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EUA For COVID-19 Vaccine Would Mean Fewer Patient-Years Of Follow-Up But More Pharmacovigilance

 
• By Sue Sutter

US FDA plans to leverage large safety surveillance databases to make up for the fact that a vaccine authorized for emergency use likely would have only one-quarter to one-half as much safety data follow-up as a typical vaccine licensed under a BLA, says CBER director Peter Marks.

Building up trust concept: Black alphabetic letters forming the word trust being set up by group of construction machines, isolated on white background.
CBER Director Peter Marks sees his primary job in the coming weeks as helping to rebuild public trust in vaccines. • Source: Shutterstock

A COVID-19 vaccine that comes to the US market under an emergency use authorization is likely to have one-quarter to one-half as much safety data in length of follow-up relative to a typical vaccine approved under a biologics license application.

However, what the US Food and Drug Administration may lack in patient-years of safety follow-up preauthorization it intends to make up for through enhanced pharmacovigilance, including leveraging large surveillance systems that are capable of identifying vaccine

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