A research and development (R&D) roadmap for broadly protective coronavirus vaccines: A pandemic preparedness strategy.

Broadly protective coronavirus vaccines are an important tool for protecting against future SARS-CoV-2 variants and could play a critical role in mitigating the impact of future outbreaks or pandemics caused by novel coronaviruses. The Coronavirus Vaccines Research and Development (R&D) Roadmap (CVR) is aimed at promoting the development of such vaccines. The CVR, funded by the Bill & Melinda Gates Foundation and The Rockefeller Foundation, was generated through a collaborative and iterative process, which was led by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and involved 50 international subject matter experts and recognized leaders in the field. This report summarizes the major issues and areas of research outlined in the CVR and identifies high-priority milestones. The CVR covers a 6-year timeframe and is organized into five topic areas: virology, immunology, vaccinology, animal and human infection models, and policy and finance. Included in each topic area are key barriers, gaps, strategic goals, milestones, and additional R&D priorities. The roadmap includes 20 goals and 86 R&D milestones, 26 of which are ranked as high priority. By identifying key issues, and milestones for addressing them, the CVR provides a framework to guide funding and research campaigns that promote the development of broadly protective coronavirus vaccines.

Applications of an Equity Framework in COVID-19 Vaccine Trial and Distribution Planning.

There are a disproportionate number of cases, hospitalizations, and deaths among Black and Latinx communities, a result of a history of structural racism and exploitation. An equity framework and approach are critical but have been lacking in the COVID-19 response, including vaccine dissemination. We provide an overview and application of remove, repair, remediate, restructure, and provide (R4P), an equity framework, in examining COVID-19 vaccine trial development and related interventions. R4P is an equity framework and tool that applies critical race theory, intersectional, and dimensionality in planning, assessment, and research for creating action to eliminate inequities.

Willingness to Accept Expedited COVID-19 Vaccine Research for Children Aged <12 Years After Adult Vaccine Approval.

PURPOSE: The goal of this study was to assess if caregivers' attitudes toward the regulatory process of approving the vaccine against coronavirus disease 2019 (COVID-19) for children aged <12 years changed after a vaccine was approved for adults. METHODS: This was a larger scale COVIPAS (COVID-19 Parental Attitude Study) survey of caregivers presenting with their children aged ≤12 years for emergency care in 12 hospitals in the United States, Canada, and Israel. The study compared willingness to support abridged research into COVID-19 vaccines for children between the peak of the pandemic (March-May 2020) and after a COVID-19 vaccine became available for adults (December 2020-March 2021). FINDINGS: A total of 1956 surveys were included in the analyses. Overall, 385 (30.9%) caregivers in the pre-vaccine approval period and 250 (35.3%) caregivers in the post-adult vaccine phase supported abridged research into COVID-19 vaccines (P < 0.001). In both phases, mothers were less likely to favor abridged approval. Those with children who were fully vaccinated based on the pediatric schedule in their country favored abridged approval in phase 1 (odds ratio, 1.98; 95% confidence interval, 1.31-3.08) but less so in phase 2. In both phases, age and concerns of parents that they had COVID-19 or their child had COVID-19 were not associated with changes in response between phases. IMPLICATIONS: Willingness to expedite vaccine approval increased after the emergency approval of COVID-19 vaccine for adults. Mothers are much less likely to approve expedited approval. No significant changes have been found in the composition of caregivers willing to forego regulatory demands on vaccine approval.

Empowering Equitable Data Use Partnerships and Indigenous Data Sovereignties Amid Pandemic Genomics.

The COVID-19 pandemic has inequitably impacted Indigenous communities in the United States. In this emergency state that highlighted existing inadequacies in US government and tribal public health infrastructures, many tribal nations contracted with commercial entities and other organization types to conduct rapid diagnostic and antibody testing, often based on proprietary technologies specific to the novel pathogen. They also partnered with public-private enterprises on clinical trials to further the development of vaccines. Indigenous people contributed biological samples for assessment and, in many cases, broadly consented for indefinite use for future genomics research. A concern is that the need for crisis aid may have placed Indigenous communities in a position to forego critical review of data use agreements by tribal research governances. In effect, tribal nations were placed in the unenviable position of trading short-term public health assistance for long-term, unrestricted access to Indigenous genomes that may disempower future tribal sovereignties over community members' data. Diagnostic testing, specimen collection, and vaccine research is ongoing; thus, our aim is to outline pathways to trust that center current and future equitable relationship-building between tribal entities and public-private interests. These pathways can be utilized to increase Indigenous communities' trust of external partners and share understanding of expectations for and execution of data protections. We discuss how to navigate genomic-based data use agreements in the context of pathogen genomics. While we focus on US tribal nations, Indigenous genomic data sovereignties relate to global Indigenous nations regardless of colonial government recognition.

