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FDA: Emergency Use Authorization (EUA) Amendment

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  • FDA: Emergency Use Authorization (EUA) Amendment

    August 13, 2021

    Dr. Kathleen Dooling, MD, MPH
    Advisory Committee on Immunization Practices

    Evidence to Recommendation Framework:
    An Additional Dose of mRNA COVID-19 Vaccine Following a Primary Series in Immunocompromised People

    FDA: Emergency Use Authorization (EUA) Amendment
    • – Other fully vaccinated individuals do not need an additional dose right now
    • – Amendment applies to:

      – Pfizer-BioNTech COVID-19 vaccine (BNT162b2) (≥12 years old)– Moderna COVID-19 vaccine (mRNA-1273) (≥18 years old)
     August 12, 2021: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals*

     Due to insufficient data, the EUA amendment for an additional dose does not apply to Janssen COVID-19 vaccine or to individuals who received Janssen COVID-19 as a primary series. CDC and FDA are actively engaged to ensure that immunocompromised recipients of Janssen COVID-19 vaccine have optimal vaccine protection