The FDA Sent Invivyd An Advance Termination Notice For Pemgarda (Pemivibart) Emergency Use Authorization Following US Department Of Health And Human Services’ Announcement Of Advanced Notice Of Termination Of Covid-19 EUA Declaration On June 30, W...
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- U.S. Department of Health and Human Services (HHS) announced advanced Notice of Termination of the COVID-19 EUA declaration, effective June 29, 2027
- Consequently, Invivyd received from the U.S. Food and Drug Administration (FDA) Notice of Termination of the PEMGARDA EUA, to be effective on June 29, 2027, after a twelve-month transition period
- Consistent with EUA transition processes, Invivyd is in dialogue with FDA about appropriate next steps for PEMGARDA
- Invivyd intends to pursue every avenue to secure permanent, high quality medical protection from COVID infection for immune-compromised and other vulnerable Americans
- PEMGARDA has demonstrated strong protection from COVID in a contemporary randomized clinical trial, has been growing in clinical use for more than two years, and is a critical non-vaccine option for vulnerable Americans that combines high antiviral activity and attractive safety demonstrated in clinical trials and post-authorization monitoring