The Food and Drug Administration (FDA) determined on May 14 that it is appropriate for U.S. clinicians and public health providers to resume the use of Rotarix (Glaxo SmithKline Biologicals) and to continue the use of RotaTeq (Merck & Co. Inc.) rotavirus vaccines.
In addition, a contraindication for use of the live-attenuated vaccines in infants with severe combined immunodeficiency (SCID) recently was added.
There is no evidence at this time that porcine circovirus-1 (PCV1) or PCV2 DNA recently detected in the rotavirus vaccines poses a health risk. PCV1 DNA likely was present throughout product development of Rotarix; PCV1 and PCV2 likely were present throughout the product development of RotaTeq. The established safety profile of these vaccines reflects exposure to PCV1 or PCV2.
There has been clear benefit from reduced hospitalizations for rotavirus gastroenteritis following the introduction of rotavirus vaccines in the United States, Mexico and other countries. Immunization with Rotarix...