Novavax Push For COVID-19 Vaccine Manufacturing Capacity Delays Flu Vaccine Application
As CEO Erck touts that its COVID vaccine has the 'best data,' Novavax prepares to enter Phase III trials and inks deal with Serum Institute to boost production even as its 'almost a perfect flu vaccine' remains on hold.
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However, recruitment for adult trials remains robust, OWS’ Slaoui says.
Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated.
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.