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Coroner inquest and HPV vaccine - expert responds

Coroner inquest and HPV vaccine
- expert responds

9 August 2012

Claims relating to vaccine safety are back in the media spotlight as an inquest into the unexplained death of teenager Jasmine Renata in 2009 continues.

The family has told the coroner they believe the death is linked to the Gardasil vaccine for human papilloma virus (HPV) that Ms Renata received six months earlier, and today testimony from overseas witnesses providing health-related information to support these claims has been heard via video link.

Dr Helen Petousis-Harris, Academic Lead, Immunisation Research and Vaccinology, Immunisation Advisory Centre, comments:

"Data on the safety of Gardasil vaccine continues to accumulate globally and supports the excellent safety profile of this vaccine. More than 40 million doses of this vaccine have been distributed globally. There are now a number of very large post licensure studies that compare vaccinated with unvaccinated people showing there is no increase in risk for unexpected adverse outcomes associated with the Gardasil vaccine.

"Examples of vaccine safety monitoring systems include the US Vaccine safety Datalink (VSD) project which has data for over 9 million people each year and compares outcomes in vaccinated and unvaccinated people and the European Vaccine Adverse Event Surveillance and Communication (VAESCO) which also has information for a very large population. There have been no concerns about the safety of Gardasil vaccine identified. In contrast, many countries (including NZ) who have introduced this vaccine have observed dramatic decreases (>50%) in the rates of new cases of genital warts and early signs of a decrease in cervical disease."

In response to reports of claims made by a 'health expert' at the inquest:

"I find the claims bizarre. Gardasil is certainly likely to have residual fragments of HPV DNA in it as the vaccine is manufactured using a gene form the HPV virus. This is the case for any medicinal product manufactured using recombinant technology. This is not considered contamination and not considered a risk to vaccine recipients. The generation of human papillomavirus from the vaccine is actually not possible as there is no virus in the vaccine, only a virus-like particle comprised of a single viral protein. There is no infectious capacity.

"Most scientists find it difficult to get recombinant DNA into human cells and then get protein expressed. There would need to a significant amount of viral DNA that somehow finds its way into the humans cells with intact promoter and regulatory regions (and we already know that the tiny amount of residual DNA in the vaccine is highly fragmented) and then this would only be able to occur in the muscle cells where it was injected. Furthermore it would take another string of extraordinary events for an adverse event to also occur. To the best of my knowledge none of this work has been either replicated by other scientists or peer reviewed and published."

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