The U.S. Food and Drug Administration has revised its recommendations for rotavirus vaccines and has determined that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.
In March, FDA recommended temporary suspension of Rotarix after learning that DNA material from porcine circovirus type 1 (PCV1) was present in the vaccine.
The agency reached its decision to recommend resumed use of Rotarix based on a careful evaluation of information from laboratory results from the manufacturers and the FDA’s own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts.
Rotavirus vaccines are given by mouth to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration. Rotavirus disease causes the deaths of more than 500,000 infants around the world each year, primarily in low- and middle-income countries. Before the introduction of vaccination, the disease caused more than 50,000 hospitalizations and several dozen deaths in the U.S. each year.
More information for parents and caregivers: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205547.htm
More information for health care providers: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205548.htm