WSJ on meningococcal vaccine for adolescents

Today's Wall Street Journal has a story about meningococcal vaccine -- the cause of many cases of bacterial meningitis -- and the obstacles faced by efforts at vaccinating adolescents. The story, "Quelling a Killer: The Case For the Meningococcal Vaccine," uses the stories of a few victims of bacterial meningitis to illustrate the rapid and severe course of the rather rare disease in the U.S. Estimates vary, but the WSJ story says that 1,400 to 2,800 cases occur annually, roughly 10% of which are fatal.

Routine vaccination (with SanofiPasteur's Menactra) is recommended for all 11-12 year olds, many colleges and universities require vaccination for students living in dormitories (a high-risk group), and now states such as New Jersey are adding the vaccine to those required for school entrance. Despite these efforts, vaccination rates among recommended populations have ample room for improvement.

As these types of stories tend to do, the article includes back-to-back quotes from Paul Offit and Barbara Loe Fisher on the merits and possible concerns, respectively, associated with routine vaccination of adolescents.

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Speaking of the Wall Street Journal, a lengthy story appeared in July -- "Get Your Shots: Adults Need Vaccines, Too" -- detailing the growing number of vaccines recommended for another population, adults, for which awareness of vaccination efforts lags in comparison to pediatric vaccination programs.

Discussing HPV with teens; Overlooking genital warts; New data on South Asian HPV prevalence

A potpourri of recent publications on various aspects of HPV vaccination:

• "Genital warts: Mountains or molehills?" (Lancet Infectious Diseases, Vol. 8, No. 5, 277-278 -- free abstract) -- Co-authored by Sarah Hull and our own Art Caplan, this commentary focuses on genital warts, protection for which is included Merck's Gardasil but not in GSK's Cervarix. The authors discuss how the additional benefit provided by Gardasil may factor in to debates over pricing and the market battle between the two products sure to occur in the U.S. in the years ahead.

• "Informing adolescents about human papillomavirus vaccination: What will parents allow?" (Vaccine, Vol. 26, No. 18, 2203-2210) -- A study by British researchers Vallely, et al., this paper reports on a study using an informational film to improve adolescents' knowledge about HPV, cervical cancer, and HPV vaccinations. The key messages of the film were: 1) HPV causes cervical cancer, 2) HPV is sexually transmitted, 3) Condoms may not fully protect against HPV, and 4) HPV vaccination protects against cervical cancer. A post-screening test revealed improved knowledge regarding the information presented in the film. The adolescents' parents found the messages of the film acceptable.

• "A meta-analysis of human papillomavirus-type distribution in women from South Asia: Implications for vaccination" (Vaccine, Vol. 26, No. 23, 2811-2817) -- One of the unanswered questions regarding the use of HPV vaccines in the developing world is the extent of protection provided by the cervical cancer-causing HPV strains (16 and 18) included in the vaccine. In the U.S., these strains account for approximately 70% of cervical cancer cases. Studies examining the prevalence of these strains in other parts of the world have generally found them to be less common by as much as 10%. This paper, by Bhatla et al, examines nine previously published studies from India. The researchers conclude that HPV 16/18 vaccines could provide over 75% protection against invasive cervical cancer. While an encouraging finding, it is important to note that this data is largely the product of a mathematical estimate, and it does not speak to the challenges of implementing a large-scale vaccination program in India or elsewhere.
  

Caplan on college meningococcus vaccine requirements

Last week, MSNBC.com published a story titled, "Killer at college: Meningitis threatens students; Mandatory vaccine for deadly bacterial disease sparks debate." The story provides a detailed account of the threat posed by bacterial meningitis on college campuses and efforts by many states to require vaccination for college freshmen (or a signed waiver declining the vaccine). More information about meningococcal vaccination is available from this CDC website, and details about SanofiPasteur's Menactra (the vaccine recommended for adolescents) is available here.

In response to this story, Penn's Art Caplan wrote a commentary for MSNBC.com that was posted last Thursday: "Students' meningitis shots should be required." He writes, in part,

"Americans do love choice. But they also hate to lose a child, a sister or a granddaughter. Sometimes choice ought to yield to common sense and evidence. We ought [to] be doing all we can to get young people vaccinated against meningitis and to make sure that the costs of doing so are covered."

The importance of this issue was illustrated by tragic news on our own campus Sunday of the death of a Penn sophomore from bacterial meningitis. Here is coverage from The Daily Pennsylvanian and The Philadelphia Inquirer.

At Penn, all students living in on-campus dormitories are required to be vaccinated with Menactra or sign this waiver citing medical contraindications or religious objections to the vaccine. (This policy is in accordance with a 2002 Pennsylvania law.)

News reports note that the victim lived off-campus during the current school year, but nearly all Penn students live on-campus during their freshman year, making it likely that the vaccination requirement applied to the student one year ago. No information has been made public regarding her vaccination status.

HPV: Is adolescent consent sufficient?; Data on vaccine effectiveness post-infection

The August issue of Pediatrics included a commentary related to HPV vaccine ethics and policy that is worth noting, even several weeks after its publication. Ruth Farrell and Ellen Rome from the Cleveland Clinic offer a well-reasoned argument in favor of adolescent consent being sufficient for HPV vaccination in their commentary, "Adolescents' Access and Consent to the Human Papillomavirus Vaccine: A Critical Aspect for Immunization Success." (free extract).

The authors argue that HPV vaccination could reasonably be given the same status as other reproductive health matters among teenagers, for which parental consent is not required. They outline some of the reasons why teenagers might seek the vaccine without parental involvement or knowledge and note the missed opportunity that would occur if physicians postpone discussion of the vaccine or vaccination itself until a future visit with a parent present. They write:

"Lack of parental authorization, whether because the adolescent's mother or father may not be reachable or the adolescent truly seeks confidentiality in immunization, should not overshadow the chance to initiate or continue immunization administration. By the time the adolescent returns for health care (with or without a parent), she may have initiated sexual activity, with the vaccine losing its maximum potential efficacy."

While these authors are not the first to suggest waiving parental consent for HPV vaccination, the publication of their argument in the nation's premier journal for pediatric medicine is likely to influence the policy discussion in the coming months.

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Data that could be seen as supporting Farrell and Rome's argument could be found in an August issue of JAMA. There, Allan Hildesheim and colleagues explore the "Effect of Human Papillomavirus 16/18 L1 Viruslike Particle Vaccine Among Young Women With Preexisting Infection" (In layman's terms, "Does Gardasil Help if a Woman Already Has HPV?") At the risk of oversimplifying a nuanced study, the answer is an unsurprising "NO!" This finding confirms what had long been known about the vaccine (and the reason why vaccination is recommended for 11-12 year old girls prior to first sexual contact).

An accompanying editorial "HPV Vaccines--Prophylactic, Not Therapeutic" reinforces this point and explains how the vaccine's lack of therapeutic action shaped the ACIP recommendations.

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Finally, a new issue of HPV Today was released earlier this summer. Included in it are status reports on HPV vaccination in the U.S. and worldwide and a short paper explaining why HPV subtype replacement is unlikely to occur as a result of widespread vaccination with Gardasil or Cervarix.