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Merck RotaTeq May Be Contraindicated for Infants with SCID

Posted Feb 03 2010 12:00am

Rotateq-logo Managing Editor's Note: Kudos to The Wall Street Journal for sharing this information about a live virus vaccine infecting a once unacknowledged population, so that American parents and physicians can make informed decisions for their infants and patients. About the last line, that RotaVirus "...causes more than 500,000 deaths from dehydration among young children world-wide, mostly in countries were vaccination isn't common." Is it lack of vaccination or lack of clean water, proper nutrition and access to medical care that leads to these deaths?

By Jennifer Corbett Dooren

Doctors said infants with a rare immune deficiency can be sickened with a gastrointestinal illness after being vaccinated with a rotavirus vaccine.
A report in this week's New England Journal of Medicine discusses the cases of three infants with severe combined immunodeficiency, or SCID, who developed dehydration and diarrhea after receiving a first or second dose of Rotateq, a vaccine made by Merck & Co.

It wasn't known at the time the babies were vaccinated that they had SCID, which is a rare immune-system disorder. Studies of the infants showed they developed rotavirus related to the vaccine and didn't get the virus from another source.

Rotateq was approved for use in the U.S. in 2006. GlaxoSmithKline PLC's competitor vaccine, Rotarix was approved in 2008.

Rotateq's label was updated last month to state that infants with severe combined immunodeficiency shouldn't receive the vaccine.

But one of the authors of the report, Stuart L. Abramson, explained that infants with SCID aren't always diagnosed with the disorder before receiving the first dose of a rotavirus vaccine, typically at two months of age.

Dr. Abramson, a doctor at Texas Children's Hospital and an associate pediatrics professor at Baylor College of Medicine, said doctors should be cautious before vaccinating infants who have recurrent, hard-to-treat infections. Such infections can suggest an infant has an immune system disorder. "We want health-care providers to be attuned to the possibility that their infant may have an immune deficiency," he said.
Rotavirus vaccines are now given to most U.S. infants to protect against rotavirus, a common gastrointestinal illness in children that can cause severe diarrhea and vomiting. Studies show the vaccines have sharply cut the rates of rotavirus in infants and toddlers.

Before the vaccines were approved, the Food and Drug Administration had estimated that up to 70,000 infants and toddlers in the U.S. were hospitalized annually for dehydration and other complications from rotavirus; about two dozen babies died.

Rotavirus is the leading cause of severe childhood diarrhea and it causes more than 500,000 deaths from dehydration among young children world-wide, mostly in countries were vaccination isn't common.

The vaccines are designed to offer protection against rotavirus for two years. After that, most children are old enough to withstand rotavirus illnesses with few complications.

Funding for the research involving the three infants was paid from grant money given by the National Institutes of Health. One of the papers authors, Mary K. Estes, also of Baylor College of Medicine, reported receiving lecture fees from Merck.

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