Dataset Information

Broad cross-national public support for accelerated COVID-19 vaccine trial designs.

ABSTRACT: A vaccine for COVID-19 is urgently needed. Several vaccine trial designs may significantly accelerate vaccine testing and approval, but also increase risks to human subjects. Concerns about whether the public would see such designs as ethical represent an important roadblock to their implementation; accordingly, both the World Health Organization and numerous scholars have called for consulting the public regarding them. We answered these calls by conducting a cross-national survey (n = 5920) in Australia, Canada, Hong Kong, New Zealand, South Africa, Singapore, the United Kingdom, and the United States. The survey explained key differences between traditional vaccine trials and two accelerated designs: a challenge trial or a trial integrating a Phase II safety and immunogenicity trial into a larger Phase III efficacy trial. Respondents' answers to comprehension questions indicate that they largely understood the key differences and ethical trade-offs between the designs from our descriptions. We asked respondents whether they would prefer scientists to conduct traditional trials or one of these two accelerated designs. We found broad majorities prefer for scientists to conduct challenge trials (75%) and integrated trials (63%) over standard trials. Even as respondents acknowledged the risks, they perceived both accelerated trials as similarly ethical to standard trial designs. This high support is consistent across every geography and demographic subgroup we examined, including vulnerable populations. These findings may help assuage some of the concerns surrounding accelerated designs.

SUBMITTER: Broockman D

PROVIDER: S-EPMC7831807 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Broad cross-national public support for accelerated COVID-19 vaccine trial designs.

Broockman David D Kalla Joshua J Guerrero Alexander A Budolfson Mark M Eyal Nir N Jewell Nicholas P NP Magalhaes Monica M Sekhon Jasjeet S JS

Vaccine 20201214 2

A vaccine for COVID-19 is urgently needed. Several vaccine trial designs may significantly accelerate vaccine testing and approval, but also increase risks to human subjects. Concerns about whether the public would see such designs as ethical represent an important roadblock to their implementation; accordingly, both the World Health Organization and numerous scholars have called for consulting the public regarding them. We answered these calls by conducting a cross-national survey (n = 5920) in ...[more]

PMID: 33334616

Similar Datasets

Project description:ImportanceAs COVID-19 vaccine distribution continues, policy makers are struggling to decide which groups should be prioritized for vaccination.ObjectiveTo assess US adults' preferences regarding COVID-19 vaccine prioritization.Design, setting, and participantsThis survey study involved 2 independent, online surveys of US adults aged 18 years and older, 1 conducted by Gallup from September 14 to 27, 2020, and the other conducted by the COVID Collaborative from September 19 to 25, 2020. Samples were weighted to reflect sociodemographic characteristics of the US population.ExposuresRespondents were asked to prioritize groups for COVID-19 vaccine and to rank their prioritization considerations.Main outcomes and measuresThe study assessed prioritization preferences and agreement with the National Academies of Science, Engineering, and Medicine's Preliminary Framework for Equitable Allocation of COVID-19 Vaccine.ResultsA total of 4735 individuals participated, 2730 (1474 men [54.1%]; mean [SD] age, 59.2 [14.5] years) in the Gallup survey and 2005 (944 men [47.1%]; 203 participants [21.5%] aged 55-59 years) in the COVID Collaborative survey. In both the Gallup COVID-19 Panel and COVID Collaborative surveys, respondents listed health care workers (Gallup, 93.6% [95% CI, 91.2%-95.3%]; COVID Collaborative, 80.0% [95% CI, 78.0%-81.9%]) and adults of any age with serious comorbid conditions (Gallup, 78.6% [95% CI, 75.2%-81.7%]; COVID Collaborative, 72.9% [95% CI, 70.7%-74.9%]) among their 4 highest priority groups. Respondents of all political affiliations agreed with prioritizing Black, Hispanic, Native American, and other communities that have been disproportionately affected by COVID-19 (Gallup, 74.2% [95% CI, 70.6%-77.5%]; COVID Collaborative, 84.9% [95% CI, 83.1%-86.5%]), and COVID Collaborative respondents were willing to be preceded in line by teachers and childcare workers (92.5%; 95% CI, 91.2%-93.7%) and grocery workers (85.9%; 95% CI, 84.2%-87.5%). Older respondents in both surveys were significantly less likely than younger respondents to prioritize healthy adults aged 65 years and older among their 4 highest priority groups (Gallup, 23.7% vs 39.1% [χ2 = 2160.8; P < .001]; COVID Collaborative, 23.3% vs 28.8% [χ2 = 5.0198; P = .03]). COVID Collaborative respondents believed the 4 most important considerations for prioritization were preventing COVID-19 spread (78.4% [95% CI, 76.3%-80.3%]), preventing the most deaths (72.1% [95% CI, 69.9%-74.2%]), preventing long-term complications (68.9% [66.6%-71.9%]), and protecting frontline workers (63.8% [95% CI, 61.5%-66.1%]).Conclusions and relevanceUS adults broadly agreed with the National Academies of Science, Engineering, and Medicine's prioritization framework. Respondents endorsed prioritizing racial/ethnic communities that are disproportionately affected by COVID-19, and older respondents were significantly less likely than younger respondents to endorse prioritizing healthy people older than 65 years. This provides reason for caution about COVID-19 vaccine distribution plans that prioritize healthy adults older than a cutoff age without including those younger than that age with preexisting conditions, that aim solely to prevent the most deaths, or that give no priority to frontline workers or disproportionately affected communities.

