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The Informed Parent

Rotavirus: An Oral Vaccine for Infants

by Shanna R. Cox, M.D., F.A.A.P.
Published on Dec. 10, 2007
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Rotavirus is the most common cause of severe diarrhea among infants and young children in the United States. Approximately seven percent of children with severe rotavirus infection require hospitalization. Many others miss several days of school which subsequently leads to parents missing many days of work.

While rotavirus infections will run a course and resolve, dehydration is a significant concern during the course of the disease. This is particularly true for infants who have little extra reserve to tolerate this illness. In addition, the virus is very contagious making daycare and preschool centers places of high risk during outbreaks.

Studies have demonstrated that it typically takes three separate episodes of rotavirus infection to achieve “immunity” from the illness. Because of the high level of transmissibility, levels of hospitalization, and missed school or work days, rotavirus is a true public health concern.

In 1998 the first vaccine against rotavirus was introduced into the market. However, it was removed after only one year. A rare gastrointestinal complication called intussusception was observed to occur at higher rates in patients who had received the vaccine. There was not an alternative vaccine available at that time. Development of an alternate product has taken several years to push through clinical trials and Food and Drug Administration approval.

As of early 2006 Rotateq was introduced. Rotateq is a live vaccine that is given orally to infants at two, four and six months. This three-dose regimen is meant to mimic the three exposures to the virus. This, in turn, should then convey an immunity to any severe level of the disease. This vaccine underwent vigorous testing because of the early withdrawal of its predecessor. In multiple large trials that were conducted internationally through the Rotavirus Efficacy and Safety Trial, rates of intussusception were not increased among those who had received the Rotateq vaccine.

There are a few other important facts to understand about the Rotateq vaccine. First, Rotateq is a live vaccine. This means that infants are essentially receiving a miniature dose of rotavirus each time they receive the vaccine. Consequently, there may be a slight fever, vomiting, or diarrhea that could follow the administration of the vaccine. Any of these side effects should be mild, or may not occur at all. But they are a possibility.

Currently, Rotateq is recommended as a three-dose protocol for infants only by the American Academy of Pediatrics and the Advisory Committee on Immunization Practices, a branch of the Center for Disease Control.




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