The use of the controversial Gardasil cervical cancer vaccince on girls as young as 12 by the Government is a “public health experiment”, according to the leading researcher in its development.

Dr Diane Harper, who carried out safety studies to get Gardasil approved, warned of “serious adverse events including death” associated with it, and said that parents should be properly advised of the risks.

The Health Service Executive (HSE) confirmed last month that 1,300 first-year girls received the first dose of the vaccine in May, as part of the limited rollout before it is extended in the autumn.

The vaccine, targeted at school-girls in the 12-13 age group, guards against HPV 16 and 18 viruses which give rise to 70 per cent of all cervical cancers. HPV, or Human Papillomavirus Virus, is sexually transmitted.

The HSE said the vaccine has been shown to be very safe, with 60 million doses already given worldwide.

However, with in excess of 18,000 adverse reactions recorded in the US, including 75 deaths, there are increasing worries about the vaccine. Adverse reactions have also been recorded in New Zealand, Canada and Australia.

A US federal report in 2009 found the vaccine had a 400 per cent 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In an unpublished report on research carried out by many clinicians, seen by the Irish Examiner, Dr Harper claims there is no data showing it remains effective beyond this.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.”

Parents were sent out information packs and consent forms in advance of the vaccination beginning.

However, some parents have expressed reservations about vaccinating their daughters against a sexually transmitted disease at such a young age.

Furthermore, the information campaign accompanying the vaccination programme does not properly inform parents about how HPV is transmitted. In particular, the HSE information pack about the vaccine does not inform parents and/or their children that the chances of contracting a HPV rise according to the number of life-time sexual partners a person has.

The National Immunisation Advisory Council (NIAC) has published a booklet on various viruses. In its chapter on HPV, it says that individuals “can reduce their risk of getting genital HPV infection by changes in sexual behaviour including abstinence from any sexual activity or lifelong monogamy”.

It continues: “Reducing the number of sexual partners and the frequency of new partners will also reduce the risk. Condom use reduces but does not eliminate the risk of sexual transmission of HPV.

This finding is confirmed by Dutch research showing that women who had more than 10 lifetime sexual partners had a 50 per cent chance of contracting a HPV. This compared to women who had a single lifetime sexual partner, who had a 4.2 chance of having contracting the virus.

The information leaflet accompanying the vaccine does not provide this information.

Other experts have also criticised HPVvaccination programmes. In an article in 2008 in the New England Journal of Medicine (NEJM), Drs Jane Kim and Sue Goldie suggest that the vaccination of girls aged 12 and over might only reduce the risk of cervical cancer by two per cent compared to screening alone.

They suggest that this might not be very cost-effective compared with other ways in which the cost of such programmes might be spent.