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.

Research updates: meningococcus, dengue, and cocaine(!?!)

While we were away, there's been news on several fronts related to research on new vaccine candidates, some much farther along than others:

• Meningococcus -- The Jan. 9-16 issue of JAMA reported positive Phase II clinical trial data for a new meningococcal vaccine for infants manufactured by Novartis. The vaccine, called Menveo, would be the first available for infants, a population not covered by two meningococcal vaccines currently licensed in the U.S. Phase III trials are underway. An editorial on the results accompanied the paper in JAMA. Here's the Novartis Press Release and coverage from USA Today and HealthDay News.

• Cocaine -- There's been a great deal of attention to stories like this one on preliminary research at Baylor University that aims to develop what its (media-savvy) researchers generously describe as a "cocaine vaccine." Similar to reports of a "nicotine vaccine" that made the rounds a few years back, more interesting than speculation about a therapy that is many, many years away (if ever) is the continued broadening of the meaning of 'vaccine' by researchers working on just about any strategy that involves the immune system. Nevertheless, the media strategy worked, as one newspaper headline (originally in the Houston Chronicle) proclaims, "Researchers develop cocaine vaccine." Time magazine was on top of the story as well, publishing a news story as well as a bioethicist Q&A with the rather sweeping headline, "The Ethics of Vaccination."
  

• Dengue -- This commentary in the Jan. 9-16 issue of JAMA co-authored by NIAID Director Anthony Fauci reviews public health risks related to dengue and hemorrhagic fever in the United States. The essay reviews the progress and unanswered questions related to dengue vaccine development.
  

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.

Also in the news: new meningitis vaccine?; ethics of clinical trials

Two other odds-and-ends appearing in our inbox this week:

-- An AP story from late last week proclaims, "New meningitis shot could end fatal epidemics." Not surprisingly, "could" is very much the key word in that headline. As the story points out, the positive data being announced comes from a clinical trial of only 600 toddlers in Africa, and the successful introduction of the vaccine candidate is, at best, years away. More depressing, but no doubt accurate, is this point from the story:

"Even if the new vaccine becomes available, experts think there will be a lag of about 15 years before the majority of Africa’s at-risk population can be vaccinated."

Of course, this 'lag' is present for the introduction of any new vaccine in the developing world, often (as is the case for rotavirus and HPV vaccines) the parts of the world where the greatest vaccine-related benefit is possible.

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-- Speaking of vaccine research and testing in the developing word, the June 21 issue of Vaccine includes a paper titled, "Ethical considerations related to the provision of care and treatment in vaccine trials." (subscription required). Written by Daniel Tarantola, Ruth Macklin, and colleagues, the paper summarizes a meeting exploring the long-disputed question of the type and level of care due to research subjects in the developing world (where the standard of care is typically quite different from the home countries of research sponsors.)

Those looking for a clear recommendation will not find it here. The authors recommend "a structured approach" to decision-making, meaning, "a consultative process with trial communities and other stakeholders in research [that] will ensure that the needs and legitimate expectations of trial participants are appropriately met, obligations towards them are delivered and, as a result, ethical research is facilitated in the interest of public health."

News that 'low-cost vaccine' may not be an oxymoron

The Financial Times has this story titled "Low-cost meningitis vaccine may be available in three years." Good news indeed, but if we read all the way to the third-from-last sentence in the story, we learn that the only 'news' is that phase I trial data for this vaccine candidate is positive, making the three-year prediction an optimistic (some might say best-case) scenario. Here's the press release from the Meningitis Vaccine Project, a Gates-funded consortium spearheaded by WHO and others.

Of course, anyone is free to issue a press releasing trumpeting the importance of their work, but it's an open question whether phase I trial results truly merit the media coverage they often receive. Given the years of additional research necessary and the high likelihood of failure along the way, such reports may only add to public confusion amid an already complex vaccine landscape. For this reason, you won't often see coverage of phase I vaccine trials here.

Why the exception this time? This passage in the FT story stood out:

"...The initiative would mark the first time a vaccine had been developed for and within the developing world, with an agreed low-cost price that was sustainable and profit-making for the manufacturer. It also marks a ground-breaking approach to developing the new medicines cheaply by using researchers from poorer countries, at a time when large western pharmaceutical groups claim it can cost $800m or more to produce drugs and vaccines.

By contrast, he said the Meningitis Vaccine Project was on budget to meet its objectives of developing, licensing, testing and introducing the vaccine in the period 2001-2011 for just $70m."

If this effort is ultimately successful (it's far too early to tell), it would mark a tremendous achievement for vaccines for the developing world.

There's no dispute that new vaccines against rotavirus and HPV would most greatly benefit developing countries, where the number of deaths caused by the viruses dwarf those in the U.S. and Europe. Sadly, however, the prices of these vaccines will limit their availability greatest in the parts of the world needing them most. With 2.1 million vaccine-preventable annual deaths (most of which involve much older and much cheaper vaccines), funding a new rotavirus series with a sticker price of $187.50/child would seem to face any number of challenges.