Understanding and Communicating about COVID-19 Vaccine Efficacy, Effectiveness, and Equity (2021) / Chapter Skim
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Understanding and Communicating about COVID-19 Vaccine Efficacy, Effectiveness, and Equity
Understanding and Communicating about COVID-19 Vaccine Efficacy, Effectiveness, and Equity
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* Senior Scholar, Johns Hopkins Center for Health Security This rapid expert consultation was produced through the Societal Experts Action Network (SEAN)
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State, tribal, local, and territorial officials can play a key role in conveying that information to community members or intermediaries in a timely, clear, authoritative way and in conveying community concerns to policy makers. This rapid expert consultation summarizes social, behavioral, and decision science research relevant to communicating how well COVID-19 vaccines work and how equitably they are being distributed.
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Vaccine efficacy is measured in clinical trials, typically randomized controlled trials, whereas vaccine effectiveness is measured in real-world deployment, using observational studies. Efficacy and effectiveness refer to individual outcomes.
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This rapid expert consultation offers strategies from social, behavioral, and decision science research regarding such communication.4 It first explains how well the COVID-19 vaccines work -- the evidence that needs to be communicated, potential barriers to understanding, and ways to overcome them -- focusing on the vital role of state, tribal, local, and territorial (STLT) health officials and their community partners.
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SOURCE: NASEM, 2021. UNDERSTANDING COVID-19 VACCINE EFFICACY Vaccine efficacy, as quantified in randomized clinical trials, is estimated as the average response of individuals who were vaccinated relative to those who were not.
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. For example, if the clinical endpoint is observed moderate-to-severe symptoms, a vaccine is 95 percent efficacious if a person receiving it has a 95 percent lower probability of experiencing those symptoms than a person who does not receive it (Olliaro, 2021)
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. Although the data are based on extremely small numbers, in their trials, the Pfizer and Johnson & Johnson vaccines were both 100 percent efficacious in preventing hospitalizations, while the Moderna vaccine was 89 percent efficacious.12 All three vaccines were 100 percent efficacious in 7 According to Dean and Madewell (2021)
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The Moderna vaccine had slightly lower efficacy for preventing symptomatic COVID-19 in individuals older than 65, with no difference related to race or ethnicity. Statistical power for detecting differences in these subgroups is necessarily smaller than in the overall trial.
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The report also recommends testing all messages to ensure that they are understood as intended, as well as monitoring changes in community trust and needs as the pandemic, the vaccine program, and the social environment evolve.15 The previous rapid expert consultation on Strategies for Building Confidence in COVID-19 Vaccines also provides strategies for public engagement that can also inform about how well the vaccine works (NASEM, 2021)
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. Earning community trust and building relationships "encompasses organizing for policy change, providing accessible COVID-19 testing and treatment, listening to the needs of communities, addressing the structural factors that create greater exposure to and poorer treatment for COVID-19, and ensuring the equitable allocation of vaccines" (NASEM, 2021, p.
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Clinical trials for the three currently authorized vaccines defined their clinical endpoints for efficacy differently. Unless the vaccines are described in the same terms, the public may be legitimately confused.
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. For example public health and other officials may do well to acknowledge that current efficacy results from clinical trials of the 3 vaccines currently available under emergency authorization show that some cases of mild disease are to be expected, even among those fully vaccinated.
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Transparent decision making, accountability, and effective messages together can garner public trust. CONCLUSION Many health experts interpret current scientific evidence as indicating that the best vaccine is the one a person can get.
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It requires a disciplined approach, characterizing vaccines in common terms; clearly comparing their risks and benefits; creating and disseminating records of vaccine distribution; eliciting community feedback; and developing effective messages, with the formative testing needed to ensure that they are understood as intended. Applying these research-based principles can help COVID-19 vaccine and distribution programs achieve their fullest contribution to public health and well-being.
