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Vaccination

Reactogenicity Following Receipt of mRNA-Based COVID-19 Vaccines

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

1 Credit CME

JAMA

Published Online: April 5, 2021

JAMA Insights

Article Information and Disclosures

Johanna Chapin-Bardales, PhD, MPH¹;

Julianne Gee, MPH¹;

Tanya Myers, PhD, MSc¹

Author Affiliations

¹CDC COVID-19 Response Team, Atlanta, Georgia

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In December 2020, 2 mRNA-based COVID-19 vaccines (Pfizer-BioNTech and Moderna) were granted Emergency Use Authorization by the US Food and Drug Administration as 2-dose series and recommended for use by the Advisory Committee on Immunization Practices.¹^- 3 In late February 2021, the US Food and Drug Administration granted Emergency Use Authorization for a third COVID-19 vaccine, a single-dose adenovirus vector-based vaccine from Janssen (Johnson & Johnson).

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Article Information

Corresponding Author: Johanna Chapin-Bardales, PhD, MPH, Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30329 (wif3@cdc.gov).

Published Online: April 5, 2021. doi:10.1001/jama.2021.5374

Conflict of Interest Disclosures: Drs Chapin-Bardales, Gee, and Myers reported receiving nonfinancial technical support to build and maintain the v-safe infrastructure for data capture and messaging to participants from Oracle during the conduct of the study.

Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the US Centers for Disease Control and Prevention (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 and the CDC v-safe team, members of the Oracle v-safe development team, and v-safe participants who contributed to these data.

Additional Information: See eg, 45 CFR part 46.102(l)(2); 21 CFR part 56; 42 USC §241(d); 5 USC §552a; 44 USC §3501 et seq.

References

Creech CB , Walker SC , Samuels RJ . SARS-CoV-2 vaccines. JAMA. 2021. doi:10.1001/jama.2021.3199 PubMed Google Scholar

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

Polack FP , Thomas SJ , Kitchin N , et al; C4591001 Clinical Trial Group. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603-2615. doi:10.1056/NEJMoa2034577 PubMed Google Scholar Crossref

Baden LR , El Sahly HM , Essink B , et al; COVE Study Group. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403-416. doi:10.1056/NEJMoa2035389 PubMed Google Scholar Crossref

V-safe protocol: version 2. Centers for Disease Control and Prevention. Published January 28, 2021. Accessed March 25, 2021. https://www.cdc.gov/vaccinesafety/pdf/V-safe-Protocol-508.pdf

Gee J , Marquez P , Su J , et al. First month of COVID-19 vaccine safety monitoring: United States, December 14, 2020-January 13, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(8):283-288. doi:10.15585/mmwr.mm7008e3 PubMed Google Scholar Crossref

Trends in number of COVID-19 vaccinations in the US. Centers for Disease Control and Prevention. Accessed March 20, 2021. https://covid.cdc.gov/covid-data-tracker/#vaccination-trends

Vaccines and immunizations: answering patients’ questions. Centers for Disease Control and Prevention. Updated November 2, 2020. Accessed March 25, 2021. https://www.cdc.gov/vaccines/covid-19/hcp/answering-questions.html

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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;
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