Revised Recommendations for Rotavirus

FDA Recommends Clinicians Resume Use of Rotarix and Continue Use of RotaTeq

In May 2010 the U.S. Food and Drug Administration revised its recommendations for rotavirus vaccines for the prevention of the disease in infants 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. 

 

These recommendations come after components of extraneous virus were detected in Rotarix vaccine in April 2010. The presence of components of porcine circovirus type 1 (PCV1) in Rotarix was discovered when an independent US academic research team applied a new technology for detecting viral genetic material.  The researchers detected DNA fragments of PCV1 in two lots of the Rotarix vaccine. At the time, FDA recommended that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learned more. PCV1 and PCV2 were subsequently found in RotaTeq vaccine upon investigation. The decision to resume use of Rotarix and continue use of RotaTeq in May 2010 is the most current recommendation from FDA.

 

The agency reached its decision 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, including members of the FDA's Vaccines and Related Biological Products Advisory Committee that convened on May 7, 2010, to discuss these vaccines.

The FDA also considered the following in its decision:

 

  • Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of vaccine recipients.
  • The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans.
  • The benefits of the vaccines are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. These benefits outweigh the risk, which is theoretical.

 

 

 

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Last Updated: 5/21/2010





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