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Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US—December 14, 2020-January 18, 2021

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

In December 2020, the US Food and Drug Administration (FDA) issued Emergency Use Authorizations for 2 mRNA-based vaccines for prevention of coronavirus disease 2019 (COVID-19): Pfizer-BioNTech COVID-19 vaccine (EUA issued December 11; 2 doses, 3 weeks apart) and Moderna COVID-19 vaccine (EUA issued December 18; 2 doses, 1 month apart). Shortly after each authorization, the Advisory Committee on Immunization Practices issued interim recommendations for use.1,2

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Article Information

Corresponding Author: Tom Shimabukuro, MD, MPH, MBA, Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30329 (tshimabukuro@cdc.gov).

Published Online: February 12, 2021. doi:10.1001/jama.2021.1967

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 the CDC. Mention of a product or company name is for identification purposes only and does not constitute endorsement by the CDC.

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.
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
2.
Oliver  SE , Gargano  JW , Marin  M ,  et al.  The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine—United States, December 2020.   MMWR Morb Mortal Wkly Rep. 2021;69(5152):1653-1656. doi:10.15585/mmwr.mm695152e1PubMedGoogle ScholarCrossref
3.
Shimabukuro  T , Nair  N .  Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine.   JAMA. Published online January 21, 2021. doi:10.1001/jama.2021.0600PubMedGoogle Scholar
4.
CDC COVID-19 Response Team; Food and Drug Administration.  Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine—United States, December 21, 2020-January 10, 2021.   MMWR Morb Mortal Wkly Rep. 2021;70(4):125-129. doi:10.15585/mmwr.mm7004e1PubMedGoogle ScholarCrossref
5.
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
6.
Shimabukuro  TT , Nguyen  M , Martin  D , DeStefano  F .  Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).   Vaccine. 2015;33(36):4398-4405. doi:10.1016/j.vaccine.2015.07.035 PubMedGoogle ScholarCrossref
7.
Rüggeberg  JU , Gold  MS , Bayas  JM ,  et al; Brighton Collaboration Anaphylaxis Working Group.  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
8.
Rossen  LM , Branum  AM , Ahmad  FB , Sutton  P , Anderson  RN .  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
9.
CDC. COVID-19 vaccination: interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. Updated January 21, 2021. Accessed February 9, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
10.
CDC. COVID-19 vaccination: interim considerations: preparing for the potential management of anaphylaxis after COVID-19 vaccination. Updated December 31, 2020. Accessed February 9, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/anaphylaxis-management.html
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