Disseminated varicella zoster virus infection following live attenuated herpes zoster vaccine: descriptive analysis of reports to Australia's spontaneous vaccine pharmacovigilance system, 2016-2020.

OBJECTIVES: To examine the reported incidence and features of disseminated varicella zoster virus (VZV) infection following live attenuated herpes zoster vaccine live (ZVL: Zostavax, Merck) in immunocompromised people in Australia. DESIGN AND SETTING: ZVL was funded in 2016 in Australia for people aged 70 years, with a catch-up programme for those 71-79 years. From 2016 to 2020, three deaths due to disseminated vaccine-strain VZV infection occurred following inadvertent ZVL administration in individuals with varying levels of immunocompromise. This descriptive study examined 4 years of national surveillance data reported to the Therapeutic Goods Administration's Adverse Event Monitoring System (AEMS). Denominator data for rates were from doses recorded in the Australian Immunisation Register. PARTICIPANTS: Individuals vaccinated between 1 November 2016 and 31 December 2020 who experienced adverse event(s) following immunisation (AEFI) after ZVL recorded in the AEMS. PRIMARY AND SECONDARY OUTCOME MEASURES: Rates and outcomes of confirmed (Oka strain positive) or probable disseminated VZV infection, and inadvertent administration of ZVL in immunocompromised individuals. RESULTS: 854 AEFI were reported from 1 089 966 doses of ZVL administered (78.4 per 100 000 doses). Of those, 14 were classified as confirmed (n=6, 0.55 per 100 000) or probable (n=8) disseminated VZV infection. The confirmed cases were all hospitalised, and most (5/6) were immunocompromised; three cases died. Thirty-seven individuals were reported as vaccinated despite a contraindication due to immunocompromise (3.4 per 100 000), with 12/37 (32%) hospitalised. CONCLUSIONS: Disseminated VZV is potentially life-threatening and occurs mostly in those with severe immunocompromise. Inadvertent administration of ZVL to immunocompromised individuals has occurred despite initial provider guidance and education. Multiple additional strategies to assist providers to identify contraindications have been implemented to prevent adverse outcomes.

How accurately does the Australian Immunisation Register identify children overdue for vaccine doses? A national cross-sectional study.

Abstract: The accuracy of data recorded in the Australian Immunisation Register (AIR) is important for assessment of population-level vaccine coverage but has not been assessed nationally since 2001. We undertook a cross-sectional study in five states in 2017 using standard criteria to validate AIR records classified as three months overdue for any vaccine at 12, 24 and 48 months. Of 2,000 records selected for audit, 905 were assessable, of which 124 (14%) were misclassified as overdue (errors). Among 563 general practice (GP) records, 91 (16.1%) were errors. Compared with Victoria (1/99; 1%), errors were significantly higher in Western Australia (11/106; 10.4%), Queensland (13/104; 12.5%), South Australia (23/110; 20.9%) and New South Wales (43/144; 29.9%); p < 0.01 for all. Among 165 council and community health centre providers, the overall error rate (17; 10.3%) was non-significantly lower than for GP providers, with an odds ratio (OR) of 0.6 and a 95% confidence interval (95% CI) of 0.3-1.1, and did not differ between states. Records were transmitted to the AIR by paper-based methods in 13 cases, with significantly higher error rates (7/13; 54%) than for practice management software (77/630; 12.2%); OR 9.8 (95% CI 2.8-36.4) or the AIR secure site (23/87; 26.4%); OR 2.6 (95% CI 1.4-4.5). Accuracy is increasingly important, with mandatory reporting to the AIR for all National Immunisation Program vaccines from July 2021, and best achieved by uniform use of practice management software.

HPV vaccination coverage: slightly improved two-dose schedule completion estimates and historical estimates lower on AIR than HPV Register.

OBJECTIVE: To compare Australian Immunisation Register (AIR) human papillomavirus (HPV) vaccination coverage against historical data from the former National HPV Vaccination Program Register and estimate two-dose vaccination coverage. METHODS: Cross-sectional analysis of registry data for adolescent birth cohorts (1998-2007). Denominator populations were Medicare enrolments (AIR) and ABS estimated resident populations (HPV register). RESULTS: For adolescents aged <17 years, AIR coverage estimates were several percentage points lower than HPV register estimates due to a larger Medicare enrolment denominator. Completed course coverage (two or three valid doses) for 15-year-old females in 2020 was 81.5% and for males 78.6%, higher than completed course coverage in 15-year-olds in 2019 (79.7 and 76.8% respectively). First dose coverage was similar for Indigenous adolescents but course completion was lower, although improving over time. Course completion was slightly lower (3.5-5.7%) in areas of lowest socioeconomic status and greatest remoteness. CONCLUSIONS: Coverage is slightly lower using AIR than HPV register estimates. Moving from three to two doses has slightly improved completion, likely due to the wider dose spacing, but equity gaps remain. IMPLICATIONS FOR PUBLIC HEALTH: An ongoing focus on equity in vaccine delivery is needed. Systems, reminders and catch-up opportunities to ensure course completion remain important.

