Estruturação do plano de imunização no combate a covid-19: (des)ordem nos acordos entre os poderes / Structuring the immunization plan to fight covid-19: (dis)order in agreements between the powers / Estructura del plan de inmunización para combatir el covid-19: (des)orden en acuerdos entre potencias

Objetivo: Fomentar o debate acerca da ordenação do plano de vacinação nacional, considerando os aspectos organizacionais entre união, estados e municípios. Métodos: Revisão de literatura, tendo como base os periódicos Cientific Electronic Library Online (SCIELO), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) e Biblioteca Virtual de Saúde (BVS), usando como descritores: Pandemia, Vacina e Plano de Imunização. Com essa busca foram encontradas, inicialmente, 48 publicações. Após a realização da análise, foram incluídos 11 artigos científicos na revisão. Os textos foram submetidos à análise de conteúdo semântica. Resultados: Foram levantadas duas categorias: estratégias de combate a pandemia do covid-19 no Brasil, e a manipulação da sociedade civil e a desordem da cobertura vacinal. Conclusão: as reflexões aqui apresentadas podem contribuir para que os profissionais de enfermagem desenvolvam uma postura reflexiva frente a demanda vacinal, processo de planejamento e percepções da sociedade civil, podendo desencadear uma melhora na preparação para a educação em saúde. (AU)

Objective: To encourage the debate about the ordering of the national vaccination plan, considering the organizational aspects between the union, states and municipalities. Methods: Literature review, based on scientific journals Electronic Library Online (SCIELO), Coordination for the Improvement of Higher Education Personnel (CAPES) and Virtual Health Library (VHL), using as descriptors: Pandemia, Vaccine and Immunization Plan. With this search, 48 publications were initially found. After the analysis, 11 scientific articles were included in the review. The texts were subjected to semantic content analysis. Results: Two categories were raised: strategies to combat the covid-19 pandemic in Brazil, and the manipulation of civil society and the disorder of vaccination coverage. Conclusion: The reflections presented here can contribute for nursing professionals to develop a reflexive posture in face of the vaccine demand, planning process and civil society perceptions, which can trigger an improvement in the preparation for health education. (AU)

Objetivo: Fomentar el debate sobre la ordenación del plan nacional de vacunación, considerando los aspectos organizativos entre sindicato, estados y municipios. Métodos: Revisión de la literatura, con base en revistas científicas Biblioteca Electrónica en Línea (SCIELO), Coordinación para el Perfeccionamiento del Personal de Educación Superior (CAPES) y Biblioteca Virtual en Salud (BVS), utilizando como descriptores: Pandemia, Vacuna y Plan de Inmunización. Con esta búsqueda se encontraron inicialmente 48 publicaciones. Después del análisis, se incluyeron 11 artículos científicos en la revisión. Los textos fueron sometidos a análisis de contenido semántico. Resultados: Se plantearon dos categorías: estrategias para combatir la pandemia de covid-19 en Brasil y la manipulación de la sociedad civil y el desorden de la cobertura de vacunación. Conclusión: Las reflexiones aquí presentadas pueden contribuir para que los profesionales de enfermería desarrollen una postura reflexiva ante la demanda de vacunas, el proceso de planificación y las percepciones de la sociedad civil, lo que puede desencadenar una mejora en la preparación para la educación en salud. (AU)

Vaccine Development.

This article considers ethical considerations surrounding pediatric vaccine development for pandemic preparedness, examines some historical cases of pediatric vaccines developed during past smallpox, influenza, and 2019 coronavirus disease pandemics, and discusses the current state of vaccine development for pandemic preparedness, including vaccines against smallpox/mpox, influenza, anthrax, and Ebola that are included in the US Strategic National Stockpile and vaccines being developed against priority pathogens identified by the World Health Organization.

Vaccine Confidence as Critical to Pandemic Preparedness and Response.

Vaccine confidence is a belief that vaccines work, are safe, and are part of a trustworthy medical system. The COVID-19 pandemic exposed the fragility of the public's confidence in vaccines and the vaccine enterprise, limiting the public health impact of vaccination. In this review, we examine the critical nature of vaccine confidence to pandemic preparedness and response.