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TABLE 1 Summary of Clinical Trial Results as of March 26, 2021 Pfizer BioNTech Vaccine Moderna Vaccine Johnson & Johnson (Janssen) Vaccine Clinical Endpoints for Defining Vaccine Efficacy Preventing Deatha 100% 100% 100% Preventing Hospitalizationsb 100% 89% 100% Preventing Symptomatic COVID-19c Preventing Preventing symptomatic Preventing moderate to symptomatic COVID- COVID-19: 94.1% severe COVID-19: 66.3% 19: 95% (beginning 7 20 For the Johnson & Johnson vaccine, five people in the placebo group were hospitalized and none in the vaccinated group within 28 days; for the Pfizer vaccine, two people in the placebo group were hospitalized and none in the vaccinated group; and for the Moderna vaccine, nine people in the placebo group were hospitalized and one in the vaccinated group (FDA, 2020a; 2020b; 2021a)
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. SOURCE: FDA, 2020a; 2020b; 2021a; 2021b.22 TABLE 2 Characteristics of Authorized COVID-19 Vaccines in the United States as of March 26, 2021 Pfizer BioNTech Vaccine Moderna Vaccine Johnson & Johnson (Janssen)
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The term "side effects" can confuse them with the adverse reactions central to decisions regarding safety and efficacy. d The interval between the Pfizer and Moderna vaccines can be up to 42 days between doses when a delay is unavoidable.
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Vaccine VRBPAC Briefing Document. Available: https://www.fda.gov/media/146217/download.
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. Communicating in a crisis: Risk communication guidelines for public officials.
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. Striving toward Equity: Utah's COVID-19 vaccine Distribution Roadmap.
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We thank Jeanne Ayers, Association of State and Territorial Health Officials; Matt Baum, Harvard University; Noel Brewer, University of North Carolina; Ron Carlee, Old Dominion University; Natalie Dean, University of Florida; Sandra Fryhofer, American Medical Association; Mirta Galesic, Santa Fe Institute; Branden Johnson, Decision Research; Linda Langston, National Association of Counties; Walt Orenstein, Emory University; Art Reingold, UC Berkeley; David Relman, Stanford University; and William Schaffner, Vanderbilt University. We also thank the following individuals for their review of this rapid expert consultation: LaQuandra S
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, Georgetown University DOMINIQUE BROSSARD, University of Wisconsin, Madison JANET CURRIE, Princeton, University MICHAEL HOUT, New York University ARATI PRABHAKAR, Actuate ADRIAN E RAFTERY, University of Washington JENNIFER RICHESON, Yale University Staff: MONICA N
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DUCHIN, University of Washington ELLEN EMBREY, Stratitia, Inc BARUCH FISCHHOFF, Carnegie Mellon University DIANE GRIFFIN, Johns Hopkins Bloomberg School of Public Health ROBERT GROVES, Georgetown University MARGARET HAMBURG, Foreign Associate, National Academy of Medicine DAN HANFLING, In-Q-Tel JOHN HICK, Hennepin County Medical Center KENT E KESTER, Sanofi Pasteur PATRICIA KING, Georgetown University Law Center JONNA MAZET, University of California, Davis School of Veterinary Medicine PHYLLIS MEADOWS, The Kresge Foundation TARA O'TOOLE, In-Q-Tel ALEXANDRA PHELAN, Georgetown University DAVID RELMAN, Stanford University MARK SMOLINSKI, Ending Pandemics DAVID WALT, Harvard Medical School Project Staff LISA BROWN, Senior Program Officer AUTUMN DOWNEY, Senior Program Officer CAROLYN SHORE, Senior Program Officer SCOTT WOLLEK, Senior Program Officer AURELIA ATTAL-JUNCQUA, Associate Program Officer EMMA FINE, Associate Program Officer BENJAMIN KAHN, Associate Program Officer MICHAEL BERRIOS, Research Associate BRIDGET BOREL, Administrative Assistant JULIE PAVLIN, Director, Board on Global Health ANDREW M
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