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Vaccine use temporarily suspended by the FDA

Transmission electron micrograph (TEM) of the morphology of intact rotavirus particles.
Transmission electron micrograph (TEM) of the morphology of intact rotavirus particles.Photo: CDC/Bryon Skinner, 1981

In a Health Alert, the Centers for Disease Control and Prevention (CDC) announced that the U.S. Food and Drug Administration (FDA) issued a recommendation to temporarily suspend the use of Rotarix, a GlaxoSmithKline vaccine for rotavirus.  The FDA discovered that DNA from porcine circovirus type 1 (PCV1) is present in the Rotarix vaccine.  This virus is not known to cause disease in humans, and there is no evidence to indicate any increased risk to patients who have received the vaccine.

In Tuscaloosa, and the West Central Alabama area, Rotarix and other vaccines are given orally to young infants in an effort to prevent rotavirus disease.  Rotavirus disease, and the resulting diarrhea and dehydration, is responsible for the worldwide death of more than 500,000 infants each year.  In the United States, it results in more than 50,000 hospitalizations and a few dozen deaths annually.

The Rotarix vaccine has a very good safety record with no unusual adverse effects and has been studied very closely, both before and after FDA approval.  GlaxoSmithKline self-reported the PCV1 finding last week, and all indications point to the PCV1 DNA being present since the early stages of the vaccine’s development.  However, the FDA is recommending that health practitioners in the United States suspend use of the vaccine, on a temporary basis, while the agency conducts studies.

Going forward, the FDA recommends that the RotaTeq vaccine, manufactured by Merck, be used for rotavirus immunization.  For any children who have received one dose of Rotarix, the recommendation is to complete the series with two doses of RotaTeq.  Because RotaTeq was licensed first, more children in the United States have been vaccinated with it.  It is made using a different process and preliminary studies have not shown the presence of PCV1 DNA.  Merck is working with the FDA to confirm these results.

Within the next four to six weeks, the FDA will convene an advisory committee to review the data and make recommendations.  Following the review, the FDA will make further recommendations on use of the two licensed rotavirus vaccines in the United States.

For additional online information, or information in your community, please consult one of the following:

FDA Update on the Rotarix Vaccine


List of contact information for County Health Departments in Alabama

Textbook of Bacteriology