receipt of vaccines is an issue for vaccines recommended for Aboriginal children. Pneumococcal vaccination in the elderly has been steadily rising, although it has remained lower than the influenza coverage estimates. For adolescents, there is better coverage for the first and second doses of human papillomavirus vaccine and the dose of dTpa than for varicella. CONCLUSION: This comprehensive analysis provides important baseline data for NSW against which future reports can be compared to monitor progress in improving immunisation coverage. Immunisation at the earliest appropriate age should be a public health goal for countries such as Australia where high levels of vaccine coverage at milestone ages have been achieved.

Vaccine failures and vaccine effectiveness in children during measles outbreaks in New South Wales, March-May 2006.

During March to May 2006 the highest incidence of measles in New South Wales since 1998 provided an opportunity to estimate the effectiveness of the measles-mumps-rubella (MMR) vaccination program in preventing childhood measles, and describe any differences in clinical presentation between vaccinated and unvaccinated children. We reviewed records of all 33 notified cases of measles in children aged 1-14 years during a state-wide outbreak in New South Wales from March - May 2006. Six of the children had a confirmed history of vaccination with at least 1 dose of MMR. The children with previous vaccination tended to have milder disease than those without vaccination as judged by their reported number of symptoms and hospitalisation rates. The vaccinated children were less likely to have a typical measles rash. Two of the cases in previously vaccinated children may be due to secondary vaccine failure, although a lack of complete diagnostic testing limits our ability to confirm this. Vaccine effectiveness after receiving at least 1 dose of MMR is estimated to be 96% (95% CI 77.8-99%). MMR vaccination was effective in preventing measles in children during these outbreaks.

The effectiveness of prophylaxis for measles contacts in NSW.

OBJECTIVES: As international estimates of the effectiveness of post-exposure prophylaxis of measles vary, we sought to determine the effectiveness of post-exposure prophylaxis with either vaccine or immunoglobulin in susceptible persons with known measles contact. METHODS: Data were obtained on all cases of measles notified in NSW between 1 March and 31 May 2006 and their contacts. The effectiveness of prophylaxis was calculated using the cohort method. RESULTS: During March to May 2006, 57 cases of measles were notified and 1760 measles contacts were identified, of which 553 were classified as susceptible. The calculated effectiveness of post-exposure prophylaxis with vaccine or immunoglobulin in preventing measles was 83.3% (95% CI: 27-96%). CONCLUSION: Post-exposure immunisation remains an effective tool for preventing secondary cases of measles.

Anaphylaxis following quadrivalent human papillomavirus vaccination.

BACKGROUND: In 2007, Australia implemented the National human papillomavirus (HPV) Vaccination Program, which provides quadrivalent HPV vaccine free to all women aged 12-26 years. Following notification of 7 presumptive cases of anaphylaxis in the state of New South Wales, Australia, we verified cases and compared the incidence of anaphylaxis following HPV vaccination to other vaccines in comparable settings. METHODS: We contacted all patients with suspected anaphylaxis and obtained detailed histories from telephone interviews and a review of medical records. A multidisciplinary team determined whether each suspected case met the standardized Brighton definition. Some participants also received skin-prick allergy testing for common antigens and components of the HPV vaccine. RESULTS: Of 12 suspected cases, 8 were classified as anaphylaxis. Of these, 4 participants had negative skin-prick test results for intradermal Gardasil. From the 269 680 HPV vaccine doses administered in schools, 7 cases of anaphylaxis were identified, which represents an incidence rate of 2.6 per 100 000 doses (95% CI 1.0-5.3 per 100 000). In comparison, the rate of identified anaphylaxis was 0.1 per 100 000 doses (95% CI 0.003-0.7) for conjugated meningococcal C vaccination in a 2003 school-based program. INTERPRETATION: Based on the number of confirmed cases, the estimated rate of anaphylaxis following quadrivalent HPV vaccine was significantly higher than identified in comparable school-based delivery of other vaccines. However, overall rates were very low and managed appropriately with no serious sequelae.

Interim estimates of human papillomavirus vaccination coverage in the school-based program in Australia.

In November 2006, the Australian Government announced the National HPV Vaccination Program, consisting of a course of prophylactic human papillomavirus (HPV) vaccine for all Australian females aged 12-26 years. Females aged 12-18 years are vaccinated through school-based programs. The school-based component commenced in April 2007, with the school years targeted varying across jurisdictions. Each jurisdiction maintains comprehensive records of HPV doses delivered in the school-based programs although how this is captured varies. This report presents interim coverage estimates for Year 1 (2007) of the program. Both New South Wales and Victoria achieved coverage of 70% or more among almost all school cohorts vaccinated in the program. Some of the variation in coverage achieved may reflect different levels of experience with school-based programs, and varying methods for school-based vaccine delivery and recording of doses administered. Except for some doses in South Australia, these interim coverage estimates do not include catch-up doses delivered by general practitioners or persons who were vaccinated prior to the onset of the program. Therefore, these data should be considered minimum estimates of coverage. The 1st year of the school-based HPV vaccination program should be considered a success, given time and resource constraints. Public sector immunisation providers across Australia should be commended for planning and implementing a new national immunisation program in approximately 4 months.

EPIREVIEW. Pertussis in New South Wales, 1993-2005: the impact of vaccination policy on pertussis epidemiology.

OBJECTIVE: To assess whether changes in vaccination policy have affected the epidemiology of pertussis in NSW between 1993 and 2005. METHODS: Surveillance data from the NSW Notifiable Diseases Database was reviewed for the period. RESULTS: 35,695 cases of pertussis were notified; annual incidence rates varied from 18.4 to 84.2 per 100,000 people. The highest rates of pertussis were consistently found in infants aged 0-6 months. Rates of disease in other age groups changed markedly over the study period, with high rates currently observed in adult age groups. CONCLUSIONS: New strategies may be needed to control pertussis in infants and in adults who now comprise the largest proportion of cases.