Comment from Anonymous

I support careful FDA review of the licensure status of Comirnaty and Spikevax and request a full, transparent response to the December 8, 2025 citizen petition. I am concerned that the public still lacks confidence that the evidentiary basis for full licensure was sufficiently rigorous and fully transparent. I ask FDA to clearly explain the data, standards, and regulatory reasoning used to support licensure, including how those standards compared with ordinary expectations for biologics licensure. I also ask FDA to address ongoing safety concerns in a direct and accessible way. The agency has already required updated warnings regarding myocarditis and pericarditis for mRNA COVID-19 vaccines, which shows that continued safety scrutiny remains important. Please provide a detailed public response to the petition and make clear whether the current licenses remain justified based on the totality of evidence.