US FDA v. COVID Mutants: Multi-Factorial Assessments Will Determine When Product EUAs Need To Change

Acting Commissioner Janet Woodcock offers hints as to the content of upcoming guidance on how emerging virus variants may impact vaccine and therapeutic development. US may need multivalent vaccine and multiple boosters. 

COVID gears (shutterstock)
FDA is conducting wide-ranging scenario planning to deal with virus changes • Source: Shutterstock

The US Food and Drug Administration will be taking several factors into consideration as it decides whether to pull an emergency use authorization for COVID-19 therapeutics or require vaccines to be updated due to emerging variants of the SARS-CoV-2 virus.

Draft guidance on these topics should be available in several weeks, Acting Commissioner Janet Woodcock said on 4 February, and...

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