CFCWP Efficacy and Safety Health Article Summary Paper

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Early Antiretroviral Therapy and Mortality among HIV-Infected Infants Jane Doe, Pharm.D. Candidate Pre-APPE Performance Skills & Lab January 16, 2021 Title: Early Antiretroviral Therapy and Mortality among HIV-Infected Infants Authors: Citation: Type of Study: Background: Objective: Methodology: Statistical Analysis: Results: Conclusion: Critique: Strengths Weaknesses 2 References: 3 The n e w e ng l a n d j o u r na l of m e dic i n e Original Article Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico L.M. Dunkle, K.L. Kotloff, C.L. Gay, G. Áñez, J.M. Adelglass, A.Q. Barrat Hernández, W.L. Harper, D.M. Duncanson, M.A. McArthur, D.F. Florescu, R.S. McClelland, V. Garcia‑Fragoso, R.A. Riesenberg, D.B. Musante, D.L. Fried, B.E. Safirstein, M. McKenzie, R.J. Jeanfreau, J.K. Kingsley, J.A. Henderson, D.C. Lane, G.M. Ruíz‑Palacios, L. Corey, K.M. Neuzil, R.W. Coombs, A.L. Greninger, J. Hutter, J.A. Ake, K. Smith, W. Woo, I. Cho, G.M. Glenn, and F. Dubovsky, for the 2019nCoV-301 Study Group*​​ A BS T R AC T BACKGROUND NVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b–3 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America. The authors’ full names, academic degrees, and affiliations are listed in the Appendix. Dr. Dunkle can be contacted at ­ldunkle@​­novavax​.­com or at Novavax, 21 Firstfield Rd., Gaithersburg, MD 20878. METHODS *The members of the 2019nCoV-301 Study Group are listed in the Supplementary Appendix, available at NEJM.org. We conducted a phase 3, randomized, observer-blinded, placebo-controlled trial in the United States and Mexico during the first half of 2021 to evaluate the efficacy and safety of NVX-CoV2373 in adults (≥18 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants were randomly assigned in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart. The primary objective was to determine vaccine efficacy against reversetranscriptase–polymerase-chain-reaction–confirmed Covid-19 occurring at least 7 days after the second dose. Vaccine efficacy against moderate-to-severe disease and against different variants was also assessed. Drs. Dunkle, Kotloff, and Gay contributed equally to this article. This article was published on December 15, 2021, at NEJM.org. DOI: 10.1056/NEJMoa2116185 Copyright © 2021 Massachusetts Medical Society. RESULTS Of the 29,949 participants who underwent randomization between December 27, 2020, and February 18, 2021, a total of 29,582 (median age, 47 years; 12.6% ≥65 years of age) received at least one dose: 19,714 received vaccine and 9868 placebo. Over a period of 3 months, 77 cases of Covid-19 were noted — 14 among vaccine recipients and 63 among placebo recipients (vaccine efficacy, 90.4%; 95% confidence interval [CI], 82.9 to 94.6; P
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Running head: A HEALTH ARTICLE SUMMARY

A Health Article Summary
Student’s Name
Institution Affiliation
Date

1

A HEALTH ARTICLE SUMMARY

2

A Health Article Summary
Title
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
Authors
L.M. Dunkle, K.L. Kotloff, C.L. Gay, G. Áñez, J.M. Adelglass, A.Q. Barrat
Hernández, W.L. Harper, D.M. Duncanson, M.A. McArthur, D.F. Florescu, R.S. McClelland,
V. Garcia-Fragoso, R.A. Riesenberg, D.B. Musante, D.L. Fried, B.E. Safirstein, M.
McKenzie, R.J. Jeanfreau, J.K. Kingsley, J.A. Henderson, D.C. Lane, G.M. Ruíz-Palacios, L.
Corey, K.M. Neuzil, R.W. Coombs, A.L. Greninger, J. Hutter, J.A. Ake, K. Smith, W. Woo,
I. Cho, G.M. Glenn, and F. Dubovsky, for the 2019nCoV-301 Study Group.
Citation
L.M. Dunkle, K. K. et al. (2021). Efficacy and Safety of NVX-CoV2373. The New
England Journal of Medicine, 13.
Type of Study
The study was a randomized placebo-controlled trial conducted in the United States
and Mexico during a half-year period in 2021.
Background
The Coronavirus (Covid-19) disease caused by SARS-Cov-2 (Severe Acute
Respiratory Syndrome Coronavirus 2) has led to the innovation of various types of vaccines
that use the SARS-Cov-2 spike protein. The NVX-CoV2373 is one of the disea...


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