Vaccines Face Unknown Contamination Risks, But Need Well-Defined Testing
Executive Summary
The discovery of adventitious porcine virus in Merck's RotaTeq and GlaxoSmithKline's Rotarix is setting off a scramble among vaccine manufacturers and FDA to come up with validated procedures to detect and deal with such undesirable agents
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Vaccine Manufacturers Need Plans To Cut Adventitious Agents By October
FDA is sending two rounds of letters to different sets of companies asking for the plans as part of the fall-out from the issues seen in rotavirus vaccines.
GSK's Rotarix: A Theoretical Risk Isn't Enough To Keep It Off The Market
FDA's May 14 decision that GlaxoSmithKline's Rotarix and Merck's RotaTeq should be offered to the public, even after both vaccines were found to contain DNA from porcine circovirus, signals that the agency is valuing the benefits of the products over the theoretical risk