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It affects over 130 million infants and children, is responsible for tens of thousands of hospitalizations, and causes over 800,000 deaths per year worldwide. These statistics reported by the Centers for Disease Control and Prevention are astounding, yet very few of us are worried about contracting rotavirus, named after its wheel-like shape. One reason for ours unawareness is that its symptoms, diarrhea and vomiting, are part of normal childhood disease; in fact, it is estimated that most people are infected with rotavirus by age five. The National Institutes of Health report, surprisingly, that in the United States alone, about 55,000 to 100,000 children are hospitalized due to dehydration and 20 to 100 die from this virus. In developing countries the death rate is over 8000 times that of the US (Figure 1). Actual infection rates between developed and developing countries do not differ, rather it is the health care treatment available that is responsible for the difference between the number of deaths. Once it was recognized that rotavirus was a worldwide concern, the World Health Organization gave high priority to developing a vaccine.
Researches observed that a first bout with diarrhea caused by rotavirus was the most severe, and following re-infections decreased in severity. This indicated that immunity could be obtained by exposure, highly suggesting a vaccine could prevent against disease. A vaccine, RRV-TV, was developed to protect against the four most prominent strain of rotavirus in the United States by combining three genetically altered human rotavirus and one strain of a monkey rotavirus. The vaccine was tested, and determined safe and effective with mild fever being the only side effect reported. In August of 1998 the vaccine was licensed in the United States. The World Health Organization estimated that the vaccine could save the lives of 1 million children every year. In July of 1999, The Center for Disease Control and Prevention reported about 100 cases of intussusception, bowel obstruction, associated with the of 2 million doses of vaccine administered. Two children died, and about 50 need surgery. The manufactures of the vaccine, Wyeth-Ayerst Laboratories, voluntarily stopped production of the vaccine.
While there was no statistical significance in the number of cases of intussusception reported in trials, nor has a direct link between intussusception and the vaccine been proven, the vaccine was taken off the market. In the United States and other industrialized countries, rotavirus is mainly a cost concern rather than a health concern since rotavirus does not pose a serious threat to survival.
In developing countries the story is more involved- about 2,000 children die each and every day from rotavirus complications. The need for the immunization has become a necessity, yet the US is holding back production of this vital vaccine. Let’s say that the given statistics are accurate. There is one death for every 1 million children vaccinated and the vaccine is its reported 98% effective. If all the children in the world, about 1 billion, were vaccinated, potentially there would be 1,000 deaths. Not to say that those deaths wouldn’t be tragic, but that is a considerable amount less than the 800,000 children that die a year now.
The values and needs of the countries involved need to be assessed. While the US and other countries hold individual rights as most mportant, delaying the vaccine might be in their best interest, whereas other countries are more communal. People in underdeveloped countries may be willing to take the chance that they or their children could suffer from intussusception to have the opportunity of acquiring immunity to protect themselves as well as not passing the infection on to other in the community. With that in mind, is it possible that the vaccine should be available to other countries as long as they are informed of the possible risks?
There are also other complications with the design of the vaccine. The vaccine was designed based on the four strains found in the US. There are other strains that have been found in India and Africa. While efficacy trials have been done in Venezuela and shown the vaccine to be effective, further studies still need to be done in different regions of the world. Also, the vaccine is administered in three doses, something that is not very plausible in developing countries due to the lack of medical management and economics. Little is known if the same level of protection is possible with one dose, the way the vaccine would be administered in other countries. As with all vaccines when they are new, developing countries are unable to afford a $10-$30 vaccine when $20 or less is spent on each person per year for health care, and it is the government who ultimately decides how to use the money.
As seen here, biological, medical, scientific, economic, ethnic, and ethical implications need to be taken into consideration and addressed when dealing with global health concerns.
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