FDA Releases Industry Guidance on Development and Licensure of COVID-19 Vaccines

Patterson Belknap Webb & Tyler LLP

Patterson Belknap Webb & Tyler LLP

The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020.  This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. 

The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline.  Contact and communication with the agency is stressed throughout the guidance.  Given the accelerated timeline for vaccine development, the FDA advises that a plan for post-licensure safety evaluation be created.  The guidance advises submitting a Pharmacovigilance Plan (“PVP”) with the Biologics License Application (“BLA”) submission.

Well-designed studies, with agency input, will be of upmost importance.  Special attention should be paid to monitoring for vaccine-associated enhanced respiratory disease (“ERD”).

The studies should include a diversity of demographics, particularly at later trial phases.  The guidance advises that endpoints should include prevention of severe COVID-19 in addition to prevention of COVID-19.  As such, studies should be powered for both endpoints as well as for different demographic cohorts.

The FDA advises that it may be willing to consider surrogate endpoints, such as immune response.  The FDA also signaled willingness to allow the use of a controlled human infection model to ascertain efficacy if use of a clinical disease endpoint is not possible.  Finally, the FDA noted that it may be willing to issue Emergency Use Authorization (“EUA”) for efficacious and safe vaccines.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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