Drug Fix: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion Rises
Update: 2025-08-29
Description
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of US Food and Drug Administration’s COVID-19 vaccine indication changes and recission of the associated emergency use authorizations, as well as the postmarketing studies that now are required (:40), and their potential impact on access and reimbursement (12:20 ).
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COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad: https://insights.citeline.com/pink-sheet/vaccines/covid-19-vaccines-pfizer-arguments-to-keep-eua-failed-to-persuade-us-fdas-prasad-V3X2OEBZE5HRHKO7KMMCFXBM2Q/
US FDA Updates COVID-19 Vaccine Formulations, Revokes EUAs, ACIP Use Decision Next: https://insights.citeline.com/pink-sheet/vaccines/us-fda-updates-covid-19-vaccine-formulations-revokes-euas-acip-use-decision-next-VBXJDSOA6BCOXNCA2TAH27EBJY/
A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions: https://insights.citeline.com/pink-sheet/vaccines/a-us-fda-move-to-revoke-pfizers-pediatric-covid-19-vaccine-eua-could-raise-supply-questions-ZX26DBENHFCOHPBGMPFPQB6REQ/
Changes In Pediatric COVID-19 Vaccine Recommendations Causing Coverage Confusion: https://insights.citeline.com/pink-sheet/vaccines/changes-in-pediatric-covid-19-vaccine-recommendations-causing-coverage-confusion-WDEYUVJXGBCGBEVBQ2I6INH554/
More On These Topics From The Pink Sheet
COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad: https://insights.citeline.com/pink-sheet/vaccines/covid-19-vaccines-pfizer-arguments-to-keep-eua-failed-to-persuade-us-fdas-prasad-V3X2OEBZE5HRHKO7KMMCFXBM2Q/
US FDA Updates COVID-19 Vaccine Formulations, Revokes EUAs, ACIP Use Decision Next: https://insights.citeline.com/pink-sheet/vaccines/us-fda-updates-covid-19-vaccine-formulations-revokes-euas-acip-use-decision-next-VBXJDSOA6BCOXNCA2TAH27EBJY/
A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions: https://insights.citeline.com/pink-sheet/vaccines/a-us-fda-move-to-revoke-pfizers-pediatric-covid-19-vaccine-eua-could-raise-supply-questions-ZX26DBENHFCOHPBGMPFPQB6REQ/
Changes In Pediatric COVID-19 Vaccine Recommendations Causing Coverage Confusion: https://insights.citeline.com/pink-sheet/vaccines/changes-in-pediatric-covid-19-vaccine-recommendations-causing-coverage-confusion-WDEYUVJXGBCGBEVBQ2I6INH554/
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