COVID-19 Vaccines Development/Distribution – Ethical Considerations

COVID-19 Vaccines Development/Distribution – Ethical Considerations

Vaccine
Volume 38, Issue 41 Pages 6347-6484 (22 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/41
Review article Full text access
So much at stake: Ethical tradeoffs in accelerating SARSCoV-2 vaccine development
Christine Grady, Seema Shah, Franklin Miller, Marion Danis, … Annette Rid
Pages 6381-6387
Abstract
Background
A sense of urgency exists to develop vaccines against SARS CoV-2, responsible for numerous global cases and deaths, as well as widespread social and economic disruption. Multiple approaches have been proposed to speed up vaccine development, including accelerated randomized controlled trials (RCT), controlled human challenge trials (CHI), and wide distribution through an emergency use authorization after collecting initial data. There is a need to examine how best to accelerate vaccine development in the setting of a pandemic, without compromising ethical and scientific norms.
Methods
Trade-offs in scientific and social value between generating reliable evidence about safety and efficacy while promoting rapid vaccine availability are examined along five ethically relevant dimensions: (1) confidence in and generalizability of data, (2) feasibility, (3) speed and cost, (4) participant risks, and (5) social risks.
Results
Accelerated individually randomized RCTs permit expeditious evaluation of vaccine candidates using established methods, expertise, and infrastructure. RCTs are more likely than other approaches to be feasible, increase speed and reduce cost, and generate reliable data about safety and efficacy without significantly increasing risks to participants or undermining societal trust.
Conclusion
Ethical analysis suggests that accelerated RCTs are the best approach to accelerating vaccine development in a pandemic, and more likely than other approaches to enhance social value without compromising ethics or science. RCTs can expeditiously collect rigorous data about vaccine safety and efficacy. Innovative and flexible designs and implementation strategies to respond to shifting incidence and test vaccine candidates in parallel or sequentially would add value, as will coordinated data sharing across vaccine trials. CHI studies may be an important complementary strategy when more is known. Widely disseminating a vaccine candidate without efficacy data will not serve the public health nor achieve the goal of identifying safe and effective SARS Co-V-2 vaccines.

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Science
11 September 2020 Vol 369, Issue 6509
http://www.sciencemag.org/current.dtl
Policy Forum
An ethical framework for global vaccine allocation
By Ezekiel J. Emanuel, Govind Persad, Adam Kern, Allen Buchanan, Cécile Fabre, Daniel Halliday, Joseph Heath, Lisa Herzog, R. J. Leland, Ephrem T. Lemango, Florencia Luna, Matthew S. McCoy, Ole F. Norheim, Trygve Ottersen, G. Owen Schaefer, Kok-Chor Tan, Christopher Heath Wellman, Jonathan Wolff, Henry S. Richardson
Science11 Sep 2020 : 1309-1312
The Fair Priority Model offers a practical way to fulfill pledges to distribute vaccines fairly and equitably
Summary
Once effective coronavirus disease 2019 (COVID-19) vaccines are developed, they will be scarce. This presents the question of how to distribute them fairly across countries. Vaccine allocation among countries raises complex and controversial issues involving public opinion, diplomacy, economics, public health, and other considerations. Nevertheless, many national leaders, international organizations, and vaccine producers recognize that one central factor in this decision-making is ethics (1, 2). Yet little progress has been made toward delineating what constitutes fair international distribution of vaccine. Many have endorsed “equitable distribution of COVID-19…vaccine” without describing a framework or recommendations (3, 4). Two substantive proposals for the international allocation of a COVID-19 vaccine have been advanced, but are seriously flawed. We offer a more ethically defensible and practical proposal for the fair distribution of COVID-19 vaccine: the Fair Priority Model.

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COVID-19 Vaccines Development/Distribution – Ethical Considerations

 

Vaccine
Volume 38, Issue 41 Pages 6347-6484 (22 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/41
Review article Full text access
So much at stake: Ethical tradeoffs in accelerating SARSCoV-2 vaccine development
Christine Grady, Seema Shah, Franklin Miller, Marion Danis, … Annette Rid
Pages 6381-6387
Abstract
Background
A sense of urgency exists to develop vaccines against SARS CoV-2, responsible for numerous global cases and deaths, as well as widespread social and economic disruption. Multiple approaches have been proposed to speed up vaccine development, including accelerated randomized controlled trials (RCT), controlled human challenge trials (CHI), and wide distribution through an emergency use authorization after collecting initial data. There is a need to examine how best to accelerate vaccine development in the setting of a pandemic, without compromising ethical and scientific norms.
Methods
Trade-offs in scientific and social value between generating reliable evidence about safety and efficacy while promoting rapid vaccine availability are examined along five ethically relevant dimensions: (1) confidence in and generalizability of data, (2) feasibility, (3) speed and cost, (4) participant risks, and (5) social risks.
Results
Accelerated individually randomized RCTs permit expeditious evaluation of vaccine candidates using established methods, expertise, and infrastructure. RCTs are more likely than other approaches to be feasible, increase speed and reduce cost, and generate reliable data about safety and efficacy without significantly increasing risks to participants or undermining societal trust.
Conclusion
Ethical analysis suggests that accelerated RCTs are the best approach to accelerating vaccine development in a pandemic, and more likely than other approaches to enhance social value without compromising ethics or science. RCTs can expeditiously collect rigorous data about vaccine safety and efficacy. Innovative and flexible designs and implementation strategies to respond to shifting incidence and test vaccine candidates in parallel or sequentially would add value, as will coordinated data sharing across vaccine trials. CHI studies may be an important complementary strategy when more is known. Widely disseminating a vaccine candidate without efficacy data will not serve the public health nor achieve the goal of identifying safe and effective SARS Co-V-2 vaccines.

 

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Science
11 September 2020 Vol 369, Issue 6509
http://www.sciencemag.org/current.dtl
Policy Forum
An ethical framework for global vaccine allocation
By Ezekiel J. Emanuel, Govind Persad, Adam Kern, Allen Buchanan, Cécile Fabre, Daniel Halliday, Joseph Heath, Lisa Herzog, R. J. Leland, Ephrem T. Lemango, Florencia Luna, Matthew S. McCoy, Ole F. Norheim, Trygve Ottersen, G. Owen Schaefer, Kok-Chor Tan, Christopher Heath Wellman, Jonathan Wolff, Henry S. Richardson
Science11 Sep 2020 : 1309-1312
The Fair Priority Model offers a practical way to fulfill pledges to distribute vaccines fairly and equitably
Summary
Once effective coronavirus disease 2019 (COVID-19) vaccines are developed, they will be scarce. This presents the question of how to distribute them fairly across countries. Vaccine allocation among countries raises complex and controversial issues involving public opinion, diplomacy, economics, public health, and other considerations. Nevertheless, many national leaders, international organizations, and vaccine producers recognize that one central factor in this decision-making is ethics (1, 2). Yet little progress has been made toward delineating what constitutes fair international distribution of vaccine. Many have endorsed “equitable distribution of COVID-19…vaccine” without describing a framework or recommendations (3, 4). Two substantive proposals for the international allocation of a COVID-19 vaccine have been advanced, but are seriously flawed. We offer a more ethically defensible and practical proposal for the fair distribution of COVID-19 vaccine: the Fair Priority Model.