Review: N1-methyl-pseudouridine (m1Ψ): Friend or foe of cancer?

Due to the health emergency created by SARS-CoV-2, the virus that causes the COVID-19 disease, the rapid implementation of a new vaccine technology was necessary. mRNA vaccines, being one of the cutting-edge new technologies, attracted significant interest and offered a lot of hope. The potential of these vaccines in preventing admission to hospitals and serious illness in people with comorbidities has recently been called into question due to the vaccines' rapidly waning immunity. Mounting evidence indicates that these vaccines, like many others, do not generate sterilizing immunity, leaving people vulnerable to recurrent infections. Additionally, it has been discovered that the mRNA vaccines inhibit essential immunological pathways, thus impairing early interferon signaling. Within the framework of COVID-19 vaccination, this inhibition ensures an appropriate spike protein synthesis and a reduced immune activation. Evidence is provided that adding 100 % of N1-methyl-pseudouridine (m1Ψ) to the mRNA vaccine in a melanoma model stimulated cancer growth and metastasis, while non-modified mRNA vaccines induced opposite results, thus suggesting that COVID-19 mRNA vaccines could aid cancer development. Based on this compelling evidence, we suggest that future clinical trials for cancers or infectious diseases should not use mRNA vaccines with a 100 % m1Ψ modification, but rather ones with the lower percentage of m1Ψ modification to avoid immune suppression.

Searching for common ground.

The conserved coronavirus fusion peptide is a target of broadly neutralizing antibodies.

Monoclonal Antibodies to S and N SARS-CoV-2 Proteins as Probes to Assess Structural and Antigenic Properties of Coronaviruses.

Antibodies targeting the spike (S) and nucleocapsid (N) proteins of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are essential tools. In addition to important roles in the treatment and diagnosis of infection, the availability of high-quality specific antibodies for the S and N proteins is essential to facilitate basic research of virus replication and in the characterization of mutations responsible for variants of concern. We have developed panels of mouse and rabbit monoclonal antibodies (mAbs) to the SARS-CoV-2 spike receptor-binding domain (S-RBD) and N protein for functional and antigenic analyses. The mAbs to the S-RBD were tested for neutralization of native SARS-CoV-2, with several exhibiting neutralizing activity. The panels of mAbs to the N protein were assessed for cross-reactivity with the SARS-CoV and Middle East respiratory syndrome (MERS)-CoV N proteins and could be subdivided into sets that showed unique specificity for SARS-CoV-2 N protein, cross-reactivity between SARS-CoV-2 and SARS-CoV N proteins only, or cross-reactivity to all three coronavirus N proteins tested. Partial mapping of N-reactive mAbs were conducted using truncated fragments of the SARS-CoV-2 N protein and revealed near complete coverage of the N protein. Collectively, these sets of mouse and rabbit monoclonal antibodies can be used to examine structure/function studies for N proteins and to define the surface location of virus neutralizing epitopes on the RBD of the S protein.

High Levels of Common Cold Coronavirus Antibodies in Convalescent Plasma Are Associated With Improved Survival in COVID-19 Patients.

Background: COVID-19 Convalescent plasma (CCP) is safe and effective, particularly if given at an early stage of the disease. Our study aimed to identify an association between survival and specific antibodies found in CCP. Patients and Methods: Patients ≥18 years of age who were hospitalized with moderate to severe COVID-19 infection and received CCP at the MD Anderson Cancer Center between 4/30/2020 and 8/20/2020 were included in the study. We quantified the levels of anti-SARS-CoV-2 antibodies, as well as antibodies against antigens of other coronavirus strains, in the CCP units and compared antibody levels with patient outcomes. For each antibody, a Bayesian exponential survival time regression model including prognostic variables was fit, and the posterior probability of a beneficial effect (PBE) of higher antibody level on survival time was computed. Results: CCP was administered to 44 cancer patients. The median age was 60 years (range 37-84) and 19 (43%) were female. Twelve patients (27%) died of COVID-19-related complications. Higher levels of two non-SARS-CoV-2-specific antibodies, anti-HCoV-OC43 spike IgG and anti-HCoV-HKU1 spike IgG, had PBE = 1.00, and 4 SARS-CoV-2-specific antibodies had PBEs between 0.90 and 0.95. Other factors associated with better survival were shorter time to CCP administration, younger age, and female sex. Conclusions: Common cold coronavirus spike IgG antibodies anti-HCoV-OC43 and anti-HCoV-HKU1 may target a common domain for SARS-CoV-2 and other coronaviruses. They provide a promising therapeutic target for monoclonal antibody production.

Consideraciones sobre los eventos trombóticos posteriores a la administración de la vacuna de AstraZeneca contra COVID-19 en Europa / Considerations for Thrombotic Events Following AstraZeneca COVID-19 Vaccine Administration in Europe

En las campañas de vacunación, como en la actual situación de COVID-19, es habitual que los países señalen posibles efectos adversos después de la vacunación. Esto no significa necesariamente que los eventos estén relacionados con la vacunación en sí, pero es necesario investigarlos. También muestra que el sistema de vigilancia funciona y que existen controles efectivos. La Organización Mundial de la Salud (OMS) está en contacto regular con la Agencia Europea de Medicamentos (EMA) y otras autoridades reguladoras del mundo para obtener la información más reciente sobre la seguridad de todas las vacunas para COVID-19.

