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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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