Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the Development and Licensure of Vaccines to Prevent COVID-19 (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance back in March 2023, when it announced that the current policy on Emergency Use Authorizations (EUAs) for COVID-19 vaccines would expire on November 7, 2023, unless superseded by another policy before that date. While the Guidance does not indicate that it replaces the previous EUA guidance, it is significant because FDA does clearly state that, “At this time, the goal of new vaccine development programs to prevent COVID-19 should be to pursue traditional approval[.]”
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