COVID-19 Vaccine EUA Process Compresses Advisory Committee Prep Too
US FDA wants briefing documents when EUA is submitted to accommodate timely advisory committee reviews; unlike traditional assessment process, the agency does not appear interested in engaging in back-and-forth discussions with sponsors about portions of the briefing document that should be made public or redacted.
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Novavax Readies COVID-19 Vaccine Request For EUA, But How Much Longer Will The Door Be Open?
Availability of emergency authorization route in US depends upon lack of 'adequate, approved and available alternatives,' but as more vaccines make their way through the BLA process sponsors may find the EUA door slowly closing.
Moderna Gets To Watch And Learn From Pfizer’s COVID-19 Vaccine Advisory Committee
US FDA will simultaneously review the vaccines, with Moderna’s advisory committee set a week after Pfizer’s. ACIP emergency meeting scheduled for 1 December with vote likely on distribution priority for health care personnel.
Novavax May Seek COVID-19 Vaccine Emergency Authorization In US Based On UK Data
With its US/Mexico Phase III trial delayed due to manufacturing questions, Novavax has aligned its UK study with FDA guidance. It hopes for interim data from that study during Q1 2021.