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Cervical Cancer Vaccine is Safe

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The Centers for Disease Control and Prevention (CDC) has announced that results from two-years of data on Merck’s HPV vaccine indicate that the vaccine continues to be safe.

In June of 2006, the Food and Drug Administration (FDA) approved Gardasil® as the first vaccine for the prevention of cervical cancer. Licensed for females ages 9-26, the vaccine’s indication was recently expanded to include the prevention of vulvar and vaginal cancers. CDC recommends routine vaccination with Gardasil® for females ages 11-12, with “catch up” for women ages 13-26.

Questions about almost every new vaccine’s safety begin shortly after they hit the market, and Gardasil® proved no exception. Concerns seemed to peak over the summer amid media reports of side effects - including paralysis, seizures, and death- occurring in patients who received the vaccine. No evidence linked these conditions with Gardasil®, and the Federal agencies responsible for monitoring vaccine safety, CDC and FDA, steadfastly maintained that Gardasil® is safe.

The FDA and CDC have multiple mechanisms in place to monitor vaccine safety, including the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD) Project, and the newly formed Clinical Immunization Safety Assessment (CISA) Network. VAERS is a passive safety surveillance program that collects reports of side effects, both minor and major, that occur in people who receive vaccines that are approved in the U.S. The system depends on the general public, health care professionals, and manufacturers to file reports about adverse events.

VSD, by contrast, is an active surveillance system where CDC works with large managed care organizations to actively collect information on vaccines, including reports of potential vaccine-related side effects. With Gardasil®, VSD looked specifically at several preset conditions that included seizures and Guillain Barre Syndrome (a neurological disease that usually begins as tingling in the extremities and in some cases leads to paralysis). Established in 2001, CISA is a network of six academic centers with expertise in vaccine safety that investigates the biologic basis of adverse events following immunization and provides clinical consultation and review on specific cases. Their HPV related activities to date include detailed clinic review on rare serious adverse event following Gardasil®.

At the October meeting of the Advisory Committee on Immunization Practices (ACIP), the expert group run by CDC that provides guidance of vaccines, researchers reported that analysis based on 375,000 doses of the vaccine given over nearly two years showed no elevated risk of any serious side effects among those vaccinated with Gardasil®. To date, CDC says that 94% of the side effects reported in those who received Gardasil are minor and include fainting, discomfort at the injection site, nausea and headache, all of which are common with vaccines.

For more information, read CDC’s updated HPV Vaccine Safety fact sheet.

 

An Interview with Dr. James Allen

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James R. Allen, MD, MPH was ASHA President and CEO from 2003-2006, a span where HPV first gained notice among policy makers and the public. During this time–which included Congressional hearings on topics ranging from vaccine policy to how well condoms prevent transmission of the virus–HPV gained unprecedented media attention. With the Food and Drug Administration likely to consider applications within the next year that seek to bring new vaccines to market (such as GlaxoSmithKline’s Cervarix) and expand the use of current products (Merck’s request to market Gardasil® to males and women up to age 45), the need for accurate, clear information around all things HPV remains critical. Dr. James Allen

Beyond issues of HPV vaccine policy and marketing, an increasing number of individuals (and their partners) are learning about the virus and, of course, are asking questions. Dr. Allen, now serving as an ASHA consultant, sat down with HPV News recently to share his thoughts about answering some of the thorny HPV questions posed by patients and policy makers alike.


HPV News: HPV vaccines are currently only approved for females ages 9-26, but the FDA may eventually consider expanding their use for males. If an HPV vaccine is licensed for males, what messages will be needed for men and  parents of adolescent boys?
James Allen: The vaccine is well established. It’s been out almost three years now and the basic messages are getting across to the public, so it should be easier to communicate with men and parents of adolescent boys. Obviously, with females the message was clearly “cervical cancer prevention.” Penile cancers aren’t as common as cervical cancers, so the message needs to be moderated a little bit.
Males are affected by HPV, of course. While less frequent than cervical cancers, penile and anal cancers associated with HPV infection are important issues. In addition, a number of cancers of the head and neck are associated with “high risk” HPV strains. Another important consideration with both males and females is that the current vaccine can prevent most cases of genital warts, and that is another important message to get across.

What about men who have sex with men (MSM)? Anal cancers, for example, are very relevant to this population: HIV-positive men have much higher rates of anal cancer compared to the general population. How do you talk to MSM?
I don’t think the messages should be directed at sexual orientation per se, although MSM are at higher risk of some of the severe consequences of HPV infections. In my opinion, it would be best to market the vaccine uniformly to sexually active men. If you are going into a gay community or gay clinic, however, you would certainly want to tailor prevention messages and materials so that they are appropriate, sensitive to the population, and most likely to be effective. To me, though, the primary focus should be sexually active men, particularly since some MSM do not identify themselves as being gay.

