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Vaccination

Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine

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1 Credit CME
JAMA
Published Online: January 21, 2021
JAMA Insights
Tom Shimabukuro, MD, MPH, MBA1;
Narayan Nair, MD2
Author Affiliations
  • 1Immunization Safety Office, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
  • 2Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
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COVID-19 Vaccine Safety–Anaphylaxis and Allergic Reactions
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On December 11, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine, administered as 2 doses separated by 21 days.1 Shortly after, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use.2 Following implementation of vaccination, reports of anaphylaxis after the first dose of the Pfizer-BioNTech COVID-19 vaccine emerged.3 Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours.4

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

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Vaccination Public Health Coronavirus (COVID-19)
Article Information

Corresponding Author: Tom Shimabukuro, MD, MPH, MBA, Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30329 (ayv6@cdc.gov).

Published Online: January 21, 2021. doi:10.1001/jama.2021.0600

Conflict of Interest Disclosures: None reported.

Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of CDC or FDA. Mention of a product or company name is for identification purposes only and does not constitute endorsement by CDC or FDA.

Additional Contributions: We thank investigators from the CDC COVID-19 Response Team; the FDA Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research; and the Clinical Immunization Safety Assessment Project.

References
1.
FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers): Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). Revised January 2021. Accessed January 17, 2021. https://www.fda.gov/media/144413/download
2.
Oliver  SE , Gargano  JW , Marin  M ,  et al.  The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 Vaccine—United States, December 2020.   MMWR Morb Mortal Wkly Rep. 2020;69(50):1922-1924. doi:10.15585/mmwr.mm6950e2 PubMedGoogle ScholarCrossref
3.
 Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine—United States, December 14–23, 2020.   MMWR Morb Mortal Wkly Rep. Published January 6, 2021. doi:10.15585/mmwr.mm7002e1Google Scholar
4.
McNeil  MM , DeStefano  F .  Vaccine-associated hypersensitivity.   J Allergy Clin Immunol. 2018;141(2):463-472. doi:10.1016/j.jaci.2017.12.971 PubMedGoogle ScholarCrossref
5.
Shimabukuro  TT , Nguyen  M , Martin  D , DeStefano  F .  Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).   Vaccine. 2015;33(36):4398-4405. PubMedGoogle ScholarCrossref
6.
Rüggeberg  JU , Gold  MS , Bayas  JM ,  et al.  Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data.   Vaccine. 2007;25(31):5675-5684. doi:10.1016/j.vaccine.2007.02.064 PubMedGoogle ScholarCrossref
7.
Rossen  LM , Branum  AM , Ahmad  FB ,  et al.  Excess deaths associated with COVID-19, by age and race and ethnicity—United States, January 26–October 3, 2020.   MMWR Morb Mortal Wkly Rep. 2020;69(42):1522-1527. doi:10.15585/mmwr.mm6942e2 PubMedGoogle ScholarCrossref
8.
CDC. Interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. Updated January 6, 2021. Accessed January 17, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
9.
CDC. Interim considerations: preparing for the potential management of anaphylaxis after COVID-19 vaccination. Updated December 31, 2020. Accessed January 18, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/anaphylaxis-management.html
10.
Vaccine Adverse Event Reporting System: report an adverse event to VAERS. Accessed January 18, 2021. https://vaers.hhs.gov/reportevent.html
AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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