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New Rotavirus Vaccine Danger

Fda Warning, Rotavirus

The FDA is warning parents, Doctors and other’s who work with children about the dangerous side effects of the newest Rotavirus vaccine – Rotateq. Newly vaccinated infants have reportedly been admitted with life-threatening twisting of the intestines. This serious condition is intessusception and is the reason why the original rotavirus vaccine was pulled from the market years ago.

Rotavirus is a virus which generally causes diarrhea and upset stomach, more so in young children. It is estimated that everyone catches this at least once before the age of 5 and while the vast majority suffer no long lasting or serious complications as a result, a vaccine was made to potentially avoid this common childhood condition.

Rotateq – the new rotavirus vaccine was released last year by the very profitable pharmaceutical company Merck, has previously been thought to be much safer than the past version. Initial studies and trials of the vaccine were did not include any reports of increased intessusception after vaccine administration. Over 3.5 million doses of the new vaccine have been given to children since its release. The shot is injected in 3 times series when parents of young infants and toddlers consent to it at their pediatrician’s office. There have been reports of stomach condition as adverse reactions but none that have caused the FDA to look into it, until now. 28 cases of infants and toddlers needed intestinal surgery after receiving the Rotateq vaccine prompted the latest warning. While it is not yet enough to recall the vaccine and pull it off the shelves, it has got the CDC investigating it as well. There is a very small chance of intestinal twisting occurring on it’s own or for another reason but the fact that all these young children were recently vaccinating for rotavirus is a huge cause for concern and is more likely directly related.

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Another not-so-well known fact about the Rotateq shot is that it is a live vaccine. It is very possible to transmit rotavirus from a freshly vaccinated baby to those who are around them. Careful hand washing and other safety precautions should take place, especially after diaper changes as transmission from feces is high. The problem is that parents are often not told this after getting their child’s routine shots done and thus rotavirus is spread as a result of the very thing that was intended to help avoid the annoying condition. And that’s what it is in most cases, Rotavirus is an annoying sickness that involves diarrhea and stomach discomfort. The biggest risk is dehydration and that is what parents of children who have the messy virus should look out for. Children in child-care are more likely to catch the diarrhea bug, but it’s still not enough reason to choose the brand-new-not-so-tested vaccine.

Rota shield was the name of the first rotavirus vaccine developed by Wyeth and was recalled in 1999 after being attributed to intestinal twisting in young children. Many parents and pediatricians were skeptical when the newest version Rotateq came out, yet it’s been added to the recommended “childhood immunization schedule” despite not being adequately tested before its release. Anyone who’s experienced a few days of upset stomachs and messy diarrhea will attest to it being no fun, but it is manageable and almost always not life threatening in otherwise healthy children. Before the first vaccine came out, there wasn’t a huge concern about this condition; it was just a part of growing up for most in most families. It is estimated that at least 2.7 million children under the age of 5 will come down with rotavirus each year.

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For the actual FDA warning release, please see my first source cited below.

FDA, “Public Healthy Notification: Information on RotaTech and Intussusceptions” FDA

URL: http://www.fda.gov/cber/safety/phnrota021307.htm

ANDREW BRIDGES, “FDA warns of vaccine complications” Associated Press.

URL: http://www.businessweek.com/ap/financialnews/D8N90TRO0.htm