BACKGROUND: For psoriatic patients who need to receive nonlive or live vaccines, evidence-based recommendations are needed regarding whether to pause or continue systemic therapies for psoriasis and/or psoriatic arthritis.
OBJECTIVE: To evaluate literature regarding vaccine efficacy and safety and to generate consensus-based recommendations for adults receiving systemic therapies for psoriasis and/or psoriatic arthritis receiving nonlive or live vaccines.
METHODS: Using a modified Delphi process, 22 consensus statements were developed by the National Psoriasis Foundation Medical Board and COVID-19 Task Force, and infectious disease experts.
RESULTS: Key recommendations include continuing most oral and biologic therapies without modification for patients receiving nonlive vaccines; consider interruption of methotrexate for nonlive vaccines. For patients receiving live vaccines, discontinue most oral and biologic medications before and after administration of live vaccine. Specific recommendations include discontinuing most biologic therapies, except for abatacept, for 2-3 half-lives before live vaccine administration and deferring next dose 2-4 weeks after live vaccination.
CONCLUSIONS: Studies regarding infection rates after vaccination are lacking.
CONCLUSIONS: Interruption of antipsoriatic oral and biologic therapies is generally not necessary for patients receiving nonlive vaccines. Temporary interruption of oral and biologic therapies before and after administration of live vaccines is recommended in most cases.

This is a revision of the online November 2021 Brighton thrombosis with thrombocytopenia syndrome (TTS) case definition and a new Brighton Collaboration case definition for vaccine-induced immune thrombocytopenia and thrombosis (VITT). These case definitions are intended for use in clinical trials and post-licensure pharmacovigilance activities to facilitate safety data comparability across multiple settings. They are not intended to guide clinical management. The case definitions were developed by a group of subject matter and Brighton Collaboration process experts as part of the Coalition for Epidemic Preparedness Innovations (CEPI)-funded Safety Platform for Evaluation of vACcines (SPEAC). The case definitions, each with defined levels of diagnostic certainty, are based on relevant published evidence and expert consensus and are accompanied by specific guidelines for TTS and VITT data collection and analysis. The document underwent peer review by a reference group of vaccine safety stakeholders and haematology experts to ensure case definition useability, applicability and scientific integrity.

Vaccinations are an essential element of public health programs around the world, which have a major impact on morbidity, mortality, and costs of the health care system. In recent years, with a better understanding of the effectiveness and safety of vaccinations, many recommendations have been developed for administering vaccines to adults. Countless physiological changes occur during pregnancy, including those affecting the immune system. Pregnant women are at increased risk of developing infections and resulting complications. According to research, vaccines are immunogenic and safe for pregnant women. Pregnancy is not an absolute contraindication to vaccination. After administration of vaccines to pregnant women, the concentration of antibodies increases, which can be transferred to the child in the second and third trimesters of pregnancy and provide protection in the first months of life. The Advisory Committee on Immunization Practices (ACIP), guidelines of the Centers for Disease Control and Prevention (CDC), and the American College of Obstetrics and Gynecology (ACOG) unanimously recommend vaccination of pregnant women if a safe vaccine is available and there is a risk of exposure of the woman to a disease that threatens herself or her developing baby. In everyday clinical practice, medical professionals should provide their patients with the necessary information on vaccinations, which may contribute to greater awareness and implementation of vaccinations. This article aims to review current global recommendations for the vaccination of pregnant and breastfeeding women, including against the Omicron variants of SARS-CoV-2.

We examine the relationships between the perception of the scientific consensus regarding vaccines, and vaccine attitudes and intentions (N total = 2,362) in the context of COVID-19 disease. Based on the correlational evidence found (Study 1), perceived scientific consensus and vaccine attitudes are closely related. This association was stronger among people who trust (vs. distrust) scientists; however, political ideology did not moderate these effects. The experimental evidence (Studies 2-3) indicates that consensus messaging influences the perception of consensus; nonetheless, the effects on vaccine attitudes or intentions were non-significant. Furthermore, message aiming at reducing psychological reactance was similarly ineffective in changing attitudes as traditional consensus message.

