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Vaccination

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

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To identify the key insights or developments described in this article

1 Credit CME

JAMA

Published Online: February 12, 2021

JAMA Insights

Article Information and Disclosures

Tom T. Shimabukuro, MD, MPH, MBA¹;

Matthew Cole, MPH²;

John R. Su, MD, PhD, MPH¹

Author Affiliations

¹Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
²Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia

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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

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 PubMed Google Scholar Crossref

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.mm695152e1 PubMed Google Scholar Crossref

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.2021.0600 PubMed Google Scholar

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.mm7004e1 PubMed Google Scholar Crossref

McNeil MM , DeStefano F . Vaccine-associated hypersensitivity. J Allergy Clin Immunol. 2018;141(2):463-472. doi:10.1016/j.jaci.2017.12.971 PubMed Google Scholar Crossref

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 PubMed Google Scholar Crossref

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 PubMed Google Scholar Crossref

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 PubMed Google Scholar Crossref

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

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

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.