Newer version of rotavirus vaccine called safe

Concerns about intussusception have not panned out.

By Victoria Stagg Elliott — Posted April 9, 2007

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The vaccine that provides protection against the rotavirus does not increase the chance of developing intussusception, according to a paper published in the March 16 Morbidity and Mortality Weekly Report.

"It's comforting that about 3.6 million doses have been distributed, and there's no evidence that there's a risk," said Joseph Bocchini, MD, chair of the American Academy of Pediatrics Committee on Infectious Diseases, describing the data on the intestinal disorder.

Public health and regulatory agencies have been closely monitoring reports of this possible side effect because the vaccine's original version, RotaShield, was removed from the market in 1999 for this reason.

In February, the Food and Drug Administration issued an advisory about RotaTeq, the more recent formulation, saying that it had received 28 postmarketing reports of intussusception after the administration of this vaccine. The advisory also encouraged reporting any more cases.

The MMWR paper found that the number of reported adverse events from when the vaccine was licensed in February of last year until Feb. 15 of this year did not exceed the expected background rate. The recommendation from the Centers for Disease Control and Prevention that it should be administered routinely at two months, four months and six months also remained unchanged.

"We continue to recommend the RotaTeq vaccine," said Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases. "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."

Merck & Co., the vaccine's manufacturer, also added information about these postmarketing reports to this immunization's label and pledged to continue working with the relevant vaccine safety monitoring agencies.

"Merck places public health and patient safety as our highest priorities," said Mark Feinberg, MD, PhD, the firm's vice president of policy, public health and medical affairs.

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