Lessons Learned from Cutting-Edge Immunoinformatics on Next-Generation COVID-19 Vaccine Research.

Presently, immunoinformatics and bioinformatics approaches are contributing actively to COVID-19 vaccine research. The first immunoinformatics-based vaccine construct against SARS-CoV-2 was published in February 2020. Following this, immunoinformatics and bioinformatics approaches have created a new direction in COVID-19 vaccine research. Several researchers have designed the next-generation COVID-19 vaccines using these approaches. Presently, immunoinformatics has accelerated immunology research immensely in the area of COVID-19. Hence, we have tried to depict the current scenario of immunoinformatics and bioinformatics in COVID-19 vaccine research. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10989-021-10254-4.

3D printing technologies for in vitro vaccine testing platforms and vaccine delivery systems against infectious diseases.

Recent advances in 3D printing (3DP) and tissue engineering approaches enable the potential application of these technologies to vaccine research. Reconstituting the native tissue or cellular microenvironment will be vital for successful evaluation of pathogenicity of viral infection and screening of potential vaccines. Therefore, establishing a reliable in vitro model to study the vaccine efficiency or delivery of viral disease is important. Here, this review summarizes two major ways that tissue engineering and 3DP strategies could contribute to vaccine research: (1) 3D human tissue models to study the response to virus can be served as a testbed for new potential therapeutics. Using 3D tissue platform attempts to explore alternative options to pre-clinical animal research for evaluating vaccine candidates. (2) 3DP technologies can be applied to improve the vaccination strategies which could replace existing vaccine delivery. Controlled antigen release using carriers that are generated with biodegradable biomaterials can further enhance the efficient development of immunity as well as combination of multiple-dose vaccines into a single injection. This mini review discusses the up-to-date report of current 3D tissue/organ models for potential vaccine potency and known bioengineered vaccine delivery systems.

Emergency use of COVID-19 vaccines recommended by the World Health Organization (WHO) as of June 2021.

In December 2019, the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused the outbreak of coronavirus disease 2019 (COVID-19), and the resulting pandemic has caused widespread health problems and social and economic disruption. Thus far in 2021, more than 4 million people worldwide have died from COVID-19, so safe and efficacious vaccines are urgently needed to restore normal economic and social activities. According to the official guidance documents of the World Health Organization (WHO), vaccines based on four major strategies including mRNA, adenoviral vectors, inactivated viruses, and recombinant proteins have entered the stage of emergency use authorization and pre-certification evaluation. The current review summarizes these vaccines and it looks ahead to the development of additional COVID-19 vaccines in the future.

COVID-19 vaccine research and development: ethical issues.

The achievements of vaccine research and development bring a hope to our societies that we may cope with the COVID-19 pandemic. There are two aspects that should be maintained in balance: the immediate necessity for speed of vaccine research and the inherent need for protection of research subjects, which is the foremost concern of research ethics. This narrative review highlights ethical issues in COVID-19 vaccine research and development that every stakeholder needs to be aware of and to consider.

Pregnant women's perceptions of risks and benefits when considering participation in vaccine trials.

INTRODUCTION: Despite historical exclusion, there has been recent recognition of the need to address the health of pregnant women in research on vaccines against emerging pathogens. However, pregnant women's views and decision-making processes about vaccine research participation during infectious disease outbreaks remain underexplored. This study aims to examine women's decision-making processes around vaccine research participation during infectious disease outbreaks. METHODS: We conducted qualitative semi-structured in-depth interviews with pregnant and recently pregnant women (n = 13), eliciting their views on four hypothetical Zika Virus vaccine research scenarios and probing their decision-making processes around participation. After recorded interviews were transcribed, thematic analysis was conducted based on a priori and emergent themes. RESULTS: Most women interviewed were accepting of vaccine research scenarios. Three broad themes-evidence, risk, and trust-characterized women's decision-making processes. Women varied in how different types and levels of evidence impacted their considerations, which risks were most salient to their decision-making processes, and from whom they trusted recommendations about vaccine research participation. Exemplary quotes from each theme are presented, and lessons for vaccine development during the current COVID-19 pandemic and future outbreaks are discussed. CONCLUSION: Some pregnant women are accepting of participation in vaccine research during infectious disease outbreaks. Incorporating their priorities into trial design may facilitate their participation and generation of evidence for this important population.