THE leading researcher in the development of the cervical cancer vaccine, Gardasil, has called it a “public health experiment” and has warned that parents must be made aware of the serious adverse events associated with its use.
The vaccination programme is set to be rolled out here next month, targeting first- and second-year secondary school students.
However, Dr Diane Harper, who carried out safety studies to get Gardasil approved, warned of “serious adverse events including death” associated with it.
It has already begun on a trial basis, with 1,300 vaccines given in May, and 1,000 vaccines given in July.
The HSE said the vaccine has been shown to be very safe, with 60 million doses already given worldwide.
However, concerns are mounting with in excess of 18,000 adverse reactions recorded in the US, including 75 deaths. Adverse reactions have also been recorded in New Zealand, Canada and Australia.
A US federal report in 2009 found the vaccine had a 400% higher rate of adverse reactions than another comparable vaccine, the Menactra anti-meningitis shot.
The Irish Medicines Board (IMB) said it had received 10 reports of suspected adverse reactions associated with Gardasil.
One was received following the start of the HSE HPV school vaccination programme in May.
Apart from the small risk of being adversely effected, research shows the vaccine only lasts for five years.
In an unpublished report on research carried out by many clinicians, seen by the Irish Examiner, Dr Harper claims there is no data showing it remains effective beyond this.
The paper maintains any risk of permanent disability or death, no matter how rare, must be addressed as women have the choice of a lifetime of cervical screening without vaccination which accomplishes superior cervical cancer prevention.
“If the vaccine does not last at least 15 years, and if vaccination starts at 11 or 12, then women will not be protected long enough to prevent infection.
“We’ve put them at harm from side effects, small but real, for no benefit. This makes Gardasil very expensive with very limited, if any, clinical benefit,” said Dr Harper.
A spokesperson for drug company Merck, which makes the vaccine, said the observation of an event after vaccination, including disease and death, does not mean that vaccination has caused this event or increased the risk, but just that the event occurred after vaccination.
“No investigation has currently led authorities into questioning the good safety profile of Gardasil or into modifying their vaccination recommendations.”
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