"No jab, no pay": catch-up vaccination activity during its first two years.

OBJECTIVES: To assess catch-up vaccination of older children and adolescents during the first two years of the "No jab, no pay" policy linking eligibility for federal family assistance payments with childhood vaccination status. DESIGN, SETTING, PARTICIPANTS: Cross-sectional analysis of Australian Immunisation Register data on catch-up vaccination of children aged 5 to less than 7 years before (January 2013 - December 2014; baseline) and during the first two years of "No jab, no pay" (December 2015 - December 2017), and of children aged 7 to less than 10 years and young people aged 10 to less than 20 years ("No jab, no pay" period only). MAIN OUTCOMES: Catch-up vaccination rates for measles-mumps-rubella vaccine second dose (MMR2), by age group, Indigenous status, and socio-economic status; catch-up vaccination of children aged 5 to less than 7 years (third dose of diphtheria-tetanus-pertussis vaccine [DTPa3], MMR1), before and after introduction of "No jab, no pay". RESULTS: The proportion of incompletely vaccinated children aged 5 to less than 7 years who received catch-up DTPa3 was higher under "No jab, no pay" than during the baseline period (15.5% v 9.4%). Of 407 332 incompletely vaccinated people aged 10 to less than 20 years, 71 502 (17.6%) received catch-up MMR2 during the first two years of "No jab, no pay", increasing overall coverage for this age group from 86.6% to 89.0%. MMR2 catch-up activity in this age group was greater in the lowest socio-economic status areas than in the highest status areas (29.1% v 7.6%), and also for Indigenous than for non-Indigenous Australians (35.8% v 17.1%). MMR2 catch-up activity in 2016 and 2017 peaked mid-year. CONCLUSIONS: Linking family assistance payments with childhood vaccination status and associated program improvements were followed by substantial catch-up vaccination activity, particularly in young people from families of lower socio-economic status.

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.

Impact and effectiveness of childhood varicella vaccine program in Queensland, Australia.

BACKGROUND: In November 2005, Australia introduced a publicly funded single dose of varicella vaccine for children aged 18-months. We describe the impact of this program on varicella hospitalisations in Queensland and provide the first assessment of single-dose varicella vaccine effectiveness in Australia since the program commenced. METHODS: Age-standardised varicella hospitalisation rates were calculated for 2000-2014 and pre- and post-public funding period rates compared. Case-control studies were conducted to investigate the association between vaccine receipt and both varicella hospitalisations and uncomplicated varicella emergency department presentations. Cases were matched to controls from a population-based register by date of birth and state of residence. Vaccine effectiveness was calculated as (1-odds ratio)×100%. RESULTS: Compared to the pre-funded period (2000-2003), age-standardised varicella hospitalisation rates declined by more than 70% in 2011-2014 with varicella principal diagnosis rates declining from 5.7 to 1.6 per 100,000 population per year. Varicella vaccine effectiveness at preventing hospitalisation with a principal diagnosis of varicella among children aged 19-months to 6-years was 81.9% (95% confidence interval: 61.8-91.4%), while for emergency department presentations among children aged 19-months to 8-years it was 57.9% (95% confidence interval: 48.5-65.5%). CONCLUSIONS: In Australia, the single-dose varicella vaccination program has substantially reduced varicella morbidity. The single-dose varicella vaccine schedule is moderately-to-highly effective against hospitalisation, but appears less effective against emergency department presentations.

Immunisation coverage annual report, 2014.

This 8th annual immunisation coverage report shows data for 2014 derived from the Australian Childhood Immunisation Register and the National Human Papillomavirus Vaccination Program Register. This report includes coverage data for 'fully immunised' and by individual vaccines at standard age milestones and timeliness of receipt at earlier ages according to Indigenous status. Overall, 'fully immunised' coverage has been mostly stable at the 12- and 24-month age milestones since late 2003, but at 60 months of age, it has increased by more than 10 percentage points since 2009. As in previous years, coverage for 'fully immunised' at 12 months of age among Indigenous children was 3.7% lower than for non-Indigenous children overall, varying from 6.9 percentage points in Western Australia to 0.3 of a percentage point in the Australian Capital Territory. In 2014, 73.4% of Australian females aged 15 years had 3 documented doses of human papillomavirus vaccine (jurisdictional range 67.7% to 77.4%), and 82.7% had at least 1 dose, compared with 71.4% and 81.5%, respectively, in 2013. The disparity in on-time vaccination between Indigenous and non-Indigenous children in 2014 diminished progressively from 20.2% for vaccines due by 12 months to 11.5% for those due by 24 months and 3.0% at 60 months of age.

