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The Medical journal of Australia 11/2010; 193(9):492-3. · 2.81 Impact Factor
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ABSTRACT: Australia was one of the first countries to licence a quadrivalent human papillomavirus (HPV) vaccine, rapidly followed by a federally funded program of universal vaccination of a broad age group of females through schools (12 to 18 years) and primary care (19 to 26 years). As of August 2009, more than 5.8 million doses of Gardasil((R)) (quadrivalent; Merck, New Jersey, USA) have been distributed in Australia and a total of 1394 suspected adverse events following immunisation (AEFI) have been reported to the passive surveillance system. Most reports are of common and expected reactions. Case series of more uncommon and serious AEFI, both known to be potentially vaccine related (anaphylaxis, conversion disorders and lipoatrophy) and otherwise (multiple sclerosis and pancreatitis) have been published.
Sexual Health 09/2010; 7(3):320-4. · 1.45 Impact Factor
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ABSTRACT: 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.
Communicable diseases intelligence 09/2010; 34(3):259-76.
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ABSTRACT: The Brighton Collaboration (BC) was established in 2000 with the aim of developing globally accepted standardized case definitions for adverse events following immunizations (AEFI) as well as guidelines for the collection, analysis and presentation of surveillance data. Some of the BC case definitions are complex and this may limit their application for use in post-marketing vaccine surveillance. Barriers to the application of the BC case definitions include an incomplete description of an adverse event and inconsistencies in reporter use of adverse event terms. We have taken the BC case definition for anaphylaxis and developed a clinical checklist and glossary of terms used in the case definition. It is anticipated that these resources can be used at a community level by AEFI reporters. If used, these resources could improve the quality of adverse event reports which would facilitate the application of the BC case definition at a regional and/or national level.
Vaccine 04/2010; 28(28):4487-98. · 3.77 Impact Factor
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ABSTRACT: 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.
Communicable diseases intelligence 12/2009; 33(4):365-81.
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ABSTRACT: This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration for 2007, and describes reporting trends over the 8-year period 2000 to 2007. There were 1,538 AEFI records for vaccines administered in 2007. This is an annual AEFI reporting rate of 7.3 per 100,000 population, the highest since 2003 and an 85% increase compared with 2006 (835 AEFI records; 4.0 records per 100,000 population). The increase was almost entirely due to reports following the commencement of the national 3-dose human papillomavirus (HPV) vaccine program for females aged 12 to 26 years in April 2007 (n = 705 reports) and the national infant rotavirus vaccine program in July 2007 (n = 72 reports). AEFI reporting rates in 2007 were 2.3 per 100,000 administered doses of influenza vaccine for adults aged > or = 18 years, 18.6 per 100,000 administered doses of pneumococcal polysaccharide vaccine for those aged > or = 65 years and 12.7 per 100,000 administered doses of scheduled vaccines for children aged < 7 years. The majority of the 1,538 AEFI reports for 2007 described non-serious events while 9% (n = 141) were classified as serious. Two deaths temporally associated with immunisation were reported; there was no evidence to suggest a causal association. The most significant AEFI reported following HPV vaccine were anaphylaxis (n = 11) and convulsion (n = 18), mostly associated with syncope. The most commonly reported reactions were allergic reaction, injection site reaction, headache and nausea. The data confirm that, despite the low rate of AEFI reporting in Australia, the passive surveillance system is sufficiently robust to detect safety signals which are expected following changes in the immunisation program, allowing these to be investigated further.
Communicable diseases intelligence 12/2008; 32(4):371-87.
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ABSTRACT: Postmarketing surveillance of vaccine safety requires active input from vaccine providers and health care professionals.
The Medical journal of Australia 10/2008; 189(5):243-4. · 2.81 Impact Factor
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ABSTRACT: This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Adverse Drug Reactions Advisory Committee for 2006, and describes reporting trends over the seven-year period 2000 to 2006. There were 779 AEFI records for vaccines administered in 2006. This is an annual AEFI reporting rate of 3.8 per 100,000 population, the lowest since 2002 and a 10% decrease compared with 2005 (869 AEFI records; 4.3 records per 100,000 population). Dose-based AEFI reporting rates in 2006 were 1.9 per 100,000 doses of influenza vaccine for adults aged > or = 18 years, 19.1 per 100,000 doses of pneumococcal polysaccharide vaccine for those aged > or = 65 years and 12.5 per 100,000 doses of scheduled vaccines for children aged < 7 years. Trend data showed transient increases in reporting of AEFI following the introduction of DTPa-IPV combination vaccines in November 2005 for children aged < 7 years. The majority of the 779 AEFI records for 2006 described non-serious events while 11% (n = 85) described AEFIs defined as serious. There was one report of death temporally associated with receipt of dTpa-IPV and typhoid vaccines in an adult with a history of a chronic medical condition. The most frequently reported individual AEFI was injection site reaction in children following a fourth or fifth dose of acellular pertussis-containing vaccine (70 reports per 100,000 doses). The data confirm the low rate of AEFI reported in Australia and demonstrate the ability of the system to detect and investigate signals such as those associated with changes in immunisation programs.
