WHITEHOUSE STATION, N.J., October 28, 2010 - At today's U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) meeting, Merck provided an update of its investigation and analysis of porcine circovirus 1 (PCV1) DNA fragments and
porcine circovirus 2 (PCV2) DNA fragments in ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent). In Merck's final test results, infectious PCV was not detected in ROTATEQ or in the starting materials used to make ROTATEQ. In addition, PCV1 DNA fragments were below the limit of detection, and PCV2 DNA fragments -- pieces of PCV2 and not the intact virus itself -- were at low levels in ROTATEQ.
In Merck's investigation, trypsin, the only porcine-derived raw material directly used in the manufacture of ROTATEQ, was confirmed as the source of PCV2 DNA fragments in ROTATEQ. Trypsin is an enzyme used in the manufacturing process for cell growth and rotavirus production.
There is information on PCV DNA in the Description section of the United States Prescribing Information for ROTATEQ. Specifically, the language in the section is as follows: "In the manufacturing process for ROTATEQ, a porcine-derived material is used. DNA from porcine circoviruses (PCV) 1 and 2 has been detected in ROTATEQ. PCV-1 and PCV-2 are not
known to cause disease in humans."
According to the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the world, there is no evidence that PCV1 or PCV2 poses a safety risk in humans, and neither is known to cause infection or illness in humans.
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