Adult vaccination against respiratory infections in Egypt: a review of expert opinions.

INTRODUCTION: Lower respiratory tract infection is one of the leading causes of morbidity and mortality all over the world, with a substantial impact on healthcare costs. In Egypt, local consensus on its burden, diagnosis, and vaccination is scarce. This expert opinion is the first to address the local recommendations for vaccinating adults against respiratory infection. It sheds light on the growing need to understand the barriers and underpublicized concept of adult vaccination in Egypt. AREAS COVERED: A collaborative multidisciplinary panel from Egypt developed an expert opinion-based suggestions/points, including epidemiology, microbiology, and highlights on vaccination in Egypt, as well as challenges and recommendations regarding adult vaccination. EXPERT OPINION: Adult vaccinations against respiratory infections are now recommended for high-risk people by all healthcare regulatory bodies. However, it was acknowledged that there may be hesitancy and concerns among patients; in addition, healthcare professionals' awareness about vaccination guidelines and benefits needs improvement. There are several strategies that could be implemented to enhance vaccine adherence in Egypt. These approaches encompass conducting community education programs, addressing the concerns of patients, and enhancing awareness among healthcare professionals through education, policy changes, and periodical reminders in each healthcare setting.

Vaccines and the Eye: Current Understanding of the Molecular and Immunological Effects of Vaccination on the Eye.

Vaccination is a public health cornerstone that protects against numerous infectious diseases. Despite its benefits, immunization implications on ocular health warrant thorough investigation, particularly in the context of vaccine-induced ocular inflammation. This review aimed to elucidate the complex interplay between vaccination and the eye, focusing on the molecular and immunological pathways implicated in vaccine-associated ocular adverse effects. Through an in-depth analysis of recent advancements and the existing literature, we explored various mechanisms of vaccine-induced ocular inflammation, such as direct infection by live attenuated vaccines, immune complex formation, adjuvant-induced autoimmunity, molecular mimicry, hypersensitivity reactions, PEG-induced allergic reactions, Type 1 IFN activation, free extracellular RNA, and specific components. We further examined the specific ocular conditions associated with vaccination, such as uveitis, optic neuritis, and retinitis, and discussed the potential impact of novel vaccines, including those against SARS-CoV-2. This review sheds light on the intricate relationships between vaccination, the immune system, and ocular tissues, offering insights into informed discussions and future research directions aimed at optimizing vaccine safety and ophthalmological care. Our analysis underscores the importance of vigilance and further research to understand and mitigate the ocular side effects of vaccines, thereby ensuring the continued success of vaccination programs, while preserving ocular health.

Orientações sobre o uso de vacinas contra a varíola símia. Edição corrigida

A erradicação da varíola humana (mpox em inglês) foi certificada em 1980. A varíola símia (mpox em inglês) é endêmica nos países da África Central e Ocidental desde a sua primeira detecção, em 1958. Trata-se de uma zoonose cujos casos geralmente ocorrem perto de florestas tropicais, onde diversos animais são portadores do ortopoxvírus causador da doença. A maioria das infecções em seres humanos pelo vírus da varíola símia em países onde a doença é endêmica é resultado de transmissão primária de animais para humanos. A transmissão de pessoa a pessoa pode ocorrer por meio de contato próximo com secreções respiratórias ou lesões cutâneas de uma pessoa infectada ou com objetos recém-contaminados. A transmissão também pode ocorrer através da placenta da mãe para o feto ou por contato direto durante ou após o parto. Até 21 de maio de 2022, 12 países onde não há varíola símia endêmica, em 2 regiões da Organização Mundial da Saúde (OMS), haviam notificado 92 casos confirmados da doença. Até 26 de agosto de 2022, 96 países sem endemicidade, de todas as 6 regiões da OMS, haviam notificado 45.198 casos confirmados de varíola símia, incluindo 6 óbitos. No mesmo período, os países onde a doença é endêmica notificaram 350 casos confirmados e 6 óbitos. Na Região das Américas, 29 países e territórios notificaram 23.479 (48%) casos confirmados e 3 óbitos. Diversos estudos observacionais sobre as vacinas de primeira geração demonstraram que a eficácia da vacinação contra a varíola humana na prevenção da varíola símia é de aproximadamente 85%. Atualmente, as vacinas originais (de primeira geração) contra a varíola humana não estão mais disponíveis.

