Covid-19 response

Does it matter that vaccines don't have full FDA approval?

  • 1.  Does it matter that vaccines don't have full FDA approval?

    Posted 15 days ago
    All the current vaccines got Emergency Use Authorization (EUA), not full FDA accreditation.  Does this matter in a legal setting?  What more will it take for these vaccines to get full FDA approval?

     

    An argument could be made that vaccines with EUA approval cannot be mandated, while vaccines with full FDA approval may be mandated.  No court, however, has interpreted this distinction.

    In certain emergencies, the FDA can issue an EUA to provide access to medical products that may potentially be used when there are no adequate, approved, and available options. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for full FDA approval.  EUAs are effective until the emergency declaration ends.



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    Timothy Atkinson
    NYSVMS
    Albany
    518-869-7867
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