Trends and patterns in vaccination objection, Australia, 2002-2013.

OBJECTIVES: To examine geographic and demographic trends in objection to vaccination in Australia. DESIGN: Cross-sectional analysis of Australian Childhood Immunisation Register (ACIR) data (2002-2013) for children aged 1-6 years. MAIN OUTCOME MEASURES: Immunisation status according to whether an objection had been registered, and remoteness and socio-economic status of area of residence. Registration of children with Medicare after 12 months of age was used as a proxy indicator of being overseas-born. RESULTS: The proportion of children affected by a registered vaccination objection increased from 1.1% in 2002 to 2.0% in 2013. Children with a registered objection were clustered in regional areas. The proportion was lower among children living in areas in the lowest decile of socio-economic status (1.1%) than in areas in the highest socio-economic decile (1.9%). The proportion not affected by a recorded objection but who were only partly vaccinated for vaccines due at 2, 4 and 6 months of age was higher among those in the lowest decile (5.0% v 3.4%), suggesting problems of access to health services, missed opportunities, and logistic difficulties. The proportion of proxy overseas-born for whom neither vaccinations nor an objection were recorded was 14 times higher than for other children (17.1% v 1.2%). These children, who are likely to be vaccinated although this is not recorded on the ACIR, resided predominantly in major cities. CONCLUSIONS: There was a small increase in registered objection rates since 2002. We estimate that 3.3% of children are affected by registered or presumptive (unregistered) vaccination objection, which suggests that the overall impact of vaccination objection on vaccination rates has remained largely unchanged since 2001. Incomplete records, barriers to access, and missed opportunities are likely to be responsible for most other deficiencies in vaccination coverage.

Evaluating the implementation of the 13-valent pneumococcal vaccine supplementary dose program in Australian primary health care settings.

BACKGROUND: The availability of new pneumococcal conjugate vaccines covering a broader range of serotypes, has seen many countries introduce these into their national immunisation program. When transitioning from 7-valent to 13-valent pneumococcal conjugate vaccines, Australia is one of a small number of countries that included a supplementary dose of the 13-valent pneumococcal conjugate vaccine to offer protection against additional serotypes to an expanded age group of children. An evaluation of the implementation and uptake of the 13-valent pneumococcal conjugate vaccine supplementary dose was undertaken in two local health districts (LHDs) in New South Wales, Australia. METHODS: A self-administered postal survey of immunisation providers in the Northern New South Wales and Mid North Coast LHDs. Trends in vaccine ordering were examined. Coverage was assessed using data from the Australian Childhood Immunisation Register (ACIR). RESULTS: Of the 177 surveys sent, 125 were returned (70%). Almost all providers (96%) were aware of the 13vPCV supplementary dose program though took an opportunistic approach to program promotion and parental reminders. Supplementary doses of 13vPCV were ordered for 37% of the eligible cohort, mostly in the program's first six months. Coverage as recorded on the ACIR was 27%, though was lower in older children and those not due for scheduled childhood vaccines. Of the children who received the 13vPCV supplementary dose, 3% received it at the same time as vaccines due at 12-months of age, and 44% at the time of those due at 18-months of age. CONCLUSION: Despite the high awareness of the program, reported coverage was lower than that for other PCV supplementary dose programs in Australia and internationally. This may be influenced by providers' largely opportunistic approach to implementation, under-reporting to the ACIR or vaccine uptake. Lessons learned from this evaluation are relevant for future time-limited childhood vaccination programs. Prior to commencement, providers should be informed about the importance of catch-up/supplementary vaccination for their patients and their active role in promoting this. They should also receive program information before parents. An understanding of parental reasons for non-receipt of time-limited childhood vaccines and evaluation of the effect of aligning supplementary (or catch up) vaccination programs with the NIP schedule would be useful to inform future programs.

Immunisation coverage, 2012.

