Rotarix Vaccine: Update to Clinicians and Public Health Professionals

Rotarix Vaccine: Update to Clinicians and Public Health Professionals
Audience: Pediatric and family practice healthcare professionals, public health professionals
[UPDATED 05/16/2010] FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. Based on a careful evaluation of laboratory results from the manufacturers and its own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, the agency is revising its recommendation to temporarily suspend use of the Rotarix vaccine. FDA has also determined that RotaTeq vaccine should remain in use.
In its decision, FDA considered that both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of recipients. FDA has no evidence that either porcine circovirus (PCV1 or PCV2) poses a safety risk in humans, and notes that neither is known to cause infection or illness in humans. The benefits of the vaccines are substantial, and include prevention of hospitalization for severe rotavirus disease in the United States and of death in other parts of the world. he benefits outweigh the risk, which is theoretical. FDA and the manufacturers will continue to investigate the findings of PCV in rotavirus vaccines and will evaluate information from ongoing testing by FDA and the manufacturers.
Read the complete MedWatch 2010 Safety summary, including the original March 22 notice and links to the updates for Healthcare Professionals and for Parents/Caregivers, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205640.htm