Adverse Reactions in the US to mRNA-Based Coronavirus Vaccines | Vaccination | JN Learning | AMA Ed Hub [Skip to Content]
[Skip to Content Landing]

Reactogenicity Following Receipt of mRNA-Based COVID-19 Vaccines

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

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.13 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).

Sign in to take quiz and track your certificates

Buy This Activity

JN Learning™ is the home for CME and MOC from the JAMA Network. Search by specialty or US state and earn AMA PRA Category 1 CME Credit™ from articles, audio, Clinical Challenges and more. Learn more about CME/MOC

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
1.
Creech  CB , Walker  SC , Samuels  RJ .  SARS-CoV-2 vaccines.   JAMA. 2021. doi:10.1001/jama.2021.3199PubMedGoogle Scholar
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.mm6950e2PubMedGoogle ScholarCrossref
3.
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
4.
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/NEJMoa2034577PubMedGoogle ScholarCrossref
5.
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/NEJMoa2035389PubMedGoogle ScholarCrossref
6.
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
7.
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.mm7008e3PubMedGoogle ScholarCrossref
8.
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
9.
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
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_Multimedia_LoginSubscribe_Purchase
Close
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_Multimedia_LoginSubscribe_Purchase
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close

Name Your Search

Save Search
Close
With a personal account, you can:
  • Track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
jn-learning_Modal_SaveSearch_NoAccess_Purchase
Close

Lookup An Activity

or

Close

My Saved Searches

You currently have no searches saved.

Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close