This, the 6th annual immunisation coverage report, documents trends during 2012 for a range of standard measures derived from Australian Childhood Immunisation Register (ACIR) data, and National Human Papillomavirus (HPV) Vaccination Program Register data. These include coverage at standard age milestones and for individual vaccines included on the National Immunisation Program (NIP) and coverage in adolescents and adults. The proportion of Australian children 'fully vaccinated' at 12, 24 and 60 months of age was 91.7%, 92.5% and 91.2%, respectively. For vaccines available on the NIP but not assessed during 2012 for 'fully vaccinated' status or for eligibility for incentive payments (rotavirus and pneumococcal at 12 months and meningococcal C and varicella at 24 months) coverage varied. Although pneumococcal vaccine had similar coverage at 12 months to other vaccines, coverage was lower for rotavirus at 12 months (83.6%) and varicella at 24 months (84.4%). Although 'fully vaccinated' coverage at 12 months of age was lower among Indigenous children than non-Indigenous children in all jurisdictions, the extent of the difference varied, reaching a 15 percentage point differential in South Australia but only a 0.4 percentage point differential in the Northern Territory. Overall, Indigenous coverage at 24 months of age exceeded that at 12 months of age nationally and for all jurisdictions, but as receipt of varicella vaccine at 18 months is excluded from calculations, this represents delayed immunisation, with some contribution from immunisation incentives. The 'fully vaccinated' coverage estimates for vaccinations due by 60 months of age for Indigenous children exceeded 90% at 91% in 2012. Unlike in 2011, at 60 months of age, there was no dramatic variation in coverage between Indigenous and non-Indigenous children for individual jurisdictions. As previously documented, vaccines recommended for Indigenous children only, hepatitis A and pneumococcal vaccine, had suboptimal coverage at 60.1% and 73.1%, respectively, although there was a considerable improvement in coverage from 2011, 57.7% and 68.2% respectively. On-time receipt (before 49 months of age) of vaccines by Indigenous children at the 60-month milestone age improved substantially between 2011 (19%) and 2012 (38%) but the disparity in on-time vaccination between Indigenous and non-Indigenous children worsened at the 60-month age milestone from 2011 (from 1.8 to 5.4 percentage points) and remained the same for the 12 and 24-month age milestones. By late 2012, the percentage of children who received the 1st dose of DTPa vaccine dose at less than 8 weeks of age was greater than 50% in all but 1 jurisdiction and greater than 70% for New South Wales, the Australian Capital Territory and Tasmania. Further, by late 2012, the percentage of children who received the 4th dose of DTPa vaccine dose at less than 4 years of age was greater than 30% in 3 jurisdictions. The percentage of children whose parents officially objected to vaccination in Australia was 1.7% and this figure varied by jurisdiction. However, there is a further 2.1% of children whose parents don't officially object but whose children have no vaccines recorded on the ACIR. Coverage data for the 3rd dose of HPV from the national HPV register in the school catch up program was similar to 2011 at 71% but was substantially lower for the catch up program for females outside school (44%-69%), although this was an improvement from 2011.

Acellular pertussis vaccine effectiveness for children during the 2009-2010 pertussis epidemic in Queensland.

UNLABELLED: OBJECTIVES To assess the effectiveness of three, four and five doses of acellular pertussis vaccine against pertussis notification for children aged 1 - < 4 years and 5 - < 12 years, and the effectiveness of three doses of acellular pertussis vaccine against pertussis hospitalisation for children aged 1 - < 4 years. DESIGN, SETTING AND PARTICIPANTS: A population-based retrospective study of children aged 1 - < 12 years residing in Queensland, Australia, during 2009 and 2010. Routinely collected notification, hospitalisation, testing and vaccination data were used to describe notification rates and testing patterns and to assess vaccine effectiveness (VE) by the screening method. MAIN OUTCOME MEASURES: VE against pertussis notification for children aged 1 - < 4 years and 5 - < 12 years, by birth year, and VE against pertussis hospitalisation for children aged 1 - < 4 years. RESULTS: 1961 notifications and 29 hospitalisations were included in the VE calculations. VE point estimates against pertussis notification and hospitalisation in children aged 1 - < 4 years were similar in 2009 and 2010, and ranged between 83.5% and 89.4%. VE point estimates against notification among children aged 5 - < 12 years were between 71.2% and 87.7% in 2009, and between 34.7% and 70.3% in 2010. The numbers of pertussis tests performed for children, particularly polymerase chain reaction (PCR) tests, increased between 2009 and 2010. CONCLUSIONS: Acellular pertussis vaccine provided good protection within the first years of priming, but this waned as age increased. Changes in pertussis testing behaviour, because of increases in PCR use and awareness, may have contributed to increased pertussis notification rates and lower estimates of VE against notification owing to identification of milder disease.