Girl who died after HPV vaccine had underlying condition
Published Tuesday, September 29, 2009 9:54PM EDT
While the news of a 14-year-old girl dying within hours of receiving an HPV vaccination has worried many across Britain, health officials are stressing there is no reason to think the vaccine killed the girl.
Natalie Morton, 14, died Monday after receiving a vaccination at her Coventry-area school containing Cervarix, a vaccine made by GlaxoSmithKline that helps protect against the virus that causes cervical cancer.
She had a "serious underlying medical condition which was likely to have caused death," Dr. Caron Grainger, the director for public health at Coventry City Council, said in a statement Tuesday.
"We are awaiting further test results which will take some time. However, indications are that it was most unlikely that the ... vaccination was the cause of death."
Cervarix is not available in Canada, but it is going through the federal approval process. GSK Canada has applied to Health Canada for approval of its vaccine and expects a response by early next year.
In this country, all 10 provinces as well as the Yukon that have HPV vaccine programs use Gardasil, made by Merck Frosst.
The exact cause of Morton's death is not yet known. Morton appeared to be healthy before being given the shot. An autopsy will be carried out to see if there was any link between the teen's death and the vaccine, said Grainger.
"No link can be made between the death and the vaccine until all the facts are known and a post mortem takes place," Grainger said. "We are conducting an urgent and full investigation into the events surrounding this tragedy."
A small number of other girls at the Coventry school reported mild symptoms, such as dizziness and nausea, health officials said. Glaxo warns in its product information insert that side effects such as muscle pain, nausea and diarrhea have been noted on occasion with Cervarix vaccinations.
The batch of the vaccine used has been quarantined to test whether it was faulty or contaminated.
As well, the National Health Service in Coventry said it had halted its vaccine program in the city for two days, to give staff administering the vaccine training in how to answer questions from anyone concerned about its safety.
"We fully expect to resume the program in the coming days," the health authority said in a statement.
Britain's Department of Health said there were no plans to halt the program nationwide.
"The vaccine has a strong safety record so precautionary measures are focused on the batch," it said in a statement.
The National Health Service began offering Cervarix to teenage girls last year. More than 1.4 million doses of the vaccine have been given out so far under the program.
The cervical cancer vaccine is routinely administered to millions of young girls across Europe and North America; Cervarix has been approved for sale in 98 countries worldwide. Few safety concerns about the vaccines have been raised elsewhere.
Dr. Pim Kon, medical director at GlaxoSmithKline UK, said in a statement that the company is working with the Health Department and health regulators to investigate the case and that the exact cause of death was not yet known.
The statement added that the majority of suspected adverse reactions to the Cervarix vaccine so far have related "either to the signs and symptoms of recognized side effects listed in the product information or were due to the injection process and not the vaccine itself."
Like Gardasil, Cervarix is administered in three separate shots over six months and protects against strains of human papillomavirus, or HPV.
Gardasil protects against four HPV strains: two that cause 70 per cent of cervical cancers, and two that cause genital warts. Cervarix protects against two HPV strains that are linked to 80 per cent of cervical cancers; the shot does not protect against warts.
It's estimated that about 1,350 women are diagnosed with cervical cancer in Canada every year, and about 400 women die. It is the second most common type of cancer diagnosed in women between 20 and 44 (breast cancer is the most common cancer diagnosed in women of this age group).
While cervical cancer progresses relatively slowly and Pap tests can detect the cancer at its earliest stages, the rates of Pap screening in most industrialized countries are not as high as they should be.