Most HPV infection clear spontaneously, but there’s no way to assess if the virus is infectious. How should we respond to questions about HPV in relationships, and those who ask “Do I have to tell a new partner about a past HPV diagnosis?”
This is difficult since treatment for HPV disease is targeted to the manifestation, such as genital warts or cervical cell changes. The underlying infection isn’t necessarily eradicated.

Partners in a mutually monogamous relationship, where HPV is present, probably don’t need to take any unique or special precautions. It isn’t likely they’ll “ping pong” the virus back and forth. This is very different from infections such as trichomonas or chlamydia, where untreated partners can reinfect each other.

But take someone who is without a single, steady partner, which is especially common with young, unmarried sexually active people. It is not very practical to recommend that someone with a past HPV diagnosis – but who no longer has any evidence of the infection – should notify partners. What they need to understand are the standard messages around STDs and risk reduction; use condoms, be cautious, limit the number of partners. I don’t think we tell them anything special around HPV and future partners, though, such as “A year or two ago I was treated for warts, or had an abnormal Pap test.” I don’t think there’s much justification for that. Consider, too, that many of these partners have, or have had, other sexual partners, too, so they likely have other sources of exposure.

The emotional impact of an HPV diagnosis is often way out of proportion to any medical issues that arise. How do we effectively counsel around issues of self-esteem and stigma?
Stigma is difficult, especially with warts, where the genitalia may have an abnormal appearance.  I think it’s important for people to know they can rely on their healthcare providers, so providers need to listen to their patients and try to be as reassuring as possible.  They should certainly avoid being judgmental.

Another concern that people have is that they may lose their sexual freedom, that perhaps partners won’t be willing to have sex with them. A discussion with these people about basic HPV information – the virus is common, usually harmless, most often clears on its own – can also be helpful.

Thinking back on your time at ASHA, what are you the most proud of?
We live in a time of rapidly changing communications technology. A big challenge for ASHA was–and continues to be–figuring out how we can be most accessible to our varied target audiences with the best information. Part of that was to move beyond the call center model to more tech savvy means of communication, including web-based programs such as chat rooms and the message boards. Call centers provide the best means of one-to-one contact, the personal touch, but the electronic programs offer a chance to cost-effectively reach an exponentially greater number of people.

We should always keep in mind, though, that some of the folks who need help the most might not have access to computers and the Internet on a regular basis. Plus, it’s difficult to tailor responses provided via a web-site, as people have different literacy levels and cultural sensitivities that are harder to meet with this approach.

 

A Phase I Trial of a Human Papillomavirus DNA Vaccine

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Researchers say results from phase I trial show a therapeutic HPV vaccine is both safe and able to stimulate an immune response.

Phase I trials involve new drugs and vaccines being tested in a small number of subjects, primarily to evaluate safety; the extent to which a new drug really works is determined in larger phase II and III clinical studies. This study involved 15 subjects, all of whom had HPV 16 and moderate to severe precancerous cervical cell changes (cervical intraepithelial neoplasia, or CIN 2/3). HPV 16 is a “high risk” type found in about half of all cervical cancers.

Subjects were randomized into three cohorts: two groups of three participants that, respectively, received a low or moderate dose of the vaccine. The third group, consisting of nine participants, was given a higher dose of the vaccine.  Each cohort was given three injections of the vaccine (baseline, 28 days, and 56 days).

At 15 weeks from baseline, no serious side-effects were detected among any of the subjects, and an increased antibody response to E7, a cancer-linked protein produced by HPV 16, was found with the mid- and high-dose cohorts.

While safety was the primary focus  in this phase I study it’s worth noting that at the 15 week follow-up interval, no CIN was detected in three of the nine subjects in the high-dose cohort. The authors say that only about ¼ of those in an unvaccinated group would have expected to have total CIN regression over a similar timeframe.

Reference
Trimbel C. Peng S, Kos F, Gravitt P, Viscid R, Sugar E, Pardoll D, Wu TC. A Phase I Trial of a Human Papillomavirus DNA Vaccine for HPV16+ Cervical Intraepithelial Neoplasia 2/3. Clinical Cancer Research, 2009. 15:361-67.

 

Second FDA Response Letter to Merck’s Application for Gardasil® in Women up to Age 45

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The Food and Drug Administration (FDA) recently responded to Merck’s application that sought to extend Gardasil’s® indication for use with older women, and says it wants more information before making a decision.

In 2008, FDA granted a speedy priority review to Merck’s application requesting that women up to age 45 be included in the vaccine’s indication (Gardasil® is currently approved for females ages 9-26). The company based the application on clinical trials data that covered vaccine effectiveness through 24 months of follow-up.

In late June last year, however, the agency notified Merck that questions about the new indication couldn’t be resolved in the time allotted for the review and a decision would have to be tabled until later. In January 2009, Merck announced the FDA sent a second response letter asking for 48-month data, which the company anticipates submitting late in 2009 (meaning an FDA decision likely won’t come before 2010).

 

GSK Sends Final Cervarix® Data to FDA

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GlaxoSmithKline announced it submitted to FDA final data from its cervical cancer vaccine clinical trials.

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