Fluorescent-protein co-expression to select CHO cells expressing high quantities of vaccine antigens.

Cell line development for production of vaccine antigens or therapeutic proteins typically involves transfection, selection, and enrichment for high-expressing cells. Enrichment methods include minipool enrichment, antibody-based enrichment, and enrichment based on co-expressed fluorescent biosensor proteins. However, these methods have limitations regarding labor and cost intensity, the generation of antibodies and assurance of their viral safety, and potential expression-interference or signal-saturation of the co-expressed fluorescent protein. To improve the method of fluorescent-protein co-expression, expression constructs were created that constitutively express a model vaccine antigen together with one of three fluorescent proteins having translation initiation controlled by a wildtype or mutant internal ribosome entry site (IRES), for a total of six constructs. The constructs were transfected into Chinese hamster ovary cells (CHO) cells, enriched for high fluorescence, cultured, and tested in a mini bioreactor to identify the most promising construct. The fluorescent protein, Fluorescent Ubiquitination-based Cell Cycle Indicator (FUCCI) with a mutant IRES performed best and was further tested with three additional vaccine antigens. Across the four vaccine antigens, the FUCCI fluorescent protein yielded productivity enhancements, without the need for generating an antibody and assuring its viral safety. Furthermore, FUCCI protein was present in negligible quantities in the cell supernatant, indicating a low risk for contaminating drug substances or vaccine antigen.

Glycoconjugates: Advances in modern medicines and human health.

Glycans and their glycoconjugates are complex biomolecules that are crucial for various biological processes. Glycoconjugates are found in all domains of life. They are covalently linked to key biomolecules such as proteins and lipids to play a pivotal role in cell signaling, adhesion, and recognition. The diversity of glycan structures and the associated complexity of glycoconjugates is the reason for their role in intricate biosynthetic pathways. Glycoconjugates play an important role in various diseases where they are actively involved in the immune response as well as in the pathogenicity of infectious diseases. In addition, various autoimmune diseases have been linked to glycosylation defects of different biomolecules, making them an important molecule in the field of medicine. The glycoconjugates have been explored for the development of therapeutics and vaccines, representing a breakthrough in medical science. They also hold significance in research studies to understand the mechanisms behind various biological processes. Finally, glycoconjugates have found an emerging role in various industrial and environmental applications which have been discussed here.

Assessment of community pharmacists' knowledge, attitudes and their willingness to provide vaccination services in Saudi Arabia.

BACKGROUND: Community pharmacists play an important role in increasing vaccination rates especially in countries where they offer vaccination services and administration. However, little is known about community pharmacist's willingness to provide vaccination services in Saudi Arabia. The objective of this study was to assess knowledge, attitudes, willingness and beliefs of community pharmacists in Saudi Arabia towards providing vaccines at pharmacies. METHODS: A cross-sectional, online questionnaire-based study using convenience sampling (Snowball technique) was used to obtain responses from community pharmacists across Saudi Arabia. The survey collected information on participants' demographics, knowledge about vaccine, attitude towards vaccine and their attitude to be immunization providers. Bivariate analysis and multiple linear regression models were employed to assess the relationships between demographic variables and outcomes. RESULTS: The study sample consisted of 384 community pharmacists. More than half of participants had poor knowledge about vaccines (54%). Only 8.4% of participants had good knowledge about vaccines. The results indicated that community pharmacists in the study sample have positive attitude toward vaccines and are willing to provide vaccination services. There was a significant relationship between knowledge about vaccine and attitude toward vaccines. Pharmacists with poor knowledge about vaccines had negative attitude toward vaccines as compared to those with high knowledge (ß = -1.743; P-value = 0.024). Additionally, there was a significant relationship between knowledge about vaccine and attitude to be immunization providers. Pharmacists with poor knowledge about vaccines had negative attitude to be immunization providers as compared to those with high knowledge (ß = -2.631; P-value = 0.002). Furthermore, a significant number of the community pharmacists reported facing critical barriers to provide vaccines including legal liability, lack of personal resources and lack of appropriate training. CONCLUSION: Comprehensive training and certification programs for pharmacists are crucial to improve their competencies in handling and administering vaccines to increase the rate of vaccinations in Saudi Arabia.

