Updated May 14, 2010
Rotavirus causes severe diarrhea and dehydration in young infants. There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. Each of these vaccines is given by mouth in a series of doses during the first year of life.
Within the last two months, 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.
Are the rotavirus vaccines safe to give to my child?
Yes, both vaccines have a successful track record of safety and effectiveness. FDA has evaluated laboratory results from testing performed by the manufacturers and in its own laboratories. Based on a careful evaluation of these results, a thorough review of the scientific literature, and input from scientific and public health experts, FDA has no evidence that either PCV1 or PCV2 poses a safety risk. Neither PCV1 nor PCV2 is known to cause infection or illness in people. The benefits of the vaccines for infants are substantial, and include prevention of hospitalization for severe rotavirus disease in the U.S. The patient information for Rotarix and RotaTeq is posted on FDA’s web site.
My child received the rotavirus vaccine. Should I be worried?
No. Both vaccines have strong safety records, including clinical studies involving tens of thousands of patients and millions of recipients following approval. Neither PCV1 nor PCV 2 is known to cause infection or illness in people. Children who received Rotarix or RotaTeq vaccines need no additional medical follow-up.
Was FDA's March 22, 2010, recommendation to temporarily suspend use of the vaccine due to safety concerns?
No. Based on what we know, the presence of PCV1 in Rotarix and DNA from PCV1 and PCV2 in RotaTeq is not a safety issue. Neither PCV1 nor PCV2 is known to cause infection or illness in people. FDA and the manufacturers are continuing to investigate and evaluate these findings.
How will I find out more?
FDA will keep the public updated at www.fda.gov.