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Article ; Online: Ethical considerations for epidemic vaccine trials.

Monrad, Joshua Teperowski

2020 Volume 46, Issue 7, Page(s) 465–469

Abstract: Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers ... ...

Abstract	Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines.
MeSH term(s)	Betacoronavirus ; Bioethical Issues ; COVID-19 ; Clinical Trials as Topic/ethics ; Clinical Trials as Topic/organization & administration ; Coronavirus Infections/epidemiology ; Coronavirus Infections/prevention & control ; Health Care Rationing/ethics ; Humans ; Pandemics/prevention & control ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/prevention & control ; SARS-CoV-2 ; Viral Vaccines/administration & dosage ; Viral Vaccines/economics ; Viral Vaccines/immunology
Chemical Substances	Viral Vaccines
Keywords	covid19
Language	English
Publishing date	2020-05-15
Publishing country	England
Document type	Journal Article
ZDB-ID	194927-5
ISSN	1473-4257 ; 0306-6800
ISSN (online)	1473-4257
ISSN	0306-6800
DOI	10.1136/medethics-2020-106235
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Supply, then demand? Health expenditure, political leanings, cost obstacles to care, and vaccine hesitancy predict state-level COVID-19 vaccination rates.

Teperowski Monrad, Joshua / Quaade, Sebastian / Powell-Jackson, Timothy

Vaccine

2022 Volume 40, Issue 45, Page(s) 6528–6548

Abstract: Objectives: To examine predictors of state-level COVID-19 vaccination rates during the first nine months of 2021.: Methods: Using publicly available data, we employ a robust, iteratively re-weighted least squares multivariable regression with state ... ...

Abstract	Objectives: To examine predictors of state-level COVID-19 vaccination rates during the first nine months of 2021. Methods: Using publicly available data, we employ a robust, iteratively re-weighted least squares multivariable regression with state characteristics as the independent variables and vaccinations per capita as the outcome. We run this regression for each day between February 1 and September 21, the last day before vaccine booster rollout. Results: We identify associations between vaccination rates and several state characteristics, including health expenditure, vaccine hesitancy, cost obstacles to care, Democratic voting, and elderly population share. We show that the determinants of vaccination rates have evolved: while supply-side factors were most clearly associated with early vaccination uptake, demand-side factors have become increasingly salient over time. We find that our results are generally robust to a range of alternative specifications. Conclusions: Both supply and demand-side factors relate to vaccination coverage and the determinants of success have changed over time. Policy implications: Investing in health capacity may improve early vaccine distribution and administration, while overcoming vaccine hesitancy and cost obstacles to care may be crucial for later immunisation campaign stages.
MeSH term(s)	Aged ; Humans ; COVID-19 Vaccines ; Health Expenditures ; Vaccination Hesitancy ; COVID-19/prevention & control ; Vaccination/methods ; Vaccines
Chemical Substances	COVID-19 Vaccines ; Vaccines
Language	English
Publishing date	2022-09-08
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2022.08.050
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Article ; Online: Ethical considerations for epidemic vaccine trials

Monrad, Joshua Teperowski

Journal of Medical Ethics

2020 Volume 46, Issue 7, Page(s) 465–469

Abstract	Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines.
Keywords	Health Policy ; Arts and Humanities (miscellaneous) ; Issues, ethics and legal aspects ; Health(social science) ; covid19
Language	English
Publisher	BMJ
Publishing country	uk
Document type	Article ; Online
ZDB-ID	194927-5
ISSN	1473-4257 ; 0306-6800
ISSN (online)	1473-4257
ISSN	0306-6800
DOI	10.1136/medethics-2020-106235
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Ethical considerations for epidemic vaccine trials

Monrad, Joshua Teperowski

J Med Ethics

Abstract	Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #266625
Database	COVID19

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Book ; Online: Ethical considerations for epidemic vaccine trials

Monrad, Joshua Teperowski

2020

Abstract	Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines.
Keywords	Current controversy ; covid19
Language	English
Publishing date	2020-07-01 00:00:00.0
Publisher	BMJ Publishing Group Ltd
Publishing country	us
Document type	Book ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Supply, then demand? Health expenditure, political leanings, cost obstacles to care, and vaccine hesitancy predict state-level COVID-19 vaccination rates

Teperowski Monrad, Joshua / Quaade, Sebastian / Powell-Jackson, Timothy

Vaccine. 2022 Aug. 22,

2022

Abstract: To examine predictors of state-level COVID-19 vaccination rates during the first nine months of 2021. Using publicly available data, we employ a robust, iteratively re- weighted least squares multivariable regression with state characteristics as the ... ...

