[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.
FDA is recommending that healthcare professionals temporarily suspend the use of Rotarix, a vaccine used to prevent rotavirus disease. FDAÃ¢??s recommendation is a precaution taken while the agency learns more about the situation.
FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. PCV1 is not known to cause disease in humans. There is no evidence at this time that this finding poses a safety risk. Because available evidence supports the safety of Rotarix, no medical follow-up is needed for patients who have been vaccinated with Rotarix.
There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. For children who have received one dose of Rotarix, CDC advises that clinicians can complete the series with RotaTeq for the next two doses.
Additional information, including information for healthcare professionals and parents, is provided in the document below.
[05/14/2010 - Additional Information for Healthcare Providers - FDA]
[05/14/2010 - Information for Parents and Caregivers - FDA]
[03/22/2010 - Update on Rotarix Vaccine - FDA]