FDA Issues Notice On RotaTeq Rotavirus Vaccine

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Main Category: Immune System / Vaccines
Also Included In: GastroIntestinal / Gastroenterology;  Pediatrics / Children's Health;  Pharma Industry / Biotech Industry
Article Date: 15 Feb 2007 - 0:00 PST

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The FDA has issued a public health notice to health professionals and consumers about the rotavirus vaccine RotaTeq.

It has received 28 reports on infants getting intussusception after being vaccinated with RotaTeq (Live, Oral, Pentavalent vaccine against Rotavirus) since the vaccine was licensed in February last year.

The vaccine prevents rotavirus gastroenteritis, the major cause of diarrhea and vomiting in young children worldwide. The infection is highly contagious and can cause severe dehydration (loss of body fluids) and even death.

So far, 3.5 million doses of RotaTeq, which is manufactured by Merck, have been distributed in the United States, not all of which have been administered.

Intussusception is a serious life threatening condition where part of the bowel collapses into a neighbouring part, rather like when a section of a collapsible telescope pushes into another. This results in the bowel becoming blocked or twisted.It usually happens where the small intestine joins the large intestine.

The FDA says it is issuing the notice to remind people that intussusception is a potential complication of the RotaTeq vaccine, and to encourage them to report cases of intussusception so that the FDA and the Centers for Disease Control and Prevention (CDC) can assess the risks associated with the vaccine.

They would like US healthcare professionals and others to report any cases of this or other adverse events associated with RotaTeq to the Vaccine Adverse Events Reporting System (VAERS).

If your child has stomach pain, vomiting and diarrhea, there is blood in the child's stool or changes in bowel movements, these could be signs of intussusception and you should tell the doctor straight away.

The FDA says that intussusception can occur spontaneously in the absence of vaccination and they do not know whether any of the 28 reported cases were caused by RotaTeq or just coincidence.

Of the 28 cases reported so far, about half of them occurred within 21 days of vaccination and 16 of the infants had to have surgery. The other children were treated without surgery, using enemas. No deaths were reported.

Before it was licensed, RotaTeq was tested in a clinical trial involving 70,000 children, where half received the vaccine and half received a placebo. No significant increase of intussusception risk was found. For instance 6 cases occurred in the RotaTeq patients and 5 in the placebo group.

However, the FDA says that another rotavirus vaccine which is no longer available may have been the cause of the increase in cases of intussusception, which is why it is important to gather the post-marketing data from patients. Two post-marketing studies are also being conducted, one by the manufacturer of RotaTeq, Merck with 44,000 infants, and the other by the CDC Vaccine Safety Data Link, with 90,000 infants.

Click here for FDA safety information and adverse events reporting program (MedWatch).

Click here for Information on Rotavirus Infection (Encyclpedia of Child's Health).

Written by: Catharine Paddock
Writer: Medical News Today


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