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.