Review of the management of adverse effects associated with ...

The Review has found that the Australian system
has a number of strengths. It is similar to passive
adverse event surveillance systems in comparable
countries and was able to detect the safety signal
associated with the use of the 2010 seasonal
influenza vaccine, take appropriate action and
undertake a rigorous investigation.
The Review has found that the reporting of
adverse events following immunisation could be
more timely. Factors that impact on the timeliness
of reporting include: health professional and
consumer knowledge of how to report; delays in
information exchange between the jurisdictions
and the TGA; reports being sent in batches;
differing forms and protocols used in each
jurisdiction; and a lack of agreed case definitions.
The Review considers that, once the first batch
of case reports had been received by the TGA,
its actions in starting a thorough investigation
were appropriate and timely. The decision of the
CMO to suspend the use of all seasonal influenza
vaccines in young children was also appropriate,
timely and proportionate. The subsequent
investigation was extensive and thorough.
Updates were provided by the CMO to keep
jurisdictions, health professionals, consumers
and the media informed of the findings of the
investigation as they became available.
The Review has found that knowledge and
awareness of the vaccine surveillance system and
its processes and procedures among jurisdictions,
health professionals and consumers could be
improved.
Some health professionals and consumers
felt they were not sufficiently informed of the
unfolding events surrounding the suspension of
the use of seasonal influenza vaccines and the
subsequent investigation, particularly in the early
stages before the suspension was announced.
The Review notes there are significant challenges
in determining how to communicate with health
professionals and the community during the early
stages of an investigation, when there is a level of
doubt about the significance of the events.
There is a perception amongst some stakeholders
that there is a lack of transparency in the
TGA vaccine surveillance processes and that
information about investigations into adverse
events associated with vaccines is slow to be
made public.
The Review has found that the Governance
arrangements for vaccine safety issues
are complex. While the TGA has legislated
responsibility to monitor the safety of vaccines,
many organisations, committees and individuals
have a role, and there is a lack of clarity of the
relationships between these groups and their
roles and responsibilities in vaccine safety
monitoring and responding to the identification
of a possible signal. The Review notes that
there are no Standard Operating Procedures for
responding to a vaccine safety issue that does
not require regulatory action but which has
possible implications for the use of a vaccine in a
vaccination program.
x
Review of the management of adverse events associated with Panvax and Fluvax