Background: “Vaccine hesitancy” has been described as a major public health problem, especially in the COVID-19 era. Identified factors driving “hesitancy” include the concerns of recipients with the safety, side effects, and risk-benefit ratio of COVID-19 vaccines[1] — a proper assessment and disclosure of which are critical to the requisite process of informed consent. However, the expert literature has given little attention to the evidence informing these concerns, focusing instead on features of the recipients themselves to explain the phenomenon of so-called “hesitancy”. Goal: This umbrella review will expand the scope of research on “vaccine hesitancy” by examining how the safety, side effects, and risk-benefit ratio concerns of recipients of COVID-19 vaccines are addressed in the expert literature. Inclusion criteria: We will include systematic reviews on COVID-19 “vaccine hesitancy” that examine hesitancy in any population involved with COVID-19 vaccination decisions for themselves or as caretakers (e.g., decisions about “vaccinating” their children) to capture the broadest possible range of perspectives on the phenomenon of interest. Only completed, published, and refereed systematic reviews in English will be included. Methods: We will search PubMed, the Epistemonokos COVID-19 platform (COVID-19 L·OVE), and the WHO Global Research on COVID-19 Database to locate quantitative, qualitative, and mixed methods studies reviews. Reviews that meet the inclusion criteria will undergo quality assessment (AMSTAR) and data extraction. Two reviewers will independently conduct title and abstract screening and extract and synthesize the data. Disagreements will be resolved through full team discussion. Subgroup analyses will be performed to compare findings according to social indicators of target populations, country location of the first author, and other contextual factors. Thematic analysis and synthesis will be used to “transform the data” into themes by applying a deductive-inductive approach. Frequency distributions will be calculated to assess the strength of support for each theme. Findings will be presented in tabular and narrative forms to facilitate their interpretation. Significance: Informed consent is a fundamental bioethical principle in medical research and practice. Insufficient attention to the concerns of vaccine recipients about these matters, compounded by a neglect to discuss the evidence-base informing these concerns, may contribute to the very problem that the COVID-19 “vaccine hesitancy” expert literature purports to address. This is especially true of an intervention based on novel technologies and intended to be delivered on a global scale. Identifying if and how the expert literature engages with these concerns is critical. Systematic review registration: PROSPERO CRD42022351489. [1] Although we use the phrase “COVID-19 vaccines” throughout, we believe they should more appropriately be referred to as “COVID-19 genetic vaccines”, “COVID-19 injections”, or "mRNA biologicals”. However, we have chosen “vaccine” with no quotation marks for better readability. For an in-depth discussion of this issue, see Rose (2021).
“Vaccine hesitancy” has been described as a major public health problem, especially in the COVID-19 era. Identified factors driving “hesitancy” include the concerns of recipients with the safety, side effects, and risk-benefit ratio of COVID-19 vaccines1 — a proper assessment and disclosure of which are critical to the requisite process of informed consent. However, the expert literature has given little attention to the evidence informing these concerns, focusing instead on features of the recipients themselves to explain the phenomenon of so-called “hesitancy”. This umbrella review will expand the scope of research on “vaccine hesitancy” by examining how the safety, side effects, and risk-benefit ratio concerns of recipients of COVID-19 vaccines are addressed in the expert literature. We will include systematic reviews on COVID-19 “vaccine hesitancy” that examine hesitancy in any population involved with COVID-19 vaccination decisions for themselves or as caretakers (e.g., decisions about “vaccinating” their children) to capture the broadest possible range of perspectives on the phenomenon of interest. Only completed, published, and refereed systematic reviews in English will be included. We will search PubMed, the Epistemonikos COVID-19 platform (COVID-19 L·OVE), and the WHO Global Research on COVID-19 Database to locate quantitative, qualitative, and mixed methods studies reviews. Reviews that meet the inclusion criteria will undergo quality assessment (AMSTAR) and data extraction. Two reviewers will independently conduct title and abstract screening and extract and synthesize the data. Disagreements will be resolved through full team discussion. Subgroup analyses will be performed to compare findings according to social indicators of target populations, country location of the first author, and other contextual factors. Thematic analysis and synthesis will be used to “transform the data” into themes by applying a deductive-inductive approach. Frequency distributions will be calculated to assess the strength of support for each theme. Findings will be presented in tabular and narrative forms to facilitate their interpretation. Informed consent is a fundamental bioethical principle in medical research and practice. Insufficient attention to the concerns of vaccine recipients about these matters, compounded by a neglect to discuss the evidence-base informing these concerns, may contribute to the very problem that the COVID-19 “vaccine hesitancy” expert literature purports to address. This is especially true of an intervention based on novel technologies and intended to be delivered on a global scale. Identifying if and how the expert literature engages with these concerns is critical.
Background: “Vaccine hesitancy” (VH) has been described as a “threat to global health”, especially in the COVID-19 era. Research on VH indicates that the concerns of vaccine recipients with the balance of risks and benefits of COVID-19 vaccination, which involve safety and effectiveness considerations (hereafter “safety concerns”), are a leading driver of VH. However, what explains these concerns is underexplored. Goal: We conducted a qualitative umbrella review following PRISMA guidelines and informed by a critical perspective to examine how the safety concerns of COVID-19 vaccine recipients are addressed in the VH literature. Methods: We searched PubMed, the Epistemonikos COVID-19 platform (COVID-19 L. OVE), and the WHO Global Research on COVID-19 Database. We included 49 refereed reviews examining VH in any population involved with COVID-19 vaccination decisions for themselves or as caretakers, with no methodological, quality, temporal, or geographic restrictions, and were published in English, excluding those that authors did not identify as “systematic”. Two reviewers completed article screening and data extraction and synthesis. Thematic synthesis was used to identify themes and frequencies were calculated to assess the strength of support for themes. Disagreements were resolved through full team discussion. The protocol was registered with PROSPERO (ID CRD42022351489) and partially funded by a SSHRC grant (# 435-2022-0959).Findings: All reviews assumed that VH was a major barrier to ending the COVID-19 crisis. With vaccines assumed to be “safe and effective”, recipients’ safety concerns were downplayed. Evidence incompatible with “VH-as-a-problem”, whenever mentioned, was dismissed as “misinformation”. Informed consent was either not discussed or was presented as a potential threat to “vaccine confidence”. We observed no differences regardless of study population, methodology, or other study characteristics. Limitations are discussed. Conclusions: Neglecting or dismissing vaccine recipients’ safety concerns contributes to the problem that research on COVID-19 VH purports to address. It also undermines the implementation of informed consent, critical to ethical medical and public health research, policy, and practice. The scant attention to bioethical considerations in current COVID-19 VH research is concerning.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.