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

safety monitoring and investigation into adverse
events following 2010 seasonal influenza vaccination
in young children (TGA 8 October 2010).
Work commenced immediately and involved the
establishment of a TGA expert scientific advisory
panel and a joint ATAGI–TGA Working Group,
supported by the ATAGI Secretariat in OHP. The
Working Group developed templates for data
collection for the epidemiological analyses and
provided them to all jurisdictions on 26 April 2010.
All jurisdictions collected and provided data on
febrile convulsion presentations to emergency
department, vaccine distribution, batch numbers
and clinical data for the validation of cases. The
NCIRS undertook the epidemiological analyses
in consultation with the ATAGI–TGA Working
Group. The TGA also established an expert
panel on vaccine testing, chaired by Professor
Peter Doherty, to advise on the laboratory
investigations. The expertise of the TGA and
its advisory committees and the AHPC all
contributed to the investigation.
Throughout the period of the investigation, the
CMO liaised regularly with state and territory
health officials, TGA, ATAGI, and general practice
and other immunisation provider organisations
to facilitate rapid exchange of clinical and
epidemiological data and dissemination of the
findings as they became available. The CMO also
held regular briefings to keep the community
informed.
Comment
It is apparent from the document review
that there had been a sense among health
professionals and parents in WA and SA that
there was something unusual about the adverse
events profile of the 2010 seasonal flu vaccine
from soon after the start of the vaccination
programs in these two jurisdictions. However,
this did not translate quickly into formal
reports with hard data suitable for confirming
the presence of a signal. At the time that the
immunisation coordinators in WA and SA were
asking for information, TGA had received a small
number (4) of reports of febrile convulsions.
The records indicate that many jurisdictions
were not forwarding reports as they were
received, but were batching them. In some
cases, an AEFI report was sent but did not
mention a febrile convulsion, which was only
identified later during the investigation.
The majority of febrile convulsion reports were
received by TGA only after the jurisdictions
had been prompted to send reports because
of the concerns being raised by WA and SA.
Almost all reports were received by TGA after
19 April 2010.
There also appeared to be some confusion
about what constitutes an AEFI report, when it
is possible to determine that there is a potential
signal, and the subsequent determination of
causality and action to be taken. The Review
considers that, while emails and phone calls
between health professionals are a way of
alerting each other to the possibility that
there is a potential problem, they do not in
themselves constitute confirmation of a signal.
Properly documented and timely case reports
are needed before a signal can be confirmed
and appropriate action be taken. Investigation
of a signal is a complex process involving
confirmation/validation of the cases, active
looking for unreported cases, estimation of
rates and further epidemiological and other
investigations (Global Advisory Committee on
Vaccine Safety 2009).
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Review of the management of adverse events associated with Panvax and Fluvax