Project description:In the last two years, the coronavirus disease 19 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a scientific and social challenge worldwide. Vaccines have been the most effective intervention for reducing virus transmission and disease severity. However, virus genetic variants are still circulating among vaccinated individuals with different symptomatology disease cases. Understanding the protective or disease associated mechanisms in vaccinated individuals is relevant to advance in vaccine development and implementation. To address this objective, serum protein profiles were characterized by quantitative proteomics and data analysis algorithms in four cohorts of vaccinated individuals uninfected and SARS-CoV-2 infected with asymptomatic, nonsevere and severe disease symptomatology. The results showed that immunoglobulins were the most overrepresented proteins in infected cohorts when compared to PCR-negative individuals. The immunoglobulin profile varied between different infected cohorts and correlated with protective or disease associated capacity. Overrepresented immunoglobulins in PCR-positive individuals correlated with protective response against SARS-CoV-2, other viruses, and thrombosis in asymptomatic cases. In nonsevere cases, correlates of protection against SARS-CoV-2 and HBV together with risk of myasthenia gravis and allergy and autoantibodies were observed. Patients with severe symptoms presented risk for allergy, chronic idiopathic thrombocytopenic purpura, and autoantibodies. The analysis of underrepresented immunoglobulins in PCR-positive compared to PCR-negative individuals identified vaccine-induced protective epitopes in various coronavirus proteins including the Spike receptor-binding domain RBD. Non-immunoglobulin proteins were associated with COVID-19 symptoms and biological processes. These results evidence host-associated differences in response to vaccination and the possibility of improving vaccine efficacy against SARS-CoV-2.

Project description:BackgroundMany high-income countries (HICs) have now vaccinated a substantial proportion of their population against COVID-19. Many low-income countries (LICs) may need to wait until at least 2022 before even the most vulnerable 20% of their populations are vaccinated. Beyond ethical considerations, some redistribution of doses would reduce the risk of the emergence and spread of new variants and benefit the economy, both globally and in donor countries. However, the willingness of HIC governments to donate vaccine doses is likely to depend on public support. While previous work has indicated strong average levels of public support in HIC for donation, little is known about how broad-based this support is.ObjectiveTo investigate the extent to which support for donation holds across both pre-specified and exploratory subgroups.MethodsFrom 24 November-28 December 2020 we conducted an online survey of 8209 members of the general public in seven HIC (Australia, Canada, France, Italy, Spain, UK and USA). We conducted tests of proportions and used Bayesian ordinal logistic regression models to assess the extent of support for donation across population subgroups.ResultsWe found broad-based support for donations in terms of age, gender, socio-economic status and political ideology. We found no strong evidence that support for donations was higher among those with greater income or a university education. Support for donation among those on the political right and centre was lower than on the left, but 51% (95% confidence interval 48-53%) of respondents who identified with the right supported some level of donation. Those in the more altruistic half of the sample (as captured by willingness to donate money to a good cause) were more likely to support donation than those who were not, but around half of the less altruistic group supported some level of donation.ConclusionThere is broad-based support for policymakers in HICs to donate some of their countries' COVID-19 vaccine doses for distribution to LICs.

Dataset Information

Broad cross-national public support for accelerated COVID-19 vaccine trial designs.

Publications

Broad cross-national public support for accelerated COVID-19 vaccine trial designs.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets