Surveillance of adverse events following immunisation in Australia annual report, 2013.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2013 reported to the Therapeutic Goods Administration (TGA) for 2013 and describes reporting trends over the 14-year period 1 January 2000 to 31 December 2013. There were 3,161 AEFI records for vaccines administered in 2013. This is an annual AEFI reporting rate of 13.9 per 100,000 population, the 2nd highest since 2000 and an increase of 59% compared with 2012 (1,994 AEFI records; 8.8 per 100,000 population). The increase was partly due to implementation of enhancements to vaccine safety reporting. This included stimulated reporting of AEFI as part of the extension of national human papillomavirus (HPV) vaccination under the National Immunisation Program to males aged 12-13 years, along with a catch-up program for males aged 14 and 15 years in February 2013 (n=785; includes males and females), in which certain events, such as syncope, were closely monitored. Eighty-two per cent (n=341/414) of the syncope reports were following HPV vaccination and of these 57% (n=195) were males and 43% (n=146) were females. In addition, reporting rates for most other the vaccines were higher in 2013 compared with 2012. The majority of AEFI reports described non-serious events while 5% (n=158) were classified as serious. There were 4 reports of death; however, all deaths were investigated by the TGA and no clear causal relationship with vaccination was found. The most commonly reported reactions were injection site reaction (13%), rash (10%), pyrexia (8%), and syncope (7%).

Surveillance of adverse events following immunisation in Australia, 2012.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2012. It also describes reporting trends over the 13-year period 1 January 2000 to 31 December 2012. There were 1,897 AEFI records for vaccines administered in 2012, a decrease of 22% from 2,417 in 2011. The decrease in 2012 compared with 2011 was mainly attributable to a drop in the reports following receipt of the 23-valent pneumococcal polysaccharide vaccine (405 reduced to 133). However, reporting rates for some other vaccines such as rotavirus and varicella vaccines were higher in 2012 than 2011. Although an increase was observed in estimated reporting rates for rotavirus and varicella in children aged < 7 years in 2012 compared with 2011, it was not statistically significant. There were 370 AEFI records (37.2 per 100,000 doses) for the pneumococcal conjugate vaccine in 2012, which was fewer than in 2011 (43.4 per 100,000 doses). The most commonly reported reactions were injection site reactions (40%), fever (22%), allergic reactions (19%) and rash (10%). Only 7% of all the reported adverse events were categorised as serious. There were 2 reports of death, which were investigated by the TGA and no clear causal relationship with vaccination was found.

Annual report: Surveillance of adverse events following immunisation in Australia, 2011.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2011, and describes reporting trends over the 12-year period 2000 to 2011. There were 2,327 AEFI records for vaccines administered in 2011, a decrease of 40% from 3,894 in 2010. The decrease in 2011 was attributable to a decline in reporting following seasonal influenza (2,354 to 483) and pandemic H1N1 (pH1N1) influenza vaccines (514 to 2). However, reporting rates for some other vaccines were higher in 2011 compared with 2010. The 13-valent pneumococcal conjugate vaccine (13vPCV) replaced the 7-valent pneumococcal conjugate vaccine (7vPCV) and was suspected of involvement in 236 AEFI cases (48 per 100,000 doses). An increase in the number of reports following rotavirus (from 40 to 56 per 100,000 doses), and the hexavalent infant vaccine (from 27 to 40 per 100,000 doses), may have been due at least in part to co-administration with 13vPCV. Reports following DTPa-IPV also increased (from 94 to 139 per 100,000 doses), continuing a trend since 2009. AEFI reports following receipt of the 23-valent pneumococcal vaccine also increased markedly in those aged ≥65 years, from 155 to 288 records. In response to the increase in reports following 23vPPV, boosters are no longer recommended for those without medical risk factors. The most commonly reported reactions were injection site reactions, fever, allergic reactions and malaise. Only 7% of all the reported adverse events were categorised as serious, as per the database definitions, although some events classified as non-serious may have caused severe illness. Three deaths were temporally associated with vaccination; however, all were attributed to causes other than vaccination. The increase in 2011 was predominately due to reports of injection site reactions (49% increase in 2011). Increases in some instances may also be partly attributable to an increasing propensity to report AEFI.

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.

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.

The role of tubulointerstitial inflammation.

