Has testing for circoviruses such as PCV1 been required as part of vaccine development?
Circoviruses have not been associated with illnesses in humans, and FDA has not required the routine testing of vaccines for these viruses. Current FDA guidance, released in March 2010, recommends that manufacturers consider testing for these agents. FDA introduced this recommendation as an additional precaution for vaccines manufactured with animal-based components. The agency is reviewing the current situation and may update its approach based on additional findings.
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