No extra bowel problem risk with Merck vaccine: CDC

Thu Mar 15, 2007 9:14pm GMT
 
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NEW YORK (Reuters) - The U.S. Centers for Disease Control and Prevention (CDC) said on Thursday Merck & Co. Inc.'s new vaccine against the rotavirus posed no elevated risk of a serious bowel condition in infants.

The CDC said after reviewing safety data that reported cases of the serious condition known as intussusception after the vaccine was used did not exceed the normal number of expected cases.

The declaration removes a cloud hanging over the vaccine, called RotaTeq, since last month, when the Food and Drug Administration notified health-care providers and consumers about 28 cases of intussusception in infants after they received the vaccine.

Since then, the FDA, ACIP (The Advisory Committee on Immunization Practices) and CDC have concluded intussusception reports have not exceeded the number expected without vaccination and that the vaccine does not appear to be associated with intussusception, the CDC said.

"The data we have reviewed are reassuring, and we continue to recommend the RotaTeq vaccine," Anne Schuchat, director of CDC's National Center for Immunization and Respiratory Diseases, said in a statement.

"However, we will continue to carefully monitor reports of possible adverse effects associated with the vaccine and will take appropriate action if there proves to be a problem in the future."

Intussusception is a potentially life-threatening condition that occurs when the intestine gets blocked or twisted and one portion telescopes into a nearby portion, causing an intestinal obstruction and intense abdominal pain.

Most infants who are treated within 24 hours recover completely, but a delay in treatment can result in serious complications, including tissue damage, perforation of the bowel and death.

The bowel problem spurred the recall in 1999 of Wyeth's RotaShield vaccine against rotavirus.

The rotavirus causes serious diarrhea and is a leading cause of hospitalization for infants.

Each year in the United States, rotavirus is responsible for more than 400,000 doctor visits, more than 200,000 emergency room visits and 55,000 to 70,000 hospitalizations, the CDC said.

 

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