rotovirus vaccine Recalled to soon ? they gonna bring it back?

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• Rotavirus vaccine: Recalled too soon?

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   > See Next Week | Rotavirus vaccine: Recalled too soon?

by In 1999, the Centers for Disease Control and Prevention

(CDC) recommended that the rotavirus vaccine be pulled from the market amid

fears that it could cause bowel blockage in young children (though rarely).

But new research from the National Institutes of Health (NIH) questions that

link, and suggests that the potentially life-saving vaccination may have been

pulled prematurely.Rotaviruses are the leading cause of severe dehydration

and diarrhea among infants and young children in the United States. The

American Academy of Pediatrics (AAP) says rotavirus infection accounts for

50,000 hospitalizations and between 20 and 40 deaths among children and

adults each year.In August 1998, the FDA licensed the rotavirus vaccine,

called Rotashield, in the United States for the prevention of severe diarrhea

caused by the rotavirus. Beginning in October of that year, an estimated 1.5

million infants received the vaccine.In October 1999, after receiving 15

reports of intestinal blockage (called intussusception) among children who

had recently received the Rotashield vaccine, the CDC recommended that the

vaccine be withdrawn from the market pending an investigation. Full-blown

cases of intussusception are characterized by severe, intermittent abdominal

discomfort, alternating with periods of comfort, and sometimes blood and

mucus in the stools.Researchers at the NIH analyzed hospital discharge

records from ten states between 1993 and 1999, and examined the hospital

records of children under a year old who were admitted for intestinal

blockage. During the period when Rotashield was available, the researchers

found no evidence of increased hospital admissions due to intestinal

blockage, and actually noted a decrease in such admissions, according to

results published in the October 13 issue of The Lancet. Three new CDC

studies validate these findings, similarly indicating that the risks of

intestinal blockage are much lower than previously believed.What you can do

Although Rotashield is still licensed by the Food and Drug Administration,

pediatricians are not giving it to their patients. More research is needed to

confirm its safety, says study author Lone Simonsen, an epidemiologist with

the National Institutes of Allergy and Infectious Diseases at the NIH. " We

want to keep the door open and learn all we can, " she says, " for the sake of

a fair evaluation of the Rotashield vaccine, and for the sake of any future

oral vaccines that may find a very small intussusception risk to be a very

large obstacle for licensing and use. " Despite the recent findings, Rotashield

manufacturer Wyeth Laboratories says it has no plans to resume production of

the vaccine. >

                                                   

                       

                                                    

                       

 

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