Abstract	To examine predictors of state-level COVID-19 vaccination rates during the first nine months of 2021. Using publicly available data, we employ a robust, iteratively re- weighted least squares multivariable regression with state characteristics as the independent variables and vaccinations per capita as the outcome. We run this regression for each day between February 1 and September 21, the last day before vaccine booster rollout. We identify associations between vaccination rates and several state characteristics, including health expenditure, vaccine hesitancy, cost obstacles to care, Democratic voting, and elderly population share. We show that the determi- nants of vaccination rates have evolved: while supply-side factors were most clearly associated with early vaccination uptake, demand-side factors have become increas- ingly salient over time. We find that our results are generally robust to a range of alternative specifications. Both supply and demand-side factors relate to vaccination cov- erage and the determinants of success have changed over time. Policy Implications: Investing in health capacity may improve early vaccine distribution and administration, while overcoming vaccine hesitancy and cost ob- stacles to care may be crucial for later immunisation campaign stages.
Keywords	COVID-19 infection ; elderly ; health care costs ; issues and policy ; politics ; vaccination ; vaccines
Language	English
Dates of publication	2022-0822
Publishing place	Elsevier Ltd
Document type	Article
Note	Pre-press version
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2022.08.050
Database	NAL-Catalogue (AGRICOLA)

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Zs.MO 458: Show issues

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Article ; Online: Rapid Proliferation of Pandemic Research: Implications for Dual-Use Risks.

Musunuri, Sriharshita / Sandbrink, Jonas B / Monrad, Joshua Teperowski / Palmer, Megan J / Koblentz, Gregory D

mBio

2021 Volume 12, Issue 5, Page(s) e0186421

Abstract: The COVID-19 pandemic has demonstrated the world's vulnerability to biological catastrophe and elicited unprecedented scientific efforts. Some of this work and its derivatives, however, present dual-use risks (i.e., potential harm from misapplication of ... ...

Abstract	The COVID-19 pandemic has demonstrated the world's vulnerability to biological catastrophe and elicited unprecedented scientific efforts. Some of this work and its derivatives, however, present dual-use risks (i.e., potential harm from misapplication of beneficial research) that have largely gone unaddressed. For instance, gain-of-function studies and reverse genetics protocols may facilitate the engineering of concerning SARS-CoV-2 variants and other pathogens. The risk of accidental or deliberate release of dangerous pathogens may be increased by large-scale collection and characterization of zoonotic viruses undertaken in an effort to understand what enables animal-to-human transmission. These concerns are exacerbated by the rise of preprint publishing that circumvents a late-stage opportunity for dual-use oversight. To prevent the next global health emergency, we must avoid inadvertently increasing the threat of future biological events. This requires a nuanced and proactive approach to dual-use evaluation throughout the research life cycle, including the conception, funding, conduct, and dissemination of research.
MeSH term(s)	COVID-19/epidemiology ; Containment of Biohazards ; Global Health/statistics & numerical data ; Humans ; Pandemics
Language	English
Publishing date	2021-10-19
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2557172-2
ISSN	2150-7511 ; 2161-2129
ISSN (online)	2150-7511
ISSN	2161-2129
DOI	10.1128/mBio.01864-21
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Seasonal variation in SARS-CoV-2 transmission in temperate climates: A Bayesian modelling study in 143 European regions.

Gavenčiak, Tomáš / Monrad, Joshua Teperowski / Leech, Gavin / Sharma, Mrinank / Mindermann, Sören / Bhatt, Samir / Brauner, Jan / Kulveit, Jan

PLoS computational biology

2022 Volume 18, Issue 8, Page(s) e1010435

Abstract: Although seasonal variation has a known influence on the transmission of several respiratory viral infections, its role in SARS-CoV-2 transmission remains unclear. While there is a sizable and growing literature on environmental drivers of COVID-19 ... ...

Abstract	Although seasonal variation has a known influence on the transmission of several respiratory viral infections, its role in SARS-CoV-2 transmission remains unclear. While there is a sizable and growing literature on environmental drivers of COVID-19 transmission, recent reviews have highlighted conflicting and inconclusive findings. This indeterminacy partly owes to the fact that seasonal variation relates to viral transmission by a complicated web of causal pathways, including many interacting biological and behavioural factors. Since analyses of specific factors cannot determine the aggregate strength of seasonal forcing, we sidestep the challenge of disentangling various possible causal paths in favor of a holistic approach. We model seasonality as a sinusoidal variation in transmission and infer a single Bayesian estimate of the overall seasonal effect. By extending two state-of-the-art models of non-pharmaceutical intervention (NPI) effects and their datasets covering 143 regions in temperate Europe, we are able to adjust our estimates for the role of both NPIs and mobility patterns in reducing transmission. We find strong seasonal patterns, consistent with a reduction in the time-varying reproduction number R(t) (the expected number of new infections generated by an infectious individual at time t) of 42.1% (95% CI: 24.7%-53.4%) from the peak of winter to the peak of summer. These results imply that the seasonality of SARS-CoV-2 transmission is comparable in magnitude to the most effective individual NPIs but less than the combined effect of multiple interventions.
MeSH term(s)	Bayes Theorem ; COVID-19/epidemiology ; Climate ; Humans ; SARS-CoV-2 ; Seasons
Language	English
Publishing date	2022-08-26
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2193340-6
ISSN	1553-7358 ; 1553-734X
ISSN (online)	1553-7358
ISSN	1553-734X
DOI	10.1371/journal.pcbi.1010435
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Mask wearing in community settings reduces SARS-CoV-2 transmission.

