Are vaccines given an Emergency Use Authorization really safe?
“Emergency Use Authorization” cuts bureaucracy, not testing.
The difference is in the review process: The only difference between Emergency Use Authorization (EUA) and regular approval is who reviews the data from the clinical trials. The amount of testing is the same.
The FDA has a rapid authorization process for emergency situations. Emergency Use Authorization requires exactly the same 3-phase clinical trials as regular FDA approval. They save time by simplifying the review process and by letting the emergency treatment cut to the head of the line.
The regular process includes outsiders. The regular FDA review process gives the trial data to an external committee of scientists for review. The FDA looks at their feedback as part of their decision to approve or refuse authorization.
In an emergency, the FDA replaces the external committee with an INTERNAL panel of globally renowned experts. That cuts the time the review takes down to weeks instead of months.
Issue Tracking is the same. Once approved, all vaccines – regular and EUA – are rigorously tracked for safety through several reporting systems like Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), the Biologics Effectiveness and Safety (BEST) Initiative, and Medicare claims data.
Bottom Line: The trial process is the same. The tracking is the same. The only difference is whether the data was reviewed by just the FDA or whether an independent panel of scientists gave their input.
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