©iStockphoto.com/Mike_Kiev
©iStockphoto.com/Mike_Kiev
by Amy Spangler
March 31, 2010
For parents concerned about vaccine safety, the news just got worse. The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have announced a temporary suspension of the rotavirus vaccine, Rotarix.
Manufactured by GlaxoSmithKline, Rotarix prevents rotavirus infection, the most common cause of severe diarrhea and dehydration in children. The FDA recently learned that fragments of an unrelated virus were found in Rotarix. According to the FDA, “there is no evidence at this time that this finding poses a safety risk.” However, as a precautionary measure, the FDA and the CDC have suspended use of the vaccine pending further investigation. These timely actions by two respected government agencies suggest that vaccine safety is indeed a top priority and that every effort is being made to ensure that children receive the safest vaccines available.
Before the rotavirus vaccine was introduced in the United States (U.S.) in 2006, approximately 55,000 U.S. children were hospitalized each year with diarrhea due to the virus. Worldwide, more than half a million children die each year from rotavirus infection. The vaccine is administered in three doses generally given at 2, 4, and 6 months of age. Currently there are two types of rotavirus vaccines, RotoTeq and Rotarix. No virus fragments have been found in RotoTeq, the vaccine most commonly used in the U.S. While experts are carefully examining both vaccines, the virus fragments found in Rotarix do not cause disease. The fragments were found because new technology allows researchers to see things they couldn’t see before. So far, there have been no reports of illness.
Parents who are unsure about whether their baby received the Rotarix rotavirus vaccine or who have questions about the safety of the vaccine are urged to talk with their baby’s doctor.