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# FDA Tightens Pemgarda Covid-19 EUA
- URL: https://www.fdaweb.com/fda-tightens-pemgarda-covid-19-eua/
- Published: 2024-08-27T12:00:00.000Z
- Updated: 2026-09-14T14:39:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157660

FDA approved 8/23 changes, including a limitation on authorized use, to the terms of the emergency use authorization for Invivyd’s Pemgarda (pemivibart) injection indicated for pre-exposure prophylaxis of Covid-19\. An agency [memo](https://www.fda.gov/media/181308/download?attachment&ref=fdaweb.com) lists these changes and the rationale for them:

- include Pemgarda pseudotyped virus-like particle neutralization activity data against recent and currently circulating SARS-CoV-2 variants;
- indicate the risk of Covid-19 due to SARS-CoV-2 variants with substantially reduced susceptibility to Pemgarda;
- add a limitation of authorized use for SARS-CoV-2 variants with substantially reduced susceptibility to Pemgarda;
- remove specific authentic virus neutralization data deemed no longer viable based on new information obtained from the sponsor;
- update immunobridging results; and
- add exploratory clinical efficacy results from the CANOPY trial.