Microalgae-made human vaccines and therapeutics: A decade of advances.

Microalgal emergence is a promising platform with two-decade historical background for producing vaccines and biopharmaceuticals. During that period, microalgal-based vaccines have reported successful production for various diseases. Thus, species selection is important for genetic transformation and delivery methods that have been developed. Although many vaccine prototypes have been produced for infectious and non-infectious diseases, fewer studies have reached immunological and immunoprotective evaluations. Microalgae-made vaccines for Staphylococcus aureus, malaria, influenza, human papilloma, and Zika viruses have been explored in their capacity to induce humoral or cellular immune responses and protective efficacies against experimental challenges. Therefore, specific pathogen antigens and immune system role are important and addressed in controlling these infections. Regarding non-communicable diseases, these vaccines have been investigated for breast cancer; microalgal-produced therapeutic molecules and microalgal-made interferon-α have been explored for hypertension and potential applications in treating viral infections and cancer, respectively. Thus, conducting immunological trials is emphasized, discussing the promising results observed in terms of immunogenicity, desired immune response for controlling affections, and challenges for achieving the desired protection levels. The potential advantages and hurdles associated with this innovative approach are highlighted, underlining the relevance of assessing immune responses in preclinical and clinical trials to validate the efficacy of these biopharmaceuticals. The promising future of this healthcare technology is also envisaged.

Vaccines as Immunotherapies for Substance Use Disorders.

Substance use disorders (SUD) present a worldwide challenge with few effective therapies except for the relative efficacy of opioid pharmacotherapies, despite limited treatment access. However, the proliferation of illicit fentanyl use initiated a dramatic and cascading epidemic of lethal overdoses. This rise in fentanyl overdoses regenerated an interest in vaccine immunotherapy, which, despite an optimistic start in animal models over the past 50 years, yielded disappointing results in human clinical trials of vaccines against nicotine, stimulants (cocaine and methamphetamine), and opioids. After a brief review of clinical and selected preclinical vaccine studies, the "lessons learned" from the previous vaccine clinical trials are summarized, and then the newest challenge of a vaccine against fentanyl and its analogs is explored. Animal studies have made significant advances in vaccine technology for SUD treatment over the past 50 years, and the resulting anti-fentanyl vaccines show remarkable promise for ending this epidemic of fentanyl deaths.

Identifying factors that can be used to assess a country's readiness to deploy a new vaccine or improve uptake of an underutilised vaccine: a scoping review.

OBJECTIVES: Identifying whether a country is ready to deploy a new vaccine or improve uptake of an existing vaccine requires knowledge of a diverse range of interdependent, context-specific factors. This scoping review aims to identify common themes that emerge across articles, which include tools or guidance that can be used to establish whether a country is ready to deploy a new vaccine or increase uptake of an underutilised vaccine. DESIGN: Scoping review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews guidelines. DATA SOURCES: Embase, CINAHL, Cochrane Library, Google Scholar, MEDLINE, PsycINFO and Web of Science were searched for articles published until 9 September 2023. Relevant articles were also identified through expert opinion. ELIGIBILITY CRITERIA: Articles published in any year or language that included tools or guidance to identify factors that influence a country's readiness to deploy a new or underutilised vaccine. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers screened records and performed data extraction. Findings were synthesised by conducting a thematic analysis. RESULTS: 38 articles met our inclusion criteria; these documents were created using methodologies including expert review panels and Delphi surveys and varied in terms of content and context-of-use. 12 common themes were identified relevant to a country's readiness to deploy a new or underutilised vaccine. These themes were as follows: (1) legal, political and professional consensus; (2) sociocultural factors and communication; (3) policy, guidelines and regulations; (4) financing; (5) vaccine characteristics and supply logistics; (6) programme planning; (7) programme monitoring and evaluation; (8) sustainable and integrated healthcare provision; (9) safety surveillance and reporting; (10) disease burden and characteristics; (11) vaccination equity and (12) human resources and training of professionals. CONCLUSIONS: This information has the potential to form the basis of a globally applicable evidence-based vaccine readiness assessment tool that can inform policy and immunisation programme decision-makers.

