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HPV vaccine being probed in UK girl's death awaiting Health Canada approval

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TORONTO - The HPV vaccine given to a 14-year-old British girl a few hours before she died is not authorized for sale in Canada but is going through the federal approval process, says the drug's manufacturer.

GlaxoSmithKline has applied to Health Canada for regulatory approval of Cervarix and expects a response by early next year, company spokeswoman Sacha Kennedy said Tuesday.

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Cervarix protects against two strains of the sexually transmitted human papillomavirus, a major cause of cervical cancer. The vaccine is authorized for use in 98 other countries and also has been submitted for approval in the United States.

Kennedy said it is not known whether Cervarix played a role in the death of Natalie Morton, who was vaccinated Monday at her school in Coventry as part of the U.K.'s national HPV immunization program.

But an official of the National Health Service in Coventry issued a statement late Tuesday saying preliminary autopsy results showed the girl had a serious underlying medical condition that was likely behind her death.

"We are awaiting further test results which will take some time," said Dr. Caron Grainger, joint director of public health for the district. "However, indications are that it was most unlikely that the HPV vaccination was the cause of death."

HPV is the primary cause of genital warts and is responsible for about 70 per cent of cervical cancer cases. About 1,300 Canadian females will develop cervical cancer this year and an estimated 380 will die of the disease.

The only HPV vaccine approved for use in Canada is Gardasil, made by Merck Frosst. The vaccine protects against four strains of HPV and is being provided to girls aged anywhere from nine to 17 through most provincial and territorial governments. Uptake of the vaccination varies widely across the country.

The Public Health Agency of Canada said it had received 555 reports of adverse events following HPV immunization - including 18 hospitalizations and one death.

An investigation into the Canadian death is continuing, but there is no evidence to suggest the vaccine was the cause, the agency says.

Dr. James Bentley, chief of obstetrics and gynecology at Dalhousie University, called both Gardasil and Cervarix "incredibly safe vaccines."

"They're effective vaccines against cancer-causing types of HPV which will prevent cervical cancer in the long term," Bentley said from Halifax.

Dr. Barbara Romanowski, an infectious disease specialist at the University of Alberta, agreed, saying millions of doses of both HPV vaccines have been administered around the world.

"Side-effects have been reported, as one would expect with any injectable vaccine, whether it's flu vaccine or measles, mumps and rubella or HPV vaccine," Romanowski said from Edmonton, where she headed one of the Cervarix clinical trials.

"There is to date no association between administration of the vaccine and serious adverse reactions nor with death."

Ontario has been offering Gardasil inoculations free of charge to Grade 8 girls (usually aged 13 and 14) since the beginning of the 2007-2008 school year, said David Jensen, spokesman for the Ontario Ministry of Health and Long-Term Care.

In the first year of the program, about 40,000 girls (49 per cent of those eligible) were inoculated with the three-dose vaccine and 84 reported adverse events.

"But these have been all minor in nature and mostly involved hives and rash," said Jensen, noting that statistics for 2008-2009 are not yet available.

The introduction of the HPV vaccine has caused a great deal of controversy, with some parents, social commentators and religious groups voicing concerns about the product's long-term safety and efficacy. Some worry it will encourage sexual promiscuity among adolescent girls.

The death of the British school girl could add fuel to that debate.

But Jensen said Ontario will continue to offer the vaccine.

"We wouldn't expect that what's happened in Britain should have an effect on our program here, and we're hopeful that as the awareness grows about the program that we'll see an even larger uptake," he said.

"We're still very confident in the vaccine that's being used here. It went through clinical trials and it's been approved by Health Canada and it's been shown to be safe and effective."

Romanowski said she would advise parents that both vaccines are safe for their daughters and effective in preventing cervical cancer.

"And I personally have not hesitated in vaccinating my own family and would not in the future."

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