Guía para elaborar una estrategia de comunicación de riesgos sobre las vacunas contra la COVID-19 / Guía para elaborar una estrategia de comunicación de riesgos sobre las vacunas contra la COVID-19 / Guide for the preparation of a risk communication strategy for COVID-19 vaccines: A Resource for the countries of the Americas

Todos os países do mundo formularam planos de resposta para enfrentar a pandemia da COVID-19. No entanto, os desafios impostos pela doença os obrigam a aprender e adaptar-se constantemente. Cada vez mais é necessário reforçar o componente de comunicação de riscos como uma ferramenta essencial para transmitir à população, da devida forma, todas as informações sobre o processo de imunização, desde os testes clínicos e a produção de novas vacinas, até a adoção, distribuição e priorização dos grupos aos quais serão administradas uma ou mais vacinas ­ dependendo da definição e disponibilidade de cada país ­, bem como sobre o acesso universal às vacinas, após os grupos prioritários terem sido imunizados. A Organização Pan-Americana da Saúde, em seu esforço constante e permanente para apoiar os países das Américas, apresenta este documento para facilitar a formulação de uma estratégia de comunicação de riscos e participação comunitária (CRPC) para a vacinação contra o SARS-CoV-2. O intuito é contribuir para o fortalecimento das capacidades de comunicação e planejamento dos ministérios e secretarias de saúde, bem como de outros órgãos responsáveis pela comunicação na área das novas vacinas contra a COVID-19 nas Américas.

Todos los países del mundo han desarrollado planes de respuesta para enfrentar la pandemia de COVID-19; sin embargo, los desafíos que presenta la enfermedad los obliga a un aprendizaje y a una adaptación constantes. Cada vez es más necesario reforzar el componente de comunicación de riesgos como herramienta esencial para transmitir de forma adecuada a la población toda la información sobre el proceso de inmunización, desde los ensayos clínicos y la producción de nuevas vacunas, hasta la introducción, distribución y priorización de grupos a los que hay que administrar una o varias vacunas ­según la definición y la disponibilidad de cada país­ así como el acceso universal a ellas, una vez inmunizados los grupos prioritarios. La OPS, dentro de su empeño constante por apoyar a los países de las Américas, publica el presente documento con ánimo de facilitar la elaboración de una estrategia de comunicación de riesgos y participación comunitaria para la vacunación contra la COVID-19. Su finalidad es contribuir a fortalecer las capacidades y la planificación de la comunicación de los ministerios o secretarías de salud, así como de otros organismos encargados de comunicar en el área de las nuevas vacunas contra la COVID-19 en las Américas.

All countries around the world have developed response plans to tackle the COVID-19 pandemic. However, the challenges presented by the disease require constant learning and adaptation. It is increasingly necessary to strengthen the risk communication component as an essential tool for providing the population with all of the necessary information about the immunization process. This ranges from clinical trials and the production of new vaccines to the introduction, distribution, and prioritization of groups that need one or more vaccines­according to each country's definitions and vaccine availability. It also includes universal access to vaccines, once the priority groups have been immunized. PAHO, in its constant, ongoing effort to support the countries of the Americas, is making this document available to facilitate the preparation of a risk communication and community engagement strategy for vaccination against COVID-19. Its goal is to help to strengthen the communication and planning capacities of the ministries or secretariats of health and other agencies in charge of communicating about new COVID-19 vaccines in the Americas.

Introdução da vacina contra a COVID-19: orientações para determinar os grupos prioritários e elaborar o microplanejamento. Versão 1, 18 de janeiro de 2021 / Introducción de la vacuna contra la COVID-19: orientaciones para determinar los grupos prioritarios y elaborar la microplanificación. 18 de enero del 2021 / Introducing COVID-19 vaccination: Guidance for determining priority groups and microplanning. Version 1, 18 January 2021 / Introduction du vaccin contre la COVID-19: orientations pour l'identification des groupes prioritaires et la micro-planification. Version 1, 18 janvier 2021

Há quase um ano desde o início da pandemia de COVID-19, e os cientistas de todo o mundo avançaram rapidamente no desenvolvimento de vacinas seguras e eficazes que ajudarão a reduzir doenças, hospitalizações e mortes associadas à COVID-19. Espera-se que essas vacinas contribuam consideravelmente para a proteção e a promoção equitativas do bem-estar humano e que possibilitem o retorno progressivo às atividades sociais, econômicas, profissionais e familiares. O objetivo deste documento é apoiar os países da Região das Américas no planejamento dos componentes operacionais do programa de imunizações em preparação para a vacina contra a COVID-19. Para tanto, seguem-se os princípios e valores recomendados pelo SAGE e pelo GTA bem como as recomendações técnicas da OPAS e da OMS. Essas recomendações destinam-se ao planejamento da introdução das vacinas contra a COVID-19 no nível operacional, seguindo as recomendações do roteiro do SAGE e da priorização dos grupos populacionais estabelecida pelo país. As recomendações são preliminares e serão atualizadas à medida que novas evidências forem disponibilizadas.

A casi un año del inicio de la pandemia de COVID-19, científicos de todo el mundo han avanzado rápidamente en el desarrollo de vacunas seguras y eficaces que contribuirán a reducir las enfermedades, las hospitalizaciones y las muertes asociadas a la COVID-19. Se espera que dichas vacunas ayuden significativamente a proteger y promocionar de manera equitativa el bienestar humano, y que permitan retomar de forma progresiva las actividades sociales, económicas, laborales y familiares. El propósito de este documento es apoyar a los países de la Región de las Américas a planificar los componentes operacionales del programa de inmunizaciones en preparación