Leech, Gavin / Rogers-Smith, Charlie / Monrad, Joshua Teperowski / Sandbrink, Jonas B / Snodin, Benedict / Zinkov, Robert / Rader, Benjamin / Brownstein, John S / Gal, Yarin / Bhatt, Samir / Sharma, Mrinank / Mindermann, Sören / Brauner, Jan M / Aitchison, Laurence

Proceedings of the National Academy of Sciences of the United States of America

2022 Volume 119, Issue 23, Page(s) e2119266119

Abstract: The effectiveness of mask wearing at controlling severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission has been unclear. While masks are known to substantially reduce disease transmission in healthcare settings [D. K. Chu et al., ... ...

Abstract	The effectiveness of mask wearing at controlling severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission has been unclear. While masks are known to substantially reduce disease transmission in healthcare settings [D. K. Chu et al., Lancet 395, 1973–1987 (2020); J. Howard et al., Proc. Natl. Acad. Sci. U.S.A. 118, e2014564118 (2021); Y. Cheng et al., Science eabg6296 (2021)], studies in community settings report inconsistent results [H. M. Ollila et al., medRxiv (2020); J. Brainard et al., Eurosurveillance 25, 2000725 (2020); T. Jefferson et al., Cochrane Database Syst. Rev. 11, CD006207 (2020)]. Most such studies focus on how masks impact transmission, by analyzing how effective government mask mandates are. However, we find that widespread voluntary mask wearing, and other data limitations, make mandate effectiveness a poor proxy for mask-wearing effectiveness. We directly analyze the effect of mask wearing on SARS-CoV-2 transmission, drawing on several datasets covering 92 regions on six continents, including the largest survey of wearing behavior (n= 20 million) [F. Kreuter et al., https://gisumd.github.io/COVID-19-API-Documentation (2020)]. Using a Bayesian hierarchical model, we estimate the effect of mask wearing on transmission, by linking reported wearing levels to reported cases in each region, while adjusting for mobility and nonpharmaceutical interventions (NPIs), such as bans on large gatherings. Our estimates imply that the mean observed level of mask wearing corresponds to a 19% decrease in the reproduction number R. We also assess the robustness of our results in 60 tests spanning 20 sensitivity analyses. In light of these results, policy makers can effectively reduce transmission by intervening to increase mask wearing.
MeSH term(s)	COVID-19/epidemiology ; COVID-19/prevention & control ; Humans ; Masks ; Public Policy ; Surveys and Questionnaires
Language	English
Publishing date	2022-05-31
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, P.H.S. ; Research Support, Non-U.S. Gov't
ZDB-ID	209104-5
ISSN	1091-6490 ; 0027-8424
ISSN (online)	1091-6490
ISSN	0027-8424
DOI	10.1073/pnas.2119266119
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Article ; Online: Seasonal variation in SARS-CoV-2 transmission in temperate climates

Gavenciak, Tomas / Monrad, Joshua Teperowski / Leech, Gavin / Sharma, Mrinank / Mindermann, Soren / Brauner, Jan Markus / Bhatt, Samir / Kulveit, Jan

medRxiv

Abstract: While seasonal variation has a known influence on the transmission of several respiratory viral infections, its role in SARS-CoV-2 transmission remains unclear. As previous analyses have not accounted for the implementation of non-pharmaceutical ... ...

Abstract	While seasonal variation has a known influence on the transmission of several respiratory viral infections, its role in SARS-CoV-2 transmission remains unclear. As previous analyses have not accounted for the implementation of non-pharmaceutical interventions (NPIs) in the first year of the pandemic, they may yield biased estimates of seasonal effects. Building on two state-of-the-art observational models and datasets, we adapt a fully Bayesian method for estimating the association between seasonality and transmission in 143 temperate European regions. We find strong seasonal patterns, consistent with a reduction in the time-variable Rt of 42.1% (95% CI: 24.7% - 53.4%) from the peak of winter to the peak of summer. These results imply that the seasonality of SARS-CoV-2 transmission is comparable in magnitude to the most effective individual NPIs but less than the combined effect of multiple interventions.
Keywords	covid19
Language	English
Publishing date	2021-06-13
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2021.06.10.21258647
Database	COVID19

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