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After EUA, COVID Vaccine Sponsors Need Plans For Continuing Trials

 
• By Sue Sutter

EUA request should also include plan for a sponsor’s active follow-up for safety among individuals given the vaccine under EUA – including assessing deaths, hospitalizations and other clinically significant adverse events – to inform ongoing benefit-risk determinations to support the continued authorization, US FDA says in its finally-released guidance.

The US Food and Drug Administration wants COVID-19 vaccine developers to have plans for ensuring their clinical trials will continue after an emergency use authorization is granted and that product safety is actively followed in individuals vaccinated under an EUA.

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