FDA Warns Against Using Rotavirus Vaccine Rotarix

The Scoop

A new vaccine warning from the Food and Drug Administration (FDA) urges pediatricians and other healthcare providers to temporarily discontinue use of the Rotarix rotavirus vaccine until further testing can confirm the vaccine's safety. The FDA's warning, issued March 22, 2010, came after researchers turned up evidence that Rotarix contains components of a pig virus called porcine circovirus 1 (PCV1). The virus is not known to cause illness in adults or children vaccinated with Rotarix, but FDA officials decided to err on the side of caution until additional information can be obtained.

According to Margaret A. Hamburg, FDA Commissioner for Food and Drugs, "There is no evidence at this time that there is a safety concern. FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation. We will keep the public and the clinical community updated on our findings.”

Rotavirus causes severe diarrhea and dehydration and is thought to cause more than 500,000 deaths in infants worldwide each year, primarily in low- and middle-income countries. Before the introduction of a rotavirus vaccine (RotaTeq) in the US in 2006, the disease caused an estimated 50,000 hospitalizations and several dozen deaths each year. Rotarix was introduced in 2008.

The FDA expects to make updated recommendations in four to six weeks.

For Baby

Concerned? Your doctor or nurse should know which vaccine your child received. RotaTeq was licensed in 2006, and Rotarix was licensed in 2008. The majority of children in the US vaccinated against rotavirus received RotaTeq—a vaccine made using different materials from Rotarix (there is no evidence that PCV1 is present in RotaTeq). According to FDA estimates, about one million US children have received Rotarix since 2008. Rotavirus vaccines are typically administered at Baby's 2-, 4-, and possibly 6-month checkups.