The HPV vaccine, one year later

From the Canadian Women’s Health Network

In June 2007, the Canadian Women’s Health Network published the policy paper, “HPV, Vaccines, and Gender: Policy Considerations,” to raise questions and concerns about plans to begin mass vaccination programs against infections with some types of the human papilloma virus (HPV) among schoolgirls in Canada. The last sentence of the paper reads: “At this point in time, there are more questions than answers.”

One year later, there are perhaps even more questions than answers. Nevertheless, provinces and territories have either started school-based vaccination programs, or plan to begin them in the fall of 2008. Thus, parents across the country will be faced with the difficult decision of whether or not to allow their daughters to be vaccinated. And there remain concerns that they will too often lack the full information needed to give authentic informed consent.

We continue to ask: What’s the rush when cervical cancer rates are low and have already decreased substantially through the provision of Pap screening programs? Why was the vaccine campaign launched by the Minister of Finance in a budget speech even before the group set up to harmonize immunization policies in Canada issued its recommendations—a report that we still await? Why spend $300 million for a vaccine when the funding could be applied to effective, holistic sexual and reproductive health programs? In fact, we are concerned that the vaccine may actually divert resources from improving Pap screening so that all provinces might have an organized program.

Research has shown that most sexually active people will experience an HPV infection, but that 80 to 90% of these will clear spontaneously within two years. Only four types of the virus are covered by the vaccine—two of which are associated with the development of cervical cancer—and we still don’t know how long protection lasts. So, even those vaccinated will continue to need Pap tests as they get older.

The criticism that has been hurled at those raising questions about the vaccination program, including those speaking on behalf of the CWHN, has been quite surprising. This is especially true for the CWHN authors of the commentary “Human papillomavirus, vaccines and women’s health: questions and cautions,” published in the Canadian Medical Association Journal in August 2007. We are certainly not the only ones asking questions. In fact, the 56 experts on vaccines and sexual health convened by Health Canada in 2005 to review the vaccine approval process also wanted answers to these questions before they recommended approval of a vaccination program. Unfortunately, they have been fairly silent since then.

For voicing our concerns at CWHN, we have been called irresponsible and even lumped in with fundamentalist groups opposed to the vaccine for moral reasons (worried that the vaccine will promote promiscuous behaviour) and with others who are opposed to vaccines in general. For the record, we at the CWHN are not opposed to the HPV vaccine in itself. Rather, we are opposed to a mass vaccination program at this time in the absence of sufficient long-term evidence of its effectiveness, and in the absence of public debate and full, unbiased information.

A major source of public information on the HPV vaccine has been the media. But, with a few exceptions, media coverage has not provided the full story and, in many cases, has instead misinformed the public. Gardasil is not a “vaccine against cancer,” and we do not now know if it will “prevent 70% of cervical cancers” as has been published in the national media. Yet, this misinformation, which is based more on clever marketing by the manufacturer, Merck Frosst, than on good journalism, continues to appear. The exceptions, for example in the Globe and Mail and the CBC, are investigative reports about the lobbying by Merck Frosst that took place prior to the federal government’s $300 million announcement, and articles that go into detail about the available scientific evidence, as well as articles critical of the government process to approve the vaccine and its failure to provide adequate public information.

In PEI, Nova Scotia and Newfoundland, uptake of the vaccination programs which began last September has been high (around 80%), but in Ontario only 50% of girls eligible for the vaccine have actually received it so far. School-based vaccination programs usually have very high uptake rates, and the low rate in Ontario, where most of the investigative media reports were published, may be because parents have decided to wait until further evidence is known.

The governments of Quebec, British Columbia and Manitoba all recently announced they will be unrolling vaccination programs in the fall of 2008. Without the usual National Immunization Strategy to guide provinces in the implementation of a vaccination program (the Strategy was not used in this case), the authorities in Quebec have decided to provide only two doses of the vaccine to Grade 4 girls, then a third shot when the girls reach Grade 9. The vaccine is approved for use in three doses within six months, so Quebec’s plan would be an “off-label” (unapproved) use of the vaccine. A clinical trial is currently underway to evaluate this method, which may or may not prove to be effective in the long term, but it has not yet concluded.

HPV testing is another area of study. The BC Cancer Agency is conducting the HPV FOCAL Study to determine if a test for HPV in women can replace the usual Pap test, allowing women to be screened less frequently. The study is expected to last from two to four years. There are also studies examining whether or not boys should be vaccinated. While it may be shown that vaccinating boys is not an effective method of HPV prevention, the evidence is not yet available. In the meantime, women and girls are being vaccinated and are certainly bearing a disproportionate burden in the prevention of HPV infection.

Some groups are encouraging governments to put vaccination programs on hold through calls for moratoria, such as in Quebec where plans are in place to begin vaccinations this fall (see sidebar). Beyond our borders, a similar campaign for a moratorium on the HPV vaccine is underway in Spain. And the government of Minnesota in the United States did put its HPV vaccine program on hold to take the time to adequately prepare for implementation, including properly educating the public and determining the sustainability of funding in the long term. In the meantime, the Minnesota government has stated it will continue to depend on its effective Pap screening program for the prevention of cervical cancer.

