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Zostavax roll out plan underway
Posted 2 June 2016
Progress is being made towards the 1 November roll out of shingles vaccine Zostavax, with the Advisory Committee on the Safety of Vaccines now providing advice on a draft vaccine safety plan.
This follows the addition of Zostavax, which is indicated for the prevention of herpes zoster (shingles) in individuals 50 years and older, to the national immunisation schedule after a budget announcement last month. The vaccine is distributed in Australia by Seqirus.
Now the TGA's Advisory Committee on the Safety of Vaccines (ACSOV) has provided advice on proposed enhanced surveillance activities to monitor adverse events following immunisation (AEFIs).
It says the background age-specific mortality rates in the 70-year-old cohort and in the 71-79 year-old catch up population should be considered, noting that this background information on mortality and morbidity would allow the regulator to differentiate any effect of vaccine on patients.
The committee said patients, carers and healthcare providers should be provided with specific education in conjunction with the vaccine and called for different active surveillance strategies for different AEFIs so that spontaneous reporting from an educated population could be more effective for rarer events, compared to active surveillance.
While the program is only meant to run for two years, the committee said that beyond this, "formal data linkages with the Australian Immunisation Register or appropriate longitudinal studies could be considered, if feasible".
It was also noted that an enhanced surveillance project to monitor AEFIs will be funded via an open tender process, according to a statement from the ACSOV meeting.
Michelle Lam
michelle.lam@lushmedia.com.au
Posted 2 June 2016
Progress is being made towards the 1 November roll out of shingles vaccine Zostavax, with the Advisory Committee on the Safety of Vaccines now providing advice on a draft vaccine safety plan.
This follows the addition of Zostavax, which is indicated for the prevention of herpes zoster (shingles) in individuals 50 years and older, to the national immunisation schedule after a budget announcement last month. The vaccine is distributed in Australia by Seqirus.
Now the TGA's Advisory Committee on the Safety of Vaccines (ACSOV) has provided advice on proposed enhanced surveillance activities to monitor adverse events following immunisation (AEFIs).
It says the background age-specific mortality rates in the 70-year-old cohort and in the 71-79 year-old catch up population should be considered, noting that this background information on mortality and morbidity would allow the regulator to differentiate any effect of vaccine on patients.
The committee said patients, carers and healthcare providers should be provided with specific education in conjunction with the vaccine and called for different active surveillance strategies for different AEFIs so that spontaneous reporting from an educated population could be more effective for rarer events, compared to active surveillance.
While the program is only meant to run for two years, the committee said that beyond this, "formal data linkages with the Australian Immunisation Register or appropriate longitudinal studies could be considered, if feasible".
It was also noted that an enhanced surveillance project to monitor AEFIs will be funded via an open tender process, according to a statement from the ACSOV meeting.
Michelle Lam
michelle.lam@lushmedia.com.au
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