Herald Sun
By Jane Metlikovec, Georgie Pilcher and Grant McArthur
May 23, 2007
AUSTRALIAN women will be the first to use a cervical vaccine for older women as a controversy erupted yesterday over anti-cancer jab Gardasil.
The Therapeutic Goods Administration this week approved the Cervarix vaccine in women aged from 10 up to 45.
Cervarix is the first of its kind for women over 26 and may be available in months, according to maker GlaxoSmithKline
Gardasil can only be used in younger women.
Cervarix's approval came as it was revealed dozens of schoolgirls fell ill after receiving their Gardasil shots on May 7.
Five students from Oakleigh's Sacred Heart Girls' College were taken to hospital and another 21 sent to the school sick bay after their jabs.
Health authorities blamed fear and anxiety related to receiving a needle, not the vaccine itself.
Federal Health Minister Tony Abbott urged calm.
"It's not unusual for kids to faint before or after getting a vaccine," he said.
The reactions were not evidence of a serious problem, but he would look into the cases, he said.
The Sacred Heart students are believed to be the first to report side effects since the mass immunisation began in Victorian schools last month.
The vaccine, developed by former Australian of the year Ian Frazer, protects against strains of the human papilloma virus, which leads to 70 per cent of cervical cancers.
It is most effective in females who are not yet sexually active and so have not been exposed.
Year 12 student Natasha D'Souza spent yesterday having tests at the Royal Children's Hospital after she was temporarily paralysed and unable to talk for hours after her May 7 jab.
Natasha, 17, said she felt ill an hour after the injection and collapsed in class.
"My legs and arms were numb. I was paralysed," she said. "I could hear everything that was going on around me, but I couldn't open my mouth."
She was taken to the Monash Medical Centre in one of three ambulances called to get ill students.
Two students remained in hospital overnight.
Doctors told Natasha, who has missed weeks of school, her condition was unrelated to the jab, but mother Delphene D'Souza said it was to blame.
"Doctors say it is an unexplained medical condition, but she is not the only one to have these reactions," she said.
Sacred Heart Girls' College principal Christopher Dalton said the school would continue the vaccinations.
Centre for Adolescent Health director Prof Susan Sawyer said the reactions mirrored those in the US last year, where 253 girls had medical help and 12 were put in hospital after injections.
But a review found no link to Gardasil, she said.
TWO South Australian Christian schools will not offer Gardasil to students because they believe it makes girls promiscuous.
Some US conservative Christian groups want the vaccine banned because they believe young girls are more likely to have sex if their risk of STD is cut.
To summarize this published, peer-reviewed medical journal article: http://content.nejm.org/cgi/content/full/356/19/1991
1. In the FUTURE I trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 2 and grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the only recognized precursors to cervical cancer.
2. In the larger FUTURE II trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the strongest (and many would argue only valid) precursors to cervical cancer.
3. GARDASIL’s protection against cancer associated HPV strains 16 and 18 appears to cause a disproportionate increase in of pre-cancerous dysplasias associated with other HPV strains associated with cervical cancer “raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18.”
4. Even if look only at the FUTURE II results (in which for some reason GARDASIL performed better among the general female population), we are talking about just a 17% decrease in all high grade dysplasias — many of which would spontaneously regress without treatment. So we would have vaccinate 129 women (at about $500 for the three shot regimen) to avoid a single, eminently treatable dysplasia. That’s about $60,000 per dysplasia prevented.
This is all directly from the article linked above.
I myself would add that the use of a highly pharmacologically alum adjuvant as the sole "placebo" in both the FUTURE I & FUTURE II studies makes it impossible to accurately assess the overall risks of vaccination vs. non-vaccination in the real world. Furthermore, the fact that GARDASIL has been studied for safety in just a few hundred pre-teens (again using an alum injection as the "placebo") is highly problematic.
Finally, even though we don't have any decent quantitative numbers concerning GARDASIL's safety (especially on a pre-teen population), we must consider that vaccines in general are not 100% safe. They can cause juvenile arthritis, Guillain-Barre syndrome and other major complications (such as temporary paralysis, fainting, and persistent pain, swelling and itching) in a small subset of the population. Vaccines are not like other medicines in that they are given to a lot of healthy people who would not otherwise contract any disease with or without vaccination. So vaccines must be reasonably effective for their benefits to outweigh their associated risks.