The U.S. Food and Drug Administration (FDA) has learned that DNA from porcine circovirus type 1 (PCV1), a virus not known to cause disease in humans, is present in the Rotarix vaccine. Rotavirus vaccines are given by mouth to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration.
Each year, rotavirus disease causes more than 500,000 deaths in infants globally, and more than 50,000 hospitalizations and several dozen deaths in the United States. There are two licensed rotavirus vaccines in the United States: RotaTeq (Merck) and Rotarix (GlaxoSmithKline).
This finding was reported to the FDA by GlaxoSmithKline on March 15, based on work originally performed by an academic research team using a novel technique to look for viruses. GlaxoSmithKline then conducted additional studies and confirmed that PCV1 DNA is present in the finished Rotarix vaccine, as well as in the cell bank and seed from which the vaccine is derived. This finding suggests that the PCV1 DNA has likely been present since the early stages of the vaccine's development.
While the FDA is learning more about the situation, the agency is recommending that clinicians temporarily suspend the use of Rotarix. This recommendation applies to all lots of the Rotarix vaccine. RotaTeq vaccine is available for rotavirus immunization during this period. For children who have received one dose of Rotarix, the CDC advises that clinicians complete the series with RotaTeq for the next two doses.
Since RotaTeq was licensed in 2006 and Rotarix in 2008, most children vaccinated in the United States received RotaTeq. The RotaTeq vaccine is made using a different process from the Rotarix vaccine. Preliminary studies by the FDA on the RotaTeq vaccine have not shown the presence of PCV1 DNA. The FDA is working with Merck to confirm these results.
Within the next four to six weeks, the FDA will convene an advisory committee to review the available data and make recommendations on the licensed rotavirus vaccines. The FDA will also seek input on the use of new techniques for identifying viruses in vaccines. The agency anticipates that following the advisory committee meeting, based on expert input and additional review, it will make further recommendations on the use of the two licensed rotavirus vaccines in the United States.
Clinicians are requested to report any suspected adverse events following Rotarix vaccination to the Vaccine Adverse Event Reporting System (VAERS) via phone at 800-822-7967 or online at http://vaers.hhs.gov.