The FDA’s Warning About the Rotavirus Vaccine, RotaTeq

What is Rotavirus?

According to AskDrSears.com, Rotavirus, or RSV, is the number one cause of diarrhea in infants. It can also be accompanied by a fever and vomiting. It is highly contagious, lasts 3 to 8 days, and effects almost all children by their third birthday. In rare cases, fluid loss associated with Rotavirus leads to extreme dehydration requiring hospitalization.

Since it is passed through the feces, it tends to be a greater health threat in areas lacking clean water or adequate sanitation, causing approximately 100 deaths each year in the United States, but approximately 600,000 deaths worldwide. ( source link )

Most children will only need adequate rest and lots of fluids to fully recover.

The First Rotavirus Vaccine is Recalled

In 1998, vaccine manufacturer Wyeth released a new vaccine against Rotavirus called RotaShield. Aside from the usual side effects seen in vaccinations, RotaShield became linked to an alarming condition called instussception, which is a “blockage or twisting of the intestines” that sometimes requires surgery and can be fatal. After 76 reported cases in less than a year, the CDC recommended postponing the vaccine, and it was recalled. ( source link )

Merck’s RotaTeq Vaccine Emerges

Pharmaceutical giant Merck and Co., Inc. introduced a brand new vaccine aimed at Rotavirus which was approved in 2006. Initial clinical trials showed no relationship between the vaccine and an increased risk of intussusception, but after its release, the reports began coming in.

Between June 2006 and June 2007, 80 cases of intussusception after administration of RotaTeq have been reported, 4 more than the number that inspired the recall of RotaShield. ( Source Link )

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The FDA Issues a Warning to Parents

After the first 28 reported cases of intussusception following administration of RotaTeq, the FDA issued a statement asking parents to watch their children carefully for signs of intussusception and report any confirmed cases. The statement, released on February 13, 2007, said in part:

“The Food and Drug Administration (FDA) is notifying health care providers and consumers about 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (trade name RotaTeq), manufactured by Merck and Co., Inc. Intussusception is a serious and potentially life-threatening condition that occurs when the intestine gets blocked or twisted. One portion of the intestine telescopes into a nearby portion, causing the intestinal obstruction. The most common site is where the small intestine joins the large intestine.

Intussusception can occur spontaneously in the absence of vaccination. Of the reported 28 cases of intussusception, the number that may have been caused by the vaccine, or occurred by coincidence, is unknown.

FDA is issuing this notification both to encourage the reporting of any additional cases of intussusception that may have occurred or occur in the future after administration of RotaTeq, and to remind people that intussusception is a potential complication of RotaTeq….

Parents should contact their child’s doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception. It is important to contact the child’s doctor if there are any questions or if the child has any of these symptoms at any time after vaccination, even if it has been several weeks since the last vaccine dose.”

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(Exerpt from the FDA’s official statement)

This statement points out a critical component of determing not only the safety of Rotateq, but all vaccines in general: The bulk of safety testing is done after a vaccine’s release. At this point, it is up to parents to report adervse reactions, because formal studies are not done beyond the few required to release a vaccine to the public in the first place.

Additional Side Effects of RotaTeq

In addition to intussusception, Merck’s package insert lists the following potential side effects or adverse reactions to their Rotavirus vaccine:

Vomiting

Diarrhea

Irritability

Otitis media

Nasopharyngitis

Bronchospasm

Bronchiolitis

Gastroenteritis

Pneumonia

Fever

Urinary Tract Infection

Hematochezia (bloody stools)

Seizures

Intussusception

Death or SIDS

Note that diarrhea is listed in the package insert as a common side effect of a vaccine aimed at reducing infant diarrhea.

Between June 2006 and June 2007, 647 adverse reactions were reported to the government’s Vaccine Adverse Event Reporting System ( source link ).

However, it is difficult to pinpoint whether RotaTeq is the sole cause of these reactions, since it is frequently administered along with other vaccines.