BACKGROUND: Exploration of the role of tubulointerstitial inflammation in experimental chronic renal disease (CRD) is an essential step to understanding and finding new treatments for human CRD. Adriamycin nephrosis (AN) is an experimental analogue of human focal glomerular sclerosis and tubulointerstitial inflammation. METHODS: Using murine and rat AN, we have systematically investigated the pathogenic roles of chemokines, costimulatory molecules, and inflammatory cells, such as macrophages and effector and regulatory T lymphocytes. The profile of humoral and cellular mediators was studied in vitro and in vivo. The pathogenic significance of various factors was investigated by DNA vaccination, leukocyte reconstitution and depletion, retroviral transduction, and blockade with monoclonal antibodies. RESULTS: Renal cortical and tubular cell CC-chemokines, including MCP-1, RANTES, and MIP-1alpha, were up-regulated via mediation of NFkappaB, and contributed to disease by attracting inflammatory cells into the interstitium. The role of these chemokines was confirmed by DNA vaccination. CD40-CD40L costimulation signals were involved in expansion and activation of the inflammatory infiltrate, whereas PD-1 signals were inhibitory, and CD28-B7 appeared to have a neutral effect. Macrophage and CD8+ T cells were shown to be effectors of injury, whereas CD4+CD25+ and gammadelta T cells acted as regulatory cells. FoxP3 transduction was able to convert naive T cells to CD4+CD25+ regulatory T cells. CONCLUSION: There is a broad range of humoral and cellular factors involved in the pathogenesis of experimental CRD, some of which are potential targets for treatment of human CRD.

Hypertriglyceridemic waist as a screening tool for CVD risk in indigenous Australian women.

Research has demonstrated that the simultaneous determination of waist circumference and fasting plasma triglyceride (TG) concentrations can identify men characterized by a metabolic triad of unconventional risk variables: increased levels of fasting insulin, apolipoprotein (apo) B, and a predominance of small, dense, low density lipoprotein (LDL) particles. The aim of this study was to assess the efficacy of using "hypertriglyceridemic waist" to identify individuals at high risk of CVD in a sample of indigenous Australian women, for whom 2 of the 3 non-traditional risk factors were measured (apo B and insulin). Subjects (N=80) were divided into subgroups on the basis of waist girth and TG levels. The TG/HDL ratio increased in women with both elevated waist (above 95 cm) and TG levels (above 2.0 mmol/L), who were also characterized by lower HDL and elevated LDL concentrations. Although there was no trend toward an increase in apo B with increasing waist girth and TG levels, apo B concentration was highest among subgroups with elevated waist and TG levels. Fasting insulin levels were higher with increasing waist girth, but not with increasing TG levels. Utilizing hypertriglyceridemic waist as a marker of high plasma insulin and apo B can be an important factor in assessing cardiovascular risk in indigenous Australian women, despite an unexpected apo B distribution.

NSW annual report describing adverse events following immunisation, 2011.

AIM: This report summarises Australian passive surveillance data for adverse events following immunisation in NSW for 2011. METHODS: Analysis of de-identified information on all adverse events following immunisation reported to the Therapeutic Goods Administration. RESULTS: 449 adverse events following immunisation were reported for vaccines administered in 2011; this is slightly higher than in 2010 (n=439) and the second highest number since 2003. The most commonly reported reactions were injection site reaction, fever, allergic reaction and malaise. A large number of injection site reactions were reported following administration of the 23-valent pneumococcal polysaccharide vaccine in adults aged 65 years and over (97.4/100000 doses) and in children aged less than 7 years following administration of the 13-valent pneumococcal conjugate vaccine (29.4/100000 doses) and combined diphtheria, tetanus, pertussis (acellular) and inactivated poliovirus (quadrivalent)-containing vaccines (47.1/100000 doses). Only 10% of the reported adverse events were categorised as serious. There were two reports of death however both were attributed to causes other than vaccination. CONCLUSION: The increased number of reports in 2011 is attributable to the high rates of injection site reactions in children associated with the administration of combined diphtheria, tetanus, pertussis (acellular) and inactivated poliovirus (quadrivalent)-containing vaccines and the 13-valent pneumococcal conjugate vaccine, as well as in adults following receipt of the 23-valent pneumococcal polysaccharide vaccine.

Immunisation coverage annual report, 2009.