Communicable diseases intelligence 09/2007; 31(3):269-82.
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ABSTRACT: A child with atopy produces IgE antibodies after exposure to common environmental allergens. The atopic diseases (eczema, asthma and rhinoconjunctivitis) are clinical syndromes each defined by a group of symptoms and signs. Not all children with atopy will have atopic disease or develop symptoms after exposure to an allergen. Both genetic and environmental factors determine the development of atopic disease. The presence of specific IgE antibodies to environmental allergens is determined with skin prick or radioallergosorbent testing in children with atopy. Test results should be interpreted in the context of the clinical history and further investigations (eg, allergen avoidance or challenge). Management of atopic disease is frequently symptomatic, but it is important to avoid identified allergen triggers. Immunotherapy may be considered in selected school-age children with severe rhinoconjunctivitis. Preventing atopic disease in high-risk infants and hindering progression of disease in children with established disease are the areas of active research.
The Medical journal of Australia 04/2005; 182(6):298-304. · 2.81 Impact Factor
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ABSTRACT: To assess the reported rate of local reactions after administration of acellular pertussis vaccine (DTPa) according to dose number and type of pertussis vaccine (whole-cell or acellular) used for the primary course, and to document the severity and outcome of fourth-dose local reactions.
Retrospective review. Reports of adverse events after vaccination in South Australia between 1 January 1997 and 31 December 2000 were reviewed, and a questionnaire administered to all parents who reported a local reaction after the fourth dose of DTPa.
The number, and rate per 100 000 administered doses, of local reactions following the primary and booster doses of DTPa, and of local reactions after the fourth-dose in cohorts of children whose primary vaccinations were with either DTPw or DTPa. Redness and/or swelling at the injection site as reported by parents.
Of 581 reported adverse events after vaccination, 138 were local reactions after a pertussis-containing vaccine. Primary vaccinations with DTPa was a significant risk factor for a fourth-dose local reaction (relative risk, 6.7; 95% CI, 2.4-18.5). Parental questionnaires were completed for 45 of the 71 children (63%) with reported local reactions after the fourth dose of DTPa; extensive limb swelling was reported in 8 children (18%) and all except one child had recovered by the time of review.
Parents should be informed that children receiving booster doses of DTPa vaccine, after primary doses with DTPa, are at increased risk of local reactions (which tend to resolve spontaneously) but not of systemic effects. Studies should be initiated to investigate the pathogenesis and the risk of recurrence of local reactions to further improve vaccination schedules.
The Medical journal of Australia 09/2003; 179(4):191-4. · 2.81 Impact Factor
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Michael S Gold
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ABSTRACT: Vaccine safety has become a major community concern and of particular importance for parents, vaccine recipients and vaccine providers. A hypotonic-hyporesponsive episode (HHE) is a sudden and unexpected episode of loss of tone, unresponsiveness and colour change which uncommonly affects infants and children after vaccination. Although any vaccine may be associated with this adverse event, HHE usually follows administration of a pertussis containing vaccine. There has been renewed interest in this adverse event in the light of community concerns regarding vaccine safety. The focus of this interest has been to formulate an acceptable case definition, to document possible risk factors and to better define the outcome of HHE. In addition, studies have documented the outcome of revaccination of children who have had an HHE. Although much remains to be learnt about HHE it would appear that there are no long-term sequelae and that children who have had an HHE can be revaccinated. Parents should be provided with the available information such that they can make an assessment of the risks and benefits of pertussis vaccination. The benefits of pertussis vaccination still outweigh the risk and universal childhood pertussis vaccination should continue to be advocated.
Drug Safety 02/2002; 25(2):85-90. · 3.63 Impact Factor