The number of people with immunosuppression is increasing considerably due to their greater survival and the use of new immunosuppressive treatments for various chronic diseases. This is a heterogeneous group of patients in whom vaccination as a preventive measure is one of the basic pillars of their wellbeing, given their increased risk of contracting infections. This consensus, developed jointly by the Sociedad Española de Infectología Pediátrica (Spanish Society of Pediatric Infectious Diseases) and the Advisory Committee on Vaccines of the Asociación Española de Pediatría (Spanish Association of Paediatrics), provides guidelines for the development of a personalised vaccination schedule for patients in special situations, including general recommendations and specific recommendations for vaccination of bone marrow and solid organ transplant recipients, children with inborn errors of immunity, oncologic patients, patients with chronic or systemic diseases and immunosuppressed travellers.

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The UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) is reviewing World Health Organization (WHO) manuals, guidelines and recommendations for vaccines and biotherapeutics to identify the extent to which animal-based testing methods are described. The aim is to recommend where updates to these documents can lead to an increased and more harmonised adoption of 3Rs principles (i.e. Replacement, Reduction and Refinement of animal tests) in the quality control and batch release testing requirements for vaccines and biotherapeutics. Improved adoption of 3Rs principles and non-animal testing strategies will help to reduce the delays and costs associated with product release testing. Developing recommendations that are widely applicable by both the manufacturers and national regulatory authorities for vaccines and biological therapeutics globally requires a detailed understanding of how different organisations view the opportunities and barriers to better integration of the 3Rs. To facilitate this, we developed and distributed a survey aimed at individuals who work for national regulatory authorities (NRAs) and/or national control laboratories (NCLs). In this paper, we present the key findings from this survey and how these will help inform the recommendations for wider integration of 3Rs approaches by WHO in their guidance documents applicable to the quality control and batch release testing of vaccines and biotherapeutics.

Nipah virus (NiV), a bat-borne paramyxovirus, results in neurological and respiratory diseases with high mortality in humans and animals. Developing vaccines is crucial for fighting these diseases. Previously, only a few studies focused on the fusion (F) protein alone as the immunogen. Numerous NiV strains have been identified, including 2 representative strains from Malaysia (NiV-M) and Bangladesh (NiV-B), which differ significantly from each other. In this study, an F protein sequence with the potential to prevent different NiV strain infections was designed by bioinformatics analysis after an in-depth study of NiV sequences in GenBank. Then, a chimpanzee adenoviral vector vaccine and a DNA vaccine were developed. High levels of immune responses were detected after AdC68-F, pVAX1-F, and a prime-boost strategy (pVAX1-F/AdC68-F) in mice. After high titers of humoral responses were induced, the hamsters were challenged by the lethal NiV-M and NiV-B strains separately. The vaccinated hamsters did not show any clinical signs and survived 21 days after infection with either strain of NiV, and no virus was detected in different tissues. These results indicate that the vaccines provided complete protection against representative strains of NiV infection and have the potential to be developed as a broad-spectrum vaccine for human use.

Since publication of the last consensus statement on leptospirosis in dogs, there has been revision of leptospiral taxonomy and advancements in typing methods, widespread use of new diagnostic tests and vaccines, and improved understanding of the epidemiology and pathophysiology of the disease. Leptospirosis continues to be prevalent in dogs, including in small breed dogs from urban areas, puppies as young as 11 weeks of age, geriatric dogs, dogs in rural areas, and dogs that have been inadequately vaccinated for leptospirosis (including dogs vaccinated with 2-serovar Leptospira vaccines in some regions). In 2021, the American College of Veterinary Internal Medicine (ACVIM) Board of Regents voted to approve the topic for a revised Consensus Statement. After identification of core panelists, a multidisciplinary group of 6 experts from the fields of veterinary medicine, human medicine, and public health was assembled to vote on the recommendations using the Delphi method. A draft was presented at the 2023 ACVIM Forum, and a written draft posted on the ACVIM website for comment by the membership before submission to the editors of the Journal of Veterinary Internal Medicine. This revised document provides guidance for veterinary practitioners on disease in dogs as well as cats. The level of agreement among the 12 voting members (including core panelists) is provided in association with each recommendation. A denominator lower than 12 reflects abstention of ≥1 panelists either because they considered the recommendation to be outside their scope of expertise or because there was a perceived conflict of interest.

