Alliance for mRNA Medicines opposes citizen petition that challenges FDA’s approval of COVID-19 vaccines
The Alliance for mRNA Medicines (AMM) submitted comments to the U.S. Food and Drug Administration on March 19, 2026, responding to a December 8, 2025 “Citizen Petition” from Children’s Health Defense (docket FDA-2025-P-6831) that challenges FDA actions involving COVID-19 vaccines developed and manufactured by Moderna and Pfizer/BioNTech.
In its filing, AMM asked the agency to deny the petition and said the request does not present a legal basis to revisit the biologics license approvals for Moderna’s SPIKEVAX and Pfizer/BioNTech’s Comirnaty.
AMM’s comments focus on the regulatory path from Emergency Use Authorization (EUA) in December 2020 to full licensure through Biologics License Applications (BLAs) in 2021 and 2022.
AMM said both companies conducted randomized controlled trials under Investigational New Drug (IND) applications, with institutional review board oversight and informed consent. The filing also argues that distributing vaccines under EUA does not prevent later compliance with BLA standards, describing EUA and BLA as separate legal mechanisms. AMM further addressed claims related to manufacturing changes and testing methods, citing FDA’s use of comparability assessments for manufacturing updates and describing how clinical assays and SARS‑CoV‑2 tests used in pivotal studies were validated and fit for purpose under good clinical practice.
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Alliance for mRNA Medicines opposes citizen petition that challenges FDA’s approval of COVID-19 vaccines
The Alliance for mRNA Medicines (AMM) submitted comments to the U.S. Food and Drug Administration on March 19, 2026, responding to a December 8, 2025 “Citizen Petition” from Children’s Health Defense (docket FDA-2025-P-6831) that challenges FDA actions involving COVID-19 vaccines developed and manufactured by Moderna and Pfizer/BioNTech.
In its filing, AMM asked the agency to deny the petition and said the request does not present a legal basis to revisit the biologics license approvals for Moderna’s SPIKEVAX and Pfizer/BioNTech’s Comirnaty.
AMM’s comments focus on the regulatory path from Emergency Use Authorization (EUA) in December 2020 to full licensure through Biologics License Applications (BLAs) in 2021 and 2022.
AMM said both companies conducted randomized controlled trials under Investigational New Drug (IND) applications, with institutional review board oversight and informed consent. The filing also argues that distributing vaccines under EUA does not prevent later compliance with BLA standards, describing EUA and BLA as separate legal mechanisms. AMM further addressed claims related to manufacturing changes and testing methods, citing FDA’s use of comparability assessments for manufacturing updates and describing how clinical assays and SARS‑CoV‑2 tests used in pivotal studies were validated and fit for purpose under good clinical practice.
See comments here.