In Canada, it’s not too late for governments to review the decision to implement mass vaccination programs—to wait until more questions are answered, or at the very least until they have provided a comprehensive public education program. Provincial and territorial governments also need to plan for when the federal government’s contribution of $300 million runs out two years from now, how they will sustain such a costly program. In the meantime, governments could focus on improving Pap screening and sex education—for both girls and boys. Research may later show that the HPV vaccine does help prevent cervical cancer, but for now the data do not merit a mass vaccination program.

As we’ve said from the beginning of this story, the CWHN is not anti-vaccine—not even anti HPV vaccine. But we are critical of how this vaccine was introduced and will continue to keep our eyes on this ball. We encourage others to keep asking questions too and to demand the public education on the HPV vaccine necessary for parents and girls to make informed decisions before the next round of vaccinations takes place.

Quebec groups call for a moratorium on HPV vaccination campaign

By Nathalie Parent
>From the Fédération du Québec pour le planning des naissances

In September 2007, the Quebec government announced that it would launch a human papillomavirus (HPV) vaccination campaign for girls to begin in the 2008 school year, joining other Canadian provinces that have announced similar vaccination programs. The details of the campaign, with an estimated cost of $70 million over three years, were announced in April by the Quebec government stating that the vaccine will be administered to nine-year-old girls in Grade 4 and 14-year-old girls in Grade 9.

The campaign was criticized as soon as it was announced in September, in particular by the Réseau québécois d’action pour la santé des femmes (RQASF) [Quebec women's health network], which called for a moratorium, a position supported by the Regroupement des maisons de jeunes du Québec [Organization of Quebec youth centres], Women and Health Protection and the Canadian Women’s Health Network. The groups urged that the millions of dollars earmarked for the campaign be directed toward prevention and toward improving access to health care for women, in particular for adolescent girls.

In November, the call for a moratorium was taken up by more than thirty groups and individuals representing a variety of interests at an all-day event, “Journée d’étude sur le vaccin contre le VPH,” organized by the Fédération du Québec pour le planning des naissances (FQPN) to examine and discuss the vaccination program. Even after discussions with the public health officials attending the meeting, participants were not convinced of the need to launch such an extensive vaccination campaign so quickly. They felt that the data required to support such a decision were still insufficient, in particular with respect to the duration of vaccine-induced immunity, the need for repeat doses, the vaccine’s long-term effects, etc. They also questioned the approach favoured by public health officials, which is based on expensive new technologies, instead of promoting awareness, prevention and sex education.

Disappointed with discussions with public health officials, the FQPN addressed its call for a moratorium directly in a letter to the Minister of Health and Social Services. The Federation demanded concrete steps aimed at countering the influence of the manufacturer of the proposed vaccine, Gardasil, through increased public education and awareness. The letter also calls attention to the following concerns:

* That the planned vaccination program is not in keeping with a comprehensive view of health or with an essential prevention approach.
* The need to adopt concrete measures to increase access to and improve monitoring of Pap test screening. It is worth noting that the participation rate for women in Quebec is among the lowest in Canada.
* The importance of developing consistent and structured sex education programs.
* The decision to invest in a new and extremely costly vaccine without considering other sexual health issues, in particular prevention of the main sexually transmitted infections, such as Chlamydia, which infects more then 12,500 girls every year in Quebec.
* Public health officials’ unwillingness to undertake an independent and complete information campaign on the realities of cervical cancer, HPV, the vaccine and screening tests.
* The government’s inaction in the face of marketing strategies and aggressive advertising by the manufacturer of Gardasil.

The Minister’s response, delivered by his national director of public health, was a disappointment to the FQPN. Reiterating his intention to proceed with the campaign, the Minister pledged his unconditional support for the recommendations of the Comité sur l’immunisation du Québec [Quebec Committee on Immunization]. In its December report, the Committee recommended that all girls in Grade 4 be vaccinated against HPV in two doses, at the same time as the Hepatitis B vaccination. When the full details of the program were released in April, the government announced that a third dose will be given when the girls reach Grade 9, and that girls under 18 years may receive the free vaccine on request. Finally, the Minister made no reference to the issue of the manufacturer’s influence; moreover, he said nothing at all about the need for awareness and independent information.

Now that it seems unlikely that the government will change its position, the FQPN will continue to raise public awareness about the many concerns related to the Quebec vaccination campaign. For anyone interested in learning more or indeed in getting more involved in this issue, the FQPN invites your participation.

Nathalie Parent is Coordinator at the Fédération du Québec pour le planning des naissances (FQPN) in Montreal, Quebec.

For more information, including tools for education and action on this issue, visit:
FQPN website at www.fqpn.qc.ca/contenu/autresdossiers/vph.php
For more information, visit:

“HPV, Vaccines, and Gender: Policy Considerations,” Canadian Women’s Health Network, June 25, 2007 http://www.cwhn.ca/resources/cwhn/hpv-brief.html (soon to be available in French)

“Human papillomavirus, vaccines and women’s health: Questions and cautions,” by Abby Lippman et al., Canadian Medical Association Journal, August 28, 2007 http://www.cmaj.ca/cgi/content/full/177/5/484