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An Inactivated Virus Candidate Vaccine to Prevent COVID-19

Educational Objective
To understand how an inactivate virus vaccine can be used to prevent COVID-19
1 Credit CME

The global struggle against coronavirus disease 2019 (COVID-19) is now in its eighth month since the pandemic virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), first emerged. The severe economic, personal, and psychological adverse effects of shutdowns and social distancing make these effective preventive measures challenging to sustain long-term. In 1999, just before the launch of a new millennium, the Centers for Disease Control and Prevention listed vaccines as the most important public health achievement of the 20th century.1 According to one estimate, more than 42 000 children’s lives are saved annually as a result of the US programs of routine childhood immunizations.2 Safe and effective COVID-19 vaccines could lead to a level of global immunity that stops the pandemic. This is the anti–COVID-19 intervention most public health leaders and many people long for the most.

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Article Information

Corresponding Author: Mark J. Mulligan, MD, NYU Grossman School of Medicine, Alexandria Center for Life Sciences (West Tower), 430 E 29th St, Room 304, New York, NY 10016 (mark.mulligan@nyulangone.org).

Published Online: August 13, 2020. doi:10.1001/jama.2020.15539

Conflict of Interest Disclosures: Dr Mulligan reported receiving grants from the National Institutes of Health/National Institute of Allergy and Infectious Diseases, Eli Lilly, Pfizer, and Sanofi and personal fees from Meissa Vaccines.

References
1.
Centers for Disease Control and Prevention (CDC).  Ten great public health achievements: United States, 1900-1999.   MMWR Morb Mortal Wkly Rep. 1999;48(12):241-243.PubMedGoogle Scholar
2.
Zhou  F , Shefer  A , Wenger  J ,  et al.  Economic evaluation of the routine childhood immunization program in the United States, 2009.   Pediatrics. 2014;133(4):577-585. doi:10.1542/peds.2013-0698PubMedGoogle ScholarCrossref
3.
Zhu  FC , Li  YH , Guan  XH ,  et al.  Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial.   Lancet. 2020;395(10240):1845-1854. doi:10.1016/S0140-6736(20)31208-3PubMedGoogle ScholarCrossref
4.
Zhu  FC , Guan  XH , Li  YH ,  et al.  Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial.   Lancet. Published online July 20, 2020. doi:10.1016/S0140-6736(20)31605-6PubMedGoogle Scholar
5.
Mulligan  MJ , Lyke  KE , Kitchin  N ,  et al.  Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults.   Nature. Published online August 12, 2020. doi:10.1038/s41586-020-2639-4Google Scholar
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Jackson  LA , Anderson  EJ , Rouphael  NG ,  et al; mRNA-1273 Study Group.  An mRNA vaccine against SARS-CoV-2: preliminary report.   N Engl J Med. Published online July 14, 2020. doi:10.1056/NEJMoa2022483PubMedGoogle Scholar
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Folegatti  PM , Ewer  KJ , Aley  PK ,  et al; Oxford COVID Vaccine Trial Group.  Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial.   Lancet. 2020;S0140-6736(20)31604-4. doi:10.1016/S0140-6736(20)31604-4PubMedGoogle Scholar
8.
Sahin  U , Muik  A , Derhovanessian  E ,  et al. Concurrent human antibody and TH1 type T-cell responses elicited by a COVID-19 RNA vaccine. medRxiv. Preprint posted July 20, 2020. doi:10.1101/2020.07.17.20140533
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Food and Drug Administration. Development and licensure of vaccines to prevent COVID-19: guidance for industry. Published June 2020. Accessed August 10, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19
10.
Xia  S , Duan  K , Zhang  Y ,  et al.  Effect of an inactivated vaccine against SARS-CoV-2 on safety and immunogenicity outcomes: interim analysis of 2 randomized clinical trials.   JAMA. Published August 13, 2020. doi:10.1001/jama.2020.15543Google Scholar
11.
Kim  HW , Canchola  JG , Brandt  CD ,  et al.  Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine.   Am J Epidemiol. 1969;89(4):422-434. doi:10.1093/oxfordjournals.aje.a120955PubMedGoogle ScholarCrossref
12.
Fulginiti  VA , Eller  JJ , Downie  AW , Kempe  CH .  Altered reactivity to measles virus: atypical measles in children previously immunized with inactivated measles virus vaccines.   JAMA. 1967;202(12):1075-1080. doi:10.1001/jama.1967.03130250057008PubMedGoogle ScholarCrossref
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Graham  BS .  Rapid COVID-19 vaccine development.   Science. 2020;368(6494):945-946. doi:10.1126/science.abb8923PubMedGoogle 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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