US Food and Drug Administration investigators painted a portrait 20 April of an Emergent BioSolutions, Inc. facility so overwhelmed by the challenge of manufacturing drug substances for two COVID-19 vaccines that it could not prevent their cross-contamination.
Emergent COVID-19 Vaccine Plant’s Quality Issues Draw Unusual Spotlight From US FDA Topsiders
Remediation must be quick and sure, say FDA’s Woodcock and Marks, despite challenges with facilities, equipment, processes and personnel training.
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The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.
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FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
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In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
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The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.