Increased transparency on serious adverse events from COVID-19 vaccines.
This Act aims to boost public confidence by requiring regular reporting to Congress of all serious adverse events linked to COVID-19 vaccines. Citizens will gain access to more detailed and timely information regarding vaccine safety, enabling them to make informed health decisions. These reports must be jointly prepared by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) every 60 days.
Key points
Reporting Mandate: The FDA and CDC must jointly report to Congress all serious adverse events reported in connection with COVID-19 vaccines.
Frequency: Reports must be submitted every 60 days, starting 60 days after the Act's enactment.
Data Scope: Reports cover events reported through the VAERS system or otherwise, starting from the date of the first emergency use authorization for a COVID-19 vaccine.
Expired
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