Opinions on Gardasil clash

BY EMMA BAILEY

Girls given the Gardasil HPV vaccine are at least 16 times more likely to have a serious adverse reaction to it than to develop terminal cervical cancer, which critics say raises doubts about the increasingly controversial vaccine.

Information obtained by the Timaru Herald under the Official Information Act shows the death rate for cervical cancer between 2002 and 2005 was 1.95 deaths per 100,000 women.

This compares with 31 serious adverse reactions for the 90,000 girls who have been vaccinated with Gardasil so far.

The reactions being investigated include the death of an 18-year-old woman in September 2009, and reports of epilepsy, Bells Palsy and collapses.

Timaru mother Julie Smith, who created website offtheradar.co.nz after researching Gardasil, said the figures supported her call to have the vaccine withdrawn.

"Parents are not being made aware [of facts about Gardasil] and certainly not by the Ministry [of Health]."

Health Minister Tony Ryall responded briefly to the Herald last night, saying he was advised the Ministry of Health did not have any concerns about the vaccine's safety or effectiveness.

Mrs Smith said the ministry would had been aware of the figures.

"Their main concern cannot be our girls in New Zealand."

The vaccine is given over three doses and provides immunity against four strains of the human papilloma virus (HPV), which manifests as genital warts. The strains are believed to cause 70 per cent of cervical cancers in New Zealand.

Of the girls who contract HPV, 90 per cent will clear the infection without any assistance.

Dr John Holmes, chief adviser of population health at the Ministry of Health, said that at the end of January this year, 90,288 young women had had part or all of the vaccination programme and 243,285 doses of Gardasil were recorded on the National Immunisation Register as having been administered.

As of the same date, 242 suspected adverse events following immunisation and 31 serious adverse reactions had been reported to the Centre for Adverse Reactions Monitoring at the University of Otago.

"The majority of reports were of minor reactions such as pain, redness and swelling at the injection site." Dr Holmes said.

"Of the 242 reports, 31 meet the definition of a serious adverse reaction. Most reports of serious reactions were of short duration eg a faint where recovery was spontaneous without medical intervention.

"A report of an adverse reaction does not mean the vaccine caused the event.

"Investigation and follow-up studies help determine if there is more than a temporal [time] association between events.

"Factors such as medical history, diagnostic tests and other medications given must be examined to help to determine the cause of adverse events."

Dr Holmes said evidence suggested HPV vaccines provided long-term protection with a lack of evidence of any serious adverse effects.

"The Ministry of Health expects that in time HPV immunisation will help halve the number of women who die from cervical cancer in NZ."

Adverse reaction cases

Medsafe defines a serious adverse reaction as one that either results in death, is life-threatening, requires hospitalisation, results in persistent or permanent disability or results in a congenital anomaly.

Thirty-one serious adverse reactions connected to the HPV vaccine Gardasil were reported to the Centre for Adverse Reactions Monitoring.

Death, one case, referred to coroner.

Life-threatening, one case, severe hypersensitive reaction involving tongue swelling.

Intervention required, one case, injection site abscess required draining.

Hospitalisation, four cases, diabetes and eye problems, convulsions and fainting. A report of leukemia but this was not attributed to the vaccine.

Persisting disability, four cases, three reports of general aches and fatigue, one of alopecia.

Emergency department attendance, 20 cases, including nine collapses, seven reports of rashes, two convulsion episodes, one report of severe arm pain and swelling and one report of Bell's palsy (facial paralysis).

- © Fairfax NZ News