Opioid vaccine clinical testing: lessons learned.

PURPOSE OF REVIEW: Opioid use disorder (OUD) presents a serious public health concern, with dramatic increases in opioid-overdose mortality in recent years and a small percentage of those with OUD accessing or remaining engaged with available treatments. Efforts are currently underway to identify vaccines targeting opioids, which could provide a novel and complimentary approach. The current review provides an overview of existing literature, practical considerations for designing and conducting clinical trials with vaccines for opioids, and future directions. RECENT FINDINGS: This review covers the following themes: clinical trial design and selection of endpoints, timepoint selection, practical considerations and lessons learned from the first (ongoing) trial of a vaccine targeting opioids, and future directions. SUMMARY: Efforts to develop and test vaccines targeting OUD are based on a foundation of preclinical work and close collaboration between preclinical and clinical researchers. Efforts to learn from shortcomings of prior clinical trials of vaccines for other substances are essential in designing and testing effective vaccines for OUD. Design and implementation of clinical trials for a vaccine for OUD requires careful balance of participant safety and strategies for retention and efforts to gather viable data to inform future work.

Global and regional burden of vaccine-associated facial paralysis, 1967-2023: Findings from the WHO international pharmacovigilance database.

The scarce and conflicting data on vaccine-associated facial paralysis limit our understanding of vaccine safety on a global scale. Therefore, this study aims to evaluate the global burden of vaccine-associated facial paralysis and to identify the extent of its association with individual vaccines, thereby contributing to the development of a more effective vaccination program. We used data on vaccine-associated facial paralysis from 1967 to 2023 (total reports, n = 131 255 418 418) from the World Health Organization International Pharmacovigilance Database. Global reporting counts, reported odds ratios (ROR), and information components (ICs) were computed to elucidate the association between the 16 vaccines and the occurrence of vaccine-associated facial paralysis across 156 countries. We identified 26 197 reports (men, n = 10 507 [40.11%]) of vaccine-associated facial paralysis from 49 537 reports of all-cause facial paralysis. Vaccine-associated facial paralysis has been consistently reported; however, a pronounced increase in reported incidence has emerged after the onset of the coronavirus disease 2019 (COVID-19) pandemic, which is attributable to the COVID-19 mRNA vaccine. Most vaccines were associated with facial paralysis, with differing levels of association, except for tuberculosis vaccines. COVID-19 mRNA vaccines had the highest association with facial paralysis reports (ROR, 28.31 [95% confidence interval, 27.60-29.03]; IC, 3.37 [IC0.25, 3.35]), followed by encephalitis, influenza, hepatitis A, papillomavirus, hepatitis B, typhoid, varicella-zoster, meningococcal, Ad-5 vectored COVID-19, measles, mumps and rubella, diphtheria, tetanus toxoids, pertussis, polio, and Hemophilus influenza type b, pneumococcal, rotavirus diarrhea, and inactivated whole-virus COVID-19 vaccines. Concerning age- and sex-specific risks, vaccine-associated facial paralysis was more strongly associated with older age groups and males. The serious adverse outcome and death rate of vaccine-associated facial paralysis were extremely low (0.07% and 0.00%, respectively). An increase in vaccine-induced facial paralysis, primarily owing to COVID-19 mRNA vaccines, was observed with most vaccines, except tuberculosis vaccines. Given the higher association observed in the older and male groups with vaccine-associated facial paralysis, close monitoring of these demographics when administering vaccines that are significantly associated with adverse reactions is crucial.