BACKGROUND: Breaches in the cooling chain with exposure of vaccines to temperatures outside the target range of +2°C to +8°C may reduce their efficacy and impair immune responses. Following the Appraisal of Guidelines for Research and Evaluation (AGREE II) approach, this review assesses the quality and content of international clinical practice guidelines on vaccine management. The results were used to derive recommendations for the vaccine management in ambulatory care in Germany.
METHODS: Based on a systematic search and screening process with predefined criteria, the selected guidelines were rated by three reviewers using the AGREE II domains: scope and purpose, stake-holder involvement, rigor of development, clarity of presentation, applicability, and editorial independence. The content of the guidelines was retrieved and summarized according to five predefined categories: cold chain, responsibilities, equipment, storage, and monitoring. The review was registered in PROSPERO (CRD42021270524).
RESULTS: A total of nine clinical practice guidelines were selected for evaluation. The sum score of the documents varied between 17% to 89% of the maximum possible score. All guidelines included recommendations in the five content categories but differed in detail. The key recommendations were: a) continuous cold chain required; b)≥2 trained, responsible staff members; c) storage in original wrappings; d) appropriate, preferably purpose-built refrigerator with two-point thermometer or data logger; e) routinely implemented monitoring processes including daily temperature recording. A public monitoring system was recommended in some guidelines.
CONCLUSIONS: Our systematic review identified key information for vaccine storage and management to support the future development of German recommendations for vaccine storage.
UNASSIGNED: Unterbrechungen der Impfstoffkühlkette mit Temperaturen außerhalb des Zielbereichs von+2°C bis+8°C können die Wirksamkeit von Impfstoffen verringern und die Immunantwort beeinträchtigen. Die Einhaltung von Standards zum Impfstoffmanagement ist daher essentiell, doch sind für Deutschland bisher keine Leitlinien dazu formuliert. Dieser Review vergleicht die Qualität und die Inhalte internationaler Leitlinien und Empfehlungen zum Impfstoffmanagement mit Hilfe des AGREE II Instruments (Appraisal of Guidelines for Research and Evaluation). Aus den Ergebnissen werden Empfehlungen für das Impfstoffmanagement in der ambulanten Versorgung in Deutschland abgeleitet.
METHODS: Ausgehend von einer systematischen Recherche wurden internationale Leitlinien und Empfehlungen zum Impfstoffmanagement durch drei Reviewer anhand der AGREE II-Domänen bewertet. Die Domänen waren: Geltungsbereich und Zweck, Beteiligung von Interessengruppen, Genauigkeit der Leitlinienentwicklung, Klarheit der Gestaltung, Anwendbarkeit und Redaktionelle Unabhängigkeit. Die inhaltlichen Empfehlungen der Leitlinien wurden nach den fünf Kernthemen Kühlkette, Ausrüstung, Personal und Personalqualifikation, Lagerung und Monitoring analysiert. Das Studiendesign wurde in PROSPERO (CRD42021270524) registriert.
UNASSIGNED: Insgesamt wurden neun Leitlinien und Empfehlungen bewertet. Die Gesamtpunktzahl der einzelnen Publikationen variierte zwischen 17% und 89% der maximal möglichen Punktzahl. Alle Leitlinien enthielten Empfehlungen zu den fünf Kernthemen, unterschieden sich jedoch in der Detailtiefe. Die wichtigsten Empfehlungen lauteten: a) durchgehende Kühlkette erforderlich; b)≥2 geschulte Verantwortliche pro Einrichtung; c) Lagerung in der Originalverpackung; d) geeigneter Kühlschrank, vorzugsweise Spezialkühlschrank, mit Min-Max-Thermometer oder Datenlogger; e) routinemäßiges Monitoring des Impfkühlschranks mit täglicher Temperaturaufzeichnung. Ein öffentliches Überwachungssystem wird in einigen Leitlinien empfohlen.
UNASSIGNED: Unsere systematische Übersichtsarbeit identifizierte Schlüsselinformationen für die Lagerung und das Management von Impfstoffen, um die zukünftige Entwicklung deutscher Empfehlungen zur Impfstofflagerung anzuregen und zu unterstützen.