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Glenda Lawrence

Publications and source records attributed to Glenda Lawrence.

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Annual report: Surveillance of adverse events following immunisation in Australia, 2005.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Adverse Drug Reactions Advisory Committee for 2005, and describes reporting trends over the six year period 2000 to 2005. There were 839 AEFI records for vaccines received in 2005. This is an annual AEFI reporting rate of 4.1 per 100,000 population, the lowest since 2000 and a 22 per cent decrease compared with 2004 (1,081 records; 5.4 AEFI records per 100,000 population). The decrease was not consistent across age groups. Reporting of AEFI increased for children aged <1 year in 2005 (60.7 versus 50.3 per 100,000 population) and decreased for the 7 to <20 year age group (0.9 versus 8.9 per 100,000 population). Dose-based AEFI reporting rates in 2005 were 11.0 per 100,000 doses of scheduled vaccines for children aged <7 years and 2.0 per 100,000 doses of influenza vaccine for adults aged >18 years. The majority of records described non-serious events while 9 per cent (n=72) described AEFIs defined as serious. There was one report of death in an older person following influenza vaccine and one of non-polio acute flaccid paralysis in an infant, both temporally associated with immunisation. The most frequently reported individual AEFI was injection site reaction in children following a fifth dose of diphtheria-tetanus-acellular pertussis vaccine (79 reports per 100,000 doses). The increase in the population-based AEFI reporting rate for children aged <1 year in 2005 coincided with the introduction of national immunisation programs for conjugate pneumococcal vaccine in January 2005 and inactivated poliovirus vaccine in November 2005. The fall in reporting rates for older children and adolescents follows the completion of the national meningococcal C catch-up program in early 2005. The consistently low reporting rate of serious AEFIs demonstrates the high level of safety of vaccines in Australia.

Adverse Drug Reaction Reporting Systems↗

Reporting of adverse events following immunization in Australia.

It is an important component of any immunization programme that vaccine safety is monitored by carrying out surveillance for adverse events following immunization (AEFI). Such surveillance can be active or passive. Active surveillance will detect more AEFI, but the vast majority will be minor events. Passive surveillance is probably more appropriate for routine AEFI surveillance, while active surveillance can be used to monitor a new vaccine or to test whether a specific severe event is significantly associated with immunization. Australia has a predominantly passive surveillance system. The system has recently been centralized, providing useful national data on vaccine safety.

Adverse Drug Reaction Reporting Systems↗

Surveillance of adverse events following immunisation: Australia 2002 to 2003.

Reports of suspected adverse events following immunisation (AEFI) are reviewed by the Adverse Drug Reactions Advisory Committee and collated in a central database. We analysed AEFI records for vaccines administered during October 2002 to December 2003, and assessed AEFI reporting trends for 2000 to 2003. AEFI reporting rates were calculated using denominator data from the Australian Childhood Immunisation Register and the annual national influenza vaccination coverage survey. A total of 1,744 AEFI records were analysed for October 2002 to December 2003. The majority described non-serious events; 9 per cent (n=149) described AEFIs defined as 'serious'. Four deaths were reported but none were causally related to immunisation. Dose-based AEFI reporting rates were 2.1 per 100,000 doses of influenza vaccine for adults aged 40 years or over and 19.8 per 100,000 doses of scheduled vaccines for children aged <7 years. The most frequently reported individual AEFI was injection site reaction in children after a fourth or fifth dose of an acellular pertussis-containing vaccine (54 and 98 reports per 100,000 doses respectively). The most frequently suspected vaccine was meningococcal C conjugate vaccine (34% of reports-mostly injection site reactions, gastrointestinal symptoms and headaches). The average annual reporting rate was 7.0 per 100,000 population, the highest to date. The increase in the AEFI reporting rate was due to a greater number of children becoming eligible to receive a fourth or fifth consecutive dose of acellular pertussis vaccine and the introduction of the meningococcal C vaccination program in January 2003 for those aged 1-19 years. The low reporting rate of serious AEFIs demonstrates the high level of safety of vaccines in Australia.

Adolescent↗

Surveillance of adverse events following immunisation: Australia, 2000-2002.

The Adverse Drug Reactions Advisory Committee (ADRAC) database collates notifications of adverse events following immunisation (AEFI) from across Australia. The data were analysed for vaccines received between 1 January 2000 and 30 September 2002. Dose-based AEFI reporting rates were calculated using denominator data from the Australian Childhood Immunisation Register and annual national influenza vaccination coverage surveys. The majority of the 2,409 AEFI records analysed described non-serious events, principally injection site reactions; 10.5 per cent (n = 253) described AEFIs with outcomes defined as 'serious'. Ten deaths were recorded but only one, following yellow fever vaccine, was causally related to immunisation. The average annual population-based reporting rate was 4.5 per 100,000 population. Vaccine dose-based AEFI reporting rates were 2.2 per 100,000 doses of influenza vaccine for adults aged 40 years and over and 14.6 per 100,000 doses of all scheduled vaccines for children aged less than 7 years. The most frequently reported type of adverse event was injection site reaction following receipt of an acellular pertussis-containing vaccine, particularly among children in the age groups scheduled to receive their fourth or fifth doses of the vaccine (overall reporting rate 67 per 100,000 doses). The data highlight the safety of vaccines in Australia, and illustrate both the utility of available immunisation coverage data to estimate dose-based AEFI reporting rates and the value of the ADRAC database as a surveillance tool for monitoring AEFIs nationally.

Adolescent↗