Comment from Ajna Gupta

Comment for the U.S. Food and Drug Administration (Docket FDA-2025-P-6831) To the Honorable Commissioner of the U.S. Food and Drug Administration: I am submitting this comment in response to the Citizen Petition filed by Children’s Health Defense urging the FDA to revoke the existing biologics licenses for the Pfizer-BioNTech and Moderna COVID-19 vaccines. The FDA’s role in protecting public health depends fundamentally on the integrity of its regulatory processes and adherence to the legal standards established by federal statutes. As the agency responsible for ensuring that vaccines and other biologics meet rigorous requirements for safety, effectiveness, quality, and proper labeling, it is critical that the FDA demonstrate transparency in how it applies those standards. The concerns raised in this petition about whether all applicable licensing requirements were satisfied deserve thoughtful consideration. At the same time, the FDA must weigh any action with robust scientific evidence and a clear understanding of potential public health implications. Over the course of the COVID-19 pandemic, extensive studies and real-world data have consistently shown that licensed COVID-19 vaccines have significantly reduced severe disease and saved lives. Regulatory determinations should be grounded in the totality of scientific evidence, including established safety and efficacy outcomes from large-scale clinical and population studies. If there are gaps or uncertainties in documentation or regulatory procedures related to past licensure decisions, I encourage the FDA to address them through transparent review and, where appropriate, corrective action that upholds both scientific integrity and public confidence in vaccination policy. In evaluating this petition, I ask the FDA to: Clarify the legal and scientific basis for its original biologics licensing decisions and explain how all statutory and regulatory requirements were met. Provide a reasoned explanation of any deviations from standard licensure protocols and how those deviations affect public health considerations. Communicate openly with the public about the scientific evidence supporting the continued availability of licensed COVID-19 vaccines and how regulatory standards are being upheld. Maintaining trust in the vaccine approval process is essential — both for the credibility of the FDA and for the public’s confidence in immunization programs. Thank you for considering this comment and for your ongoing commitment to science-based regulation.