Children Convulse from Dangerous Vaccines

An unusually high number of children under five years of age experienced fevers, vomiting and seizures after having the flu shot in March and April last year, prompting a call for an inquiry.

The federal government's response to a large number of adverse reactions to the flu vaccine last year has been deemed appropriate by an independent auditor.

Former chief medical officer Professor John Horvath conducted the review, which pointed to a more coordinated plan to quickly and effectively deal with concerns about vaccines.

Just over a month after commencing the program in March last year, the chief medical officer of Australia suspended the vaccine for all children under five after a number of seizures were reported by hospital staff.

Within days, the Therapeutic Goods Association received "a lot of calls" from immunisation service providers about children having high temperatures and being unwell, some with seizures, immediately following the vaccine.

Staff in South Australian hospitals and clinics reported making calls to their WA counterparts to compare the children's adverse reactions.

The report detailed 14 convulsion episodes reported by April 19 in WA as well as several in South Australia and Queensland; four days later the program was suspended.

The independent review found that the actions of the TGA and chief medical officer were appropriate, timely and proportionate, following the extensive investigation.

The fact that there was insufficient data on the vaccines, particularly as there was no clearly identifiable reason to explain the seizures, was much of the reason behind its suspension.

Parliamentary Secretary for Health and Ageing Catherine King said the review noted there was no standard operating procedure for responding to a vaccine safety issue in large groups of people.

"The review identified that the arrangements for vaccine safety issues are complex and, while the Therapeutic Goods Administration has the key responsibility in monitoring adverse events, many other organisations, including Commonwealth and state health authorities, also have a role," Ms King said.

"The 2010 flu vaccine health alert highlighted 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 safety signal."

Other recommendations cover surveillance, the need for timely reporting of adverse reactions following immunisation, raising awareness and more transparency by the TGA to ensure better access to vaccine safety information.

Head of Clinical Research at the National Centre for Immunisation and Research and Surveillance at the Westmead Children's Hospital in Sydney, Professor Robert Booy, welcomed the findings and said they addressed some crucial points.

"There is no doubt that improving communication about health matters with the public and profession, as well as increasing the transparency of the regulatory agency, the TGA, will be of benefit," Professor Booy said.

"The best way we could get early signal of a safety concern would be to have active surveillance; linking records generated about vaccine uptake, GP presentation and hospital admission in real time.