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Postapproval Vaccine Safety Surveillance for COVID-19 Vaccines in the US

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

Since January 2020, more than 7.8 million cases of coronavirus disease 2019 (COVID-19) and 215 000 deaths have occurred in the US. In response to the pandemic, vaccine development has been moving at record speed through strong public or private partnerships, with nearly 200 vaccine candidates in development or in trials. In the US, 8 vaccine candidates have received federal support under Operation Warp Speed, and 4—from Moderna, Pfizer/BioNTech, Oxford/AstraZeneca, and Janssen—have entered phase 3 trials. Vaccines will be critical for the prevention and control of COVID-19 in the US and worldwide, yet these efforts cannot succeed without public confidence in a vaccination program. Demonstrating vaccine efficacy and safety during clinical trials and implementing a robust postlicensure vaccine safety monitoring system as the vaccine is deployed in larger, more diverse populations is central to public confidence and enabling timely and accurate policy decisions for population-level use.

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Article Information

Corresponding Author: Grace M. Lee, MD, MPH, Stanford University School of Medicine, 300 Pasteur Dr, H306-A, Stanford, CA 94305 (gmlee@stanfordchildrens.org).

Published Online: October 16, 2020. doi:10.1001/jama.2020.19692

Conflict of Interest Disclosures: Drs Lee, Bell, and Romero reported that they are members of the Advisory Committee on Immunization Practices. No other disclosures were reported.

References
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Lurie  N , Sharfstein  JM , Goodman  JL .  The development of COVID-19 vaccines: safeguards needed.   JAMA. 2020;324(5):439-440.PubMedGoogle ScholarCrossref
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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
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Centers for Disease Control and Prevention (CDC).  Intussusception among recipients of rotavirus vaccine—United States, 1998-1999.   MMWR Morb Mortal Wkly Rep. 1999;48(27):577-581.PubMedGoogle Scholar
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Shah  A , Marks  PW , Hahn  SM .  Unwavering regulatory safeguards for COVID-19 vaccines.   JAMA. 2020;324(10):931-932. doi:10.1001/jama.2020.15725PubMedGoogle ScholarCrossref
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Yih  WK , Kulldorff  M , Fireman  BH ,  et al.  Active surveillance for adverse events: the experience of the Vaccine Safety Datalink project.   Pediatrics. 2011;127(suppl 1):S54-S64. doi:10.1542/peds.2010-1722IPubMedGoogle ScholarCrossref
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Bauchner  H , Malani  PN , Sharfstein  J .  Reassuring the public and clinical community about the scientific review and approval of a COVID-19 vaccine.   JAMA. 2020;324(13):1296-1297.PubMedGoogle ScholarCrossref
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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