This, the third annual immunisation coverage report, documents trends during 2009 for a range of standard measures derived from Australian Childhood Immunisation Register data, including overall coverage at standard age milestones and for individual vaccines included on the National Immunisation Program (NIP). Coverage by Indigenous status and mapping by smaller geographic areas as well as trends in timeliness is also summarised according to standard templates. With respect to overall coverage, the 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. Coverage at 24 months of age exceeds that at 12 months of age, but as receipt of varicella vaccine at 18 months is excluded from calculations of 'fully immunised' this probably represents delayed immunisation, with some contribution from immunisation incentives. Similarly, the decrease in coverage estimates for immunisations due at 4 years of age from March 2008 is primarily due to changing the assessment age from 6 years to 5 years of age from December 2007. With respect to individual vaccines, a number of those available on the NIP are not currently assessed for 'fully immunised' status or for eligibility for incentive payments. These include pneumococcal conjugate and meningococcal C conjugate vaccines, for which coverage is comparable with vaccines that are assessed for 'fully immunised' status, and rotavirus and varicella vaccines for which coverage is lower. Coverage is also suboptimal for vaccines recommended for Indigenous children only (i.e. hepatitis A and pneumococcal polysaccharide vaccine) as previously reported for other vaccines for both children and adults. Delayed receipt of vaccines is an important issue for vaccines recommended for Indigenous children and has not improved among non-Indigenous children despite improvements in coverage at the 24-month milestone. Although Indigenous children in Australia have coverage levels that are similar to non-Indigenous children at 24 months of age, the disparity in delayed vaccination between Indigenous and non-Indigenous children remains a challenge.

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.

Annual report: surveillance of adverse events following immunisation in Australia, 2010.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2010, and describes reporting trends over the 11-year period 2000 to 2010. There were 3,894 AEFI records for vaccines administered in 2010, the highest number reported in any year, and a 63% increase over the 2,396 in 2009. The increase was almost entirely attributable to the large number of reports following seasonal influenza (n = 2,354) and pandemic H1N1 (pH1N1) influenza vaccines (n = 514). In children < 7 years of age, the number of reports following influenza vaccine increased almost 100-fold from 17 in 2009 to 1,693 in 2010 and, for people aged > or =18 years, from 135 to 496. For seasonal influenza vaccine, a disproportionate number of reports were from Western Australia (34%), consistent with more widespread influenza vaccination of children in that state, and 79% were identified as being associated with Fluvax or Fluvax junior (CSL Biotherapies). For pH1N1 vaccine, the number of reports in children < 7 years of age increased from 23 in 2009 to 329 in 2010, but was available for this age group for only 1 month (December) in 2009. In those aged > or = 18 years, for whom the pH1N1 vaccine was available from late September 2009, pH1N1 vaccine reports decreased from 1,209 in 2009 to 109 in 2010. For influenza vaccines, 79% of reports included fever, 45% allergic reactions and 15% malaise. In children aged < 7 years, there were 169 reports of convulsions (127 febrile), compared with 19 in 2009. In contrast, for non-influenza vaccines, reporting rates in children < 7 years of age increased only marginally from 14.1 per 100,000 in 2009 to 19.3 per 100,000 in 2010. Four deaths temporally associated with immunisation were reported but none were considered to have a causal association.

The seroepidemiology of pertussis in NSW: fluctuating immunity profiles related to changes in vaccination schedules.

The pertussis epidemic experienced in NSW in 2008-2009 was likely to be in part due to changes in diagnostic practice since 2007, which amplified disease notifications. We used population-based seroepidemiology as a less biased means of interpreting age-specific pertussis infection patterns in NSW from three serosurveys undertaken in 1997-98 (during an epidemic), 2002 (post-epidemic) and 2007 (inter-epidemic), using a standardised pertussis toxin IgG enzyme-linked immunosorbent assay (ELISA). There was a decrease in the proportion of high anti-pertussis toxin IgG titres (>62.5ELISAUnits/mL) across all age groups in the 2007 serosurvey compared to the previous two serosurveys. In the 2007 serosurvey, the proportion of undetectable (<5ELISAUnits/mL) anti-pertussis toxin IgG titres increased in many age groups. The seroepidemiological profiles of the three serosurveys demonstrate fluctuating immunity profiles related to changes in vaccination schedules.

Annual report: surveillance of adverse events following immunisation in Australia, 2009.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2009, and describes reporting trends over the 10-year period 2000 to 2009. There were 2,396 AEFI records for vaccines administered in 2009, the highest number reported, a 46% increase over the 1,638 in 2008. The increase was almost entirely due to reports related to the introduction of pandemic H1N1 (pH1N1) 2009 influenza vaccine from September 2009 (n = 1,312) largely from the members of the public. The pH1N1 AEFI reporting rate for people aged > or = 18 years was 34.2 per 100,000 administered doses compared with 2.8 for seasonal influenza vaccine. The rates in > or = 65 year-olds were 28.0, 1.6 and 13.3 for pH1N1, seasonal influenza and polysaccharide pneumococcal, respectively. The high reporting rate for pH1N1 vaccine is likely to be at least partly due to enhanced reporting seen for all new vaccines and greater levels of reporting from members of the public in response to the implementation of strategies to encourage reporting, as part of the pH1N1 program. For children < 7 years, AEFI reporting rates in 2009 (14.1 per 100,000 administered doses) were similar to previous years. There were 193 (8%) AEFI reports classified as serious; 6 deaths temporally associated with immunisation were reported but none were judged to have a causal association. As in previous years, the most commonly reported reactions were allergic reaction, injection site reaction, fever, headache, malaise, nausea and myalgia. The most commonly reported reactions following pH1N1 influenza vaccine were allergic reaction (n = 381), headache (n = 289), fever (n = 235), pain (n = 186), nausea (n = 180) and injection site reaction (n = 178). The data within the limitation of passive surveillance provide a reference point for ongoing reporting of trends in AEFI by age group, severity and vaccine type and illustrate the value of the national TGA database as a surveillance tool for monitoring AEFI nationally.

