Vaccines, Blood & Biologics
Update on Rotavirus Vaccine
In March 2010, FDA became aware of the presence PCV1 in Rotarix and DNA from PCV1 and PCV2 in RotaTeq. These viruses are not known to cause any infection or illness in people. Based on a careful review of a variety of scientific information, FDA has determined it is appropriate for clinicians and public health professionals in the United States to use these vaccines. All available evidence supports the safety and effectiveness of Rotarix and RotaTeq, which have been extensively studied, both before and after approval.
This web page provides additional background information and Questions and Answers for patients and providers.
About Rotavirus, PCV, and the Rotavirus Vaccines:
FDA Actions
Updated: December 28, 2010Update: Information on Rotarix - Labeling Revision Pertaining to Intussusception
Questions and Answers, September 22, 2010Update on Recommendations for the Use of Rotavirus Vaccines
Updated: May 14, 2010FDA Revises Recommendations for Rotavirus Vaccines
Updated: May 14, 2010Background on PCV
Updated: May 14, 2010Information for Parents and Caregivers
Updated: May 14, 2010Additional Information for Healthcare Providers and Public Health Professionals
Updated: May 14, 2010Background on Study Results of U.S. Academic Researchers
April 8, 2010Background on Viral Vaccine Development
March 22, 2010Background on Rotavirus
March 22, 2010Background on Rotavirus Vaccines
March 22, 2010
Additional Background Information
Early Communication on Rotarix Vaccine
March 22, 2010Detection of DNA from PCV1 in Rotarix
March 22, 2010Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk
FDA News Release, Posted: 3/22/2010BBB - Rotavirus RotaTeq Merck & Co, Inc Rotavirus Vaccination (Centers for Disease Control and Prevention) Centers for Disease Control and Prevention Vaccines and Related Biological Products Advisory Committee Meeting Background Material
May 6, 2010