HPV Immunisation Safety Monitoring - Update 2

The Ministry of Health is aware of one report of a death of a young women following HPV immunisation. This relates to an 18-year-old woman who died suddenly in September 2009, six months after her third immunisation with Gardasil vaccine.

We understand how stressful the death of any young person is for the family concerned. Our sincerest sympathies go to the family.

The Ministry of Health believes it is important not to jump to conclusions about any death until all information is available and considered. The Ministry will continue to monitor this matter and is awaiting the results of the Coroner’s investigation. The Ministry considers that it is very important that whenever a death or adverse reaction has been reported in association with a vaccine or medicine it is fully investigated to identify causation.

The Ministry first became aware of this death towards the end of October 2009. At that time, the Ministry asked for the information to be referred to the Centre for Adverse Reaction Monitoring (CARM) for investigation and whether it had been referred to the Coroner.

The CARM investigation will also be informed by the results of the Coroner’s investigation.

A report to CARM of an adverse event following immunisation is to enable any relationship to be investigated and does not mean the vaccine caused the event. Deaths occur in individuals who have been immunised which are totally unrelated to the immunisation. For example, a death may be due to a pre-existing medical condition (e.g. an undiagnosed heart condition).

The Ministry cannot make a more detailed statement until the Coroner makes his findings available. This can take some time where the death was unexpected because of the comprehensiveness of the investigation required.

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Notes to editors:
The HPV vaccine approved for use in New Zealand has been extensively tested for safety and effectiveness according to international standards. Based on this testing it has been licensed for use in more than 100 countries including Australia, Canada, the US and the countries of the European Union.

To date, over 17 million people have chosen to have the HPV immunisation worldwide, with more than 54 million doses of vaccine distributed.

Reactions to the vaccine are similar to those from other vaccines and include swelling and soreness at the injection site and less commonly fainting or nausea.

The only known severe reaction is serious allergic reactions in rare cases, about 3 cases of anaphylaxis for every million doses of vaccine. Every vaccinator is equipped and trained to respond to anaphylaxis if it occurs and these reactions are treatable.

No deaths have been attributed to HPV vaccine in New Zealand or overseas.