Immunisation coverage annual report, 2008.

This, the 2nd annual immunisation coverage report, documents trends during 2008 for a range of standard measures derived from Australian Childhood Immunisation Register data, including overall coverage at standard age milestones and for individual vaccines included on the National Immunisation Program (NIP). Coverage by indigenous status and mapping by smaller geographic areas as well as trends in timeliness are also summarised according to standard templates. With respect to overall coverage, 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. Coverage at 24 months of age exceeds that at 12 months of age, but as receipt of varicella vaccine at 18 months is excluded from calculations of 'fully immunised' this probably represents delayed immunisation, with some contribution from immunisation incentives. Similarly, the decrease in coverage estimates for immunisations due at 4 years of age from March 2008, is primarily due to changing the assessment age from 6 years to 5 years of age from December 2007. A number of individual vaccines on the NIP are not currently assessed for 'fully immunised' status or for eligibility for incentive payments. These include pneumococcal conjugate and meningococcal C conjugate vaccines for which coverage is comparable to vaccines which are assessed for 'fully immunised' status, and rotavirus and varicella vaccines for which coverage is lower. Coverage is also suboptimal for vaccines recommended for Indigenous children only (i.e. hepatitis A and pneumococcal polysaccharide vaccine) as previously reported for other vaccines for both children and adults. Delayed receipt of vaccines is an important issue for vaccines recommended for Indigenous children and has not improved among non-Indigenous children despite improvements in coverage at the 24-month milestone. Although Indigenous children in Australia have coverage levels that are similar to non-indigenous children at 24 months of age, the disparity in delayed vaccination between Indigenous and non-indigenous children, which is up to 18% for the 3rd dose of DTP, remains a challenge.

Annual report: surveillance of adverse events following immunisation in Australia, 2008.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2008, and describes reporting trends over the 9-year period 2000 to 2008. There were 1,542 AEFI records for vaccines administered in 2008. This was an annual AEFI reporting rate of 7.2 per 100,000 population, a 5% decrease compared with 2007. The majority of AEFI reports described non-serious events while 10% (n = 152) were classified as serious. Two deaths temporally associated with immunisation were reported; there was no evidence to suggest a causal association. The most commonly reported reactions were injection site reaction, allergic reaction, fever and headache. AEFI reporting rates in 2008 were 2.7 events per 100,000 administered doses of influenza vaccine for adults aged > or = 18 years, 18.9 per 100,000 administered doses of pneumococcal polysaccharide vaccine for those aged > or = 65 years, and 17.2 per 100,000 administered doses of scheduled vaccines for children aged < 7 years. Reports for infants increased in 2008, mainly related to gastrointestinal system events temporally associated with receipt of rotavirus vaccine in the 1st full year of the rotavirus immunisation program, while there was a substantial decrease in AEFI reports for human papilIoma virus vaccine in adolescents compared with 2007 when the program commenced. Increases in reports in children and adults were also partly attributed to the implementation of enhanced passive surveillance in Victoria. The consistently low reporting rate of serious AEFI highlights the safety of vaccines in Australia and illustrates the value of the national TGA database as a surveillance tool for monitoring AEFIs nationally.

Indigenous child health: urgent need for improved data to underpin better health outcomes.

Accurate data about Indigenous child health is vital to enable us to understand its current state, to acknowledge achievements, and to determine how to reduce inequalities between Indigenous and non-Indigenous children. We have identified a paucity of national, or nationally representative, data relating to Indigenous child health outcomes, and significant deficiencies in available data. A coordinated national approach will help address current data limitations, including lack of identification of Indigenous status, lack of currency, and lack of information about specific health disorders affecting Indigenous children. To ensure that health data collected are relevant and useful, Indigenous communities must have a role in data collection and management.