FDA Approves Rotavirus Vaccine

Infection with rotavirus is a leading cause of severe diarrhea in infants and young children in the United States and worldwide. A search for a vaccine for this disease has borne fruit with the approval of this new vaccine.

The Food and Drug Administration (FDA) announced the approval of RotaTeq™, a live, oral, vaccine for use in preventing rotavirus gastroenteritis in infants. It is the only vaccine approved in the United States that can help protect against rotavirus, a viral infection that may cause diarrhea, vomiting, fever, and dehydration.

"This vaccine gives health care providers an important new tool that can effectively prevent an illness that affects almost all children within the first few years of life," said Jesse L. Goodman, MD, MPH, director of FDA’s Center for Biologics Evaluation and Research.

The Centers for Disease Control and Prevention (CDC) has estimated that rotavirus infection results in approximately 55,000 hospitalizations annually of infants and young children in this country. Death from rotavirus is rare in the United States. However, in developing countries, rotavirus gastroenteritis has been estimated to cause up to several hundred thousand deaths annually in infants and young children.

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