Benefits trump risks of rotavirus vaccine-US panel

The benefits of rotavirus vaccines from GlaxoSmithKline Plc and Merck & Co Inc outweigh any risk from recently discovered contamination with a pig virus, members of a U.S. advisory panel said on Friday.

Pieces of DNA from porcine circovirus, or PCV, have been detected in Glaxo’s Rotarix and Merck’s Rotateq. Health officials say there is no evidence the virus is harmful to people. (See related Reuters Health story, May 7, 2010.)

Members of a Food and Drug Administration advisory panel said the vaccines carried impressive benefits from preventing rotavirus, which can cause fatal diarrhea, and agreed there was no evidence so far of harm to people from PCV.

Any risks “are at best theoretical,” said Dr. Melinda Wharton, a panelist and deputy director of the Center for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.

“Based on where we are with current knowledge, to me the known benefits clearly outweigh the risks,” she said.

The panel did not take any votes on formal recommendations to the agency.

In March the FDA and Glaxo advised doctors to stop using Rotarix after PCV-1 was found in the vaccine. Merck then tested its vaccine and the FDA announced Thursday the company found pieces of DNA from PCV-1 and a related virus, PCV-2.

The FDA said it wanted the advisory panel’s input before making new recommendations on either vaccine.

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GAITHERSBURG, Md. (Reuters)