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    05 Covid Clark

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    Epoch Translator
    This document summarizes reports of anaphylaxis following the Pfizer-BioNTech COVID-19 vaccine in the UK and US. As of December 18, 2020, the CDC had identified 6 cases of anaphylaxis in the US meeting diagnostic criteria. The CDC is coordinating with partners to monitor safety, provide guidance on managing anaphylaxis at vaccination sites, and advise that those with previous anaphylaxis not receive additional doses. Surveillance efforts so far indicate timely reporting of potential adverse events.

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    05 Covid Clark

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    Epoch Translator
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    This document summarizes reports of anaphylaxis following the Pfizer-BioNTech COVID-19 vaccine in the UK and US. As of December 18, 2020, the CDC had identified 6 cases of anaphylaxis in the US meeting diagnostic criteria. The CDC is coordinating with partners to monitor safety, provide guidance on managing anaphylaxis at vaccination sites, and advise that those with previous anaphylaxis not receive additional doses. Surveillance efforts so far indicate timely reporting of potential adverse events.

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    This document summarizes reports of anaphylaxis following the Pfizer-BioNTech COVID-19 vaccine in the UK and US. As of December 18, 2020, the CDC had identified 6 cases of anaphylaxis in the US meeting diagnostic criteria. The CDC is coordinating with partners to monitor safety, provide guidance on managing anaphylaxis at vaccination sites, and advise that those with previous anaphylaxis not receive additional doses. Surveillance efforts so far indicate timely reporting of potential adverse events.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    17K views8 pages

    05 Covid Clark

    Uploaded by

    Epoch Translator
    This document summarizes reports of anaphylaxis following the Pfizer-BioNTech COVID-19 vaccine in the UK and US. As of December 18, 2020, the CDC had identified 6 cases of anaphylaxis in the US meeting diagnostic criteria. The CDC is coordinating with partners to monitor safety, provide guidance on managing anaphylaxis at vaccination sites, and advise that those with previous anaphylaxis not receive additional doses. Surveillance efforts so far indicate timely reporting of potential adverse events.

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    of 8

    ACIP COVID-19 Vaccines Work Group

    Anaphylaxis Following m-RNA COVID-19


    Vaccine Receipt

    Thomas Clark, MD, MPH


    December 19, 2020

    For more information: www.cdc.gov/COVID19


    Anaphylaxis in UK Following COVID-19 Vaccination
     December 8, 2020 – UK initiated vaccination with Pfizer-BioNTech
    COVID-19 vaccine
     December 9 – UK authorities confirmed 2 cases of anaphylaxis after
    vaccination
     Prescribing information for both Pfizer-BioNTech and Moderna COVID-19
    vaccines contains information on anaphylaxis
    – Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine is a
    contraindication to vaccination
    – Appropriate medical treatment used to manage immediate allergic reactions must
    be immediately available in the event an acute anaphylactic reaction occurs
    following administration of the vaccine

    2
    CDC Guidance on Anaphylaxis Following COVID-19
    Vaccination
     ACIP considered anaphylaxis risk during deliberations on Pfizer-BioNTech
    COVID-19 vaccine during December 11-12 meetings
     December 12 – CDC published clinical considerations for use of Pfizer-
    BioNTech COVID-19 vaccine
    – Included guidance on contraindications and precautions
    (https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-
    considerations.html#contraindications-precautions)
    Anaphylaxis in US Following COVID-19 Vaccination
     December 18*, 2020 – CDC has identified 6 case reports of anaphylaxis
    following Pfizer-BioNTech vaccine meeting Brighton Collaboration criteria for
    anaphylaxis
    – Cases were Brighton Collaboration levels 1 or 2
    – Additional case reports have been reviewed and determined not anaphylaxis
     Cases occurred within recommended observation window and were
    promptly treated
     One case had a history of anaphylaxis following rabies vaccination
     All suspect cases were notified through VAERS or CDC notification processes
     These case reports are undergoing/will undergo clinical case review by CISA
     December 19** – 272,001 doses of vaccine have been administered
    *December 18, 2020 at 2300 hrs EST
    **December 19, 2020 at 0945 hrs EST
    CDC Actions Following Reports

     Close coordination with FDA


     Discussions with CISA investigators, NIH, Medicine and Healthcare
    products Regulatory Agency (UK), Allergy/Immunology experts, and
    other partners
     Published Interim Considerations: Preparing for the Potential
    Management of Anaphylaxis at COVID-19 Vaccination
    Sites (https://www.cdc.gov/vaccines/covid-19/info-by-
    product/pfizer/anaphylaxis-management.html)
    V-safe Active Surveillance for COVID-19 Vaccines

    Dec 14 Dec 15 Dec 16 Dec 17 Dec 18*

    Registrants with recorded 1st dose 679 6,090 27,823 67,963 112,807

    Health Impact Events** 3 50 373 1,476 3,150

    Pregnancies at time of vaccination 5 29 103 286 514

    *Dec 18, 5:30 pm EST


    **unable to perform normal daily activities, unable to work, required care from doctor or health care professional
    CDC Assessment and Further Actions
     Post-authorization pharmacovigilance systems have detected and
    confirmed 6 anaphylaxis cases following vaccination
    – Notifications received have been timely
    – Notifications ruled out suggests systems are sensitive
     Reinforce measures to recognize, respond, and report anaphylaxis
     Persons with anaphylaxis following COVID-19 vaccination should not
    receive additional doses of COVID-19 vaccine
     Consultation with allergy/immunology experts to provide guidance on
    evaluation of persons following anaphylaxis to COVID-19 vaccine
    Thank you
    For more information, contact CDC
    1-800-CDC-INFO (232-4636)
    TTY: 1-888-232-6348 www.cdc.gov

    The findings and conclusions in this report are those of the authors and do not necessarily represent the
    official position of the Centers for Disease Control and Prevention.

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