Seasonal flu shots: Are they responsible for the adverse reactions? Investigations on

By Dr. Ananya Mandal, MDApr 28 2010

After the seasonal flu vaccines caused over 250 cases of fever, vomiting and convulsions and one reported death in under-fives there has been intense investigations to detect the cause. Further vaccinations were stopped last Friday.

The World Health Organization had advised against the use of three in one flu vaccines with the H1N1 swine flu strain mixed with two seasonal flu strains in a one-shot vaccine says the new report from The Therapeutic Goods Administration. WHO recommendation, accessed via a link on the TGA website says, “At this time, WHO is not in a position to advise whether there should be one trivalent influenza vaccine containing all three viruses, or whether there should be separate vaccines for pandemic and seasonal influenza,” the WHO advice, dated September 23 last year. It adds, “WHO will be in a position to provide guidance on this issue after the Strategic Advisory Group of Experts meets in late October and deliberates on this issue.”

The TGA's Australian Influenza Advisory Committee met on October 2 and approved the world-first ‘three-in-one’ combination. At the SAGE deliberations three weeks later the same three in one shot was approved with a clause that either the three in one shot or individual shots may be given “subject to national needs”. It went on to say that southern hemisphere countries like Australia could choose the three in one vaccine and encouraged to donate any surplus swine flu vaccine to the WHO. SAGE confirmed that “little immunogenicity data are currently available” in case of children from six months to 10 years. It said, “SAGE recognises there is no indication at this stage that unusual adverse reactions are being observed…In spite of these preliminary reassuring results, continued vigilance and regular evaluation by health authorities are needed.”

At present health authorities are investigating the adverse reactions to the vaccines in detail especially after the death of a two year old girl barely 12 hours after the flu shot on the 9th of April. The initial autopsy did not point towards the vaccine as a cause of death in the girl.

The federal Health Department's Technical Advisory Group on Immunisation (TAGI) is heading the investigation. Chairman Terry Nolan said last night that the Australian Childhood Immunisation Register was not up to date and added, “We still have concerns about the accuracy of the data.” He expressed doubts regarding the inclusion of swine flu vaccine in the seasonal flu as the cause for such reactions.
CSL, a Melbourne based pharmaceutical company that made the flu shots denied that the particular batch was responsible for the reactions. A spokesman said this Tuesday, “CSL is continuing to work with the Therapeutic Goods Administration (TGA) and WA Health to urgently investigate the adverse event reports… What we have been able to analyze so far indicates that it is not batch related...our evidence shows it was not a bad batch.”

At present vaccination techniques is also scrutinized for clues. The Australian Medical Association (AMA) has also urged more details of vaccination and adverse events from SA Health. The data collated at the TGS might shed some light. AMA South Australian president Andrew Lavender feels, “The medical community believes there should be nothing to hide, so why give that perception? I think the more information we can put out there with the public and with the medical profession, I think the more informed discussion we can have….But in the absence of information then I think we're going to end up with some confusing and possibly some downright wrong speculation. The public needs to know and the medical profession needs to know so that parents who are concerned about vaccination can be given adequate information to make informed decisions.”