More study needed on HPV vaccine

By 
  • July 27, 2008

{mosimage}TORONTO - Thousands of reports of adverse effects from a vaccine used to protect against cervical cancer raise further questions about a controversial mass vaccination program for young women in Canada, says the head of a Catholic bioethics group.

Touted as a vaccine for women, Gardasil, which is made by Merck Frosst Canada Ltd., is the first vaccine developed to prevent cervical cancer caused by certain strains of human papillomavirus, also known as HPV, which is a sexually transmitted virus. But a soon-to-be-released report by the U.S. Centres for Disease Control and Prevention says close to 10,000 people reported adverse effects to Gardasil.

“Long-term testing didn’t seem adequate (in Canada),” said Moira McQueen, executive director of the Canadian Catholic Bioethics Institute in Toronto. “I’ve said this before. It did seem to me that on the evidence of the lens of the studies, Gardasil was being rushed along more than it needed to be.”

Plans of mass vaccinations in schools have sparked a national debate since the federal government earmarked $300 million last year for a national vaccination program for Gardasil. Catholic groups in Canada have raised ethical concerns, saying it encourages sexual activity in young girls. The vaccine is said to be most effective for pre-teen girls.

Curtis Allen, spokesperson for the Centres for Disease Control, told The Catholic Register July 22 from Atlanta that the U.S. federal agency received about 9,749 reports of adverse effects and 20 deaths since Gardasil was licensed two years ago by the U.S. Food and Drug Administration. None of those deaths have been confirmed as attributable to Gardasil. Fainting and pain at the injection site were among the reported adverse effects.

Allen said there is no cause for alarm regarding the reports to the centre’s Vaccine Adverse Event Reporting System up to June 30. Less than seven per cent of those who reported adverse reactions were deemed serious, which included hospitalization, he said.

More than 13 million doses have been distributed in the United States since the drug was licensed two years ago.

These reports do not suggest a “cause and effect” and constitute an “early warning system,” Allen said.

McQueen said her objections to Gardasil were mainly based upon moral considerations. Young girls should be encouraged to view sexual activity within the sacrament of marriage, she said.

And in a letter about the vaccine, the Ontario Conference of Catholic Bishops reiterated the importance of teaching abstinence and said “parents have the right and responsibility to decide whether their daughters should be vaccinated.”

HPV is considered a “highly prevalent infection,” according to a 2007 Public Health Agency of Canada report. It is estimated that 1,300 women are diagnosed with the disease each year. About 400 women die from cervical cancer, making it the second most common cancer for women.

The agency said 212 people reported adverse effects from Gardasil as of June 30.

“Gardasil, like all vaccines, underwent extensive testing and clinical trials before it was approved for use in Canada. It is safe and effective at preventing four types of HPV infections in girls and women nine-26 years old,” said Public Health Agency of Canada spokesperson Jacinthe Perras in an e-mail.

No deaths were reported and six people were hospitalized, but only one was found to be “possibly related to the vaccine,” while another is being reviewed. The most common types of adverse reactions were pain at the injection site, headache, vomiting and fainting. Reports of serious side-effects included hospitalization where one patient experienced a swelling of the brain, Perras said.

Meanwhile, the Canadian Women’s Health Network said all of the information about Gardasil’s effectiveness isn’t in yet.

“We need more analysis about data coming out of the (United States) right now and we need data in Canada as well,” said Ellen Reynolds, communications director for the network, which authored a study in the Canadian Medical Association Health Journal last year. In its latest report on Gardasil, the network said “one year later, there are perhaps even more questions than answers.”

Free vaccines started last year in Nova Scotia, Ontario, Newfoundland and Prince Edward Island. Other provinces are planning vaccines this fall including Quebec and British Columbia.

The Toronto, Hamilton, York, Dufferin-Peel Catholic school boards plan on giving the vaccinations to students whose parents request it. But the Halton Catholic board pulled its support for Gardasil in June.

The Public Health Agency of Canada estimates more than a half-million doses of Gardasil have been distributed across Canada since it was licensed two years ago.

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