Rotavirus Vaccine: Costs and Benefits

Howard Markel, MD, PhD

Disclosures

May 25, 2006

At this late date, one hardly needs to remind pediatricians or other pediatric healthcare providers that rotavirus is, perhaps, the most common cause of diarrhea in the world. No minor footnote to a medical textbook, rotavirus is responsible for more than 140 million episodes of diarrhea each year and anywhere from 500,000 to 1,000,000 deaths worldwide. It also accounts for one third of hospitalizations for diarrhea in the world today.

In the United States alone, there are more than 3.5 million cases annually, 200,000 visits to emergency rooms, 400,000 trips to doctors' offices -- and 50,000 of these cases are severe enough to warrant hospitalization. Each winter, often beginning in Southern California in December and sweeping across the nation to the Eastern seaboard by April, every practicing American pediatrician sees dozens -- if not hundreds -- of cases of miserable little kids with "the runs," accompanied by exhausted parents searching for an end to the foul-smelling diarrheal river they've been desperately trying to dam.

Fortunately, the United States is blessed with superb hospitals and medical care that allow for the swift administration of intravenous fluid. Nevertheless, this crafty gastrointestinal virus still manages to kill about 100 American children a year who do not get to the hospital in time.

Where rotavirus is especially relentless -- thanks to its dehydrating power, particularly when it comes to small children and infants - is in those poorer parts of the world where access to medical care (and intravenous fluids or oral rehydration solution) is sparse. As a result, rotavirus has the notorious distinction as one of the world's deadliest diseases.

So it really was earth-shaking news when, on February 3, the US Food and Drug Administration approved an effective oral vaccine against rotavirus. It is a live vaccine intended to be administered to infants at the same time they receive immunizations for diphtheria, pertussis, and tetanus. This pentavalent vaccine is based on a bovine strain WC3, which contains 5 human-bovine reassortment viruses. Although it requires 3 doses, with at least a month between doses, to achieve protection, it has been demonstrated to almost entirely prevent the life-threatening bouts of diarrhea and vomiting that the rotavirus invariably inspires.

In the weeks to come, the Advisory Committee on Immunization Practices, the body of independent vaccine researchers who meet under the aegis of the Centers for Disease Control and Prevention, will vote on adding this vaccine to the routine immunization schedule at 2, 4, and 6 months of age.

But there's a troubling catch to this truly remarkable scientific advance: a cost of almost $190 for a series of 3 oral doses - which makes it one of the most expensive vaccines sold. Parenthetically, another effective rotavirus vaccine has also been developed -- a monovalent vaccine derived from the most common human rotavirus strain, G1P[8]. It, too, is likely to be rather expensive, but at this writing, the manufacturer has not yet applied for approval in the United States, although it is approved for use in 30 other nations.

Nevertheless, 2 recent and large-scale vaccine trials, published in The New England Journal of Medicine,[1,2,3] have concluded that both vaccines really do work. So although the widespread administration of these vaccines to American children, or to those living in other Westernized and wealthy nations -- would certainly be a wise investment in terms of lost work hours due to parents taking care of their ill children and healthcare-related expenses, the real question is, What do we do about the millions of children living in the poorer nations of the world who need this life-saving vaccine the most and, sadly, are least likely to get it?

Although several philanthropic groups and public health agencies, most notably the Bill and Melinda Gates Foundation, the World Health Organization, and the Global Alliance for Vaccines and Immunization, are eager to get these powerful vaccines to those who need them most, the money is simply not there. For example, the current global vaccine initiative being funded primarily by the Gates Foundation is hard-pressed to deliver worldwide a vaccine against 5 other major killers of children, and that product costs only $3.50 per child.

The bottom line is that effective vaccines remain one of the greatest achievements in the history of medicine and public health. They are a greater good that protect us all. It is essential, therefore, that those making and profiting from these remarkable products -- working in concert with national governments, philanthropies, nongovernmental organizations, and global health agencies -- develop a plan and secure the resources that can make these vaccines available to those who need them most.

How will successive generations judge us? One measure might be how successful we are today in introducing these rotavirus vaccines into the routine immunization schedules of every child in the world.

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