Public Health and Medical Professionals for Transparency Documents

As of November 2023, FDA has represented that the production of the biologic product file for Comirnaty (16 years of age and older) is complete. PHMPT is reviewing the production to determine: (1) whether the search FDA conducted appears adequate (in other words, did FDA produce everything expected from the product file concerning safety and efficacy of Comirnaty); and (2) whether there are any potentially improper withholdings or redactions.

If you believe there are improper redactions or withholdings, or if there are records missing, please fill out the form below.

Name: *

Email: *

Brief description of improper withholdings/redactions and/or potentially missing records (reference specific records or Bates numbers in the production where possible):

Brief justification for belief that withholdings/redactions are improper or why records are missing:

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