HPV vaccine awaiting Health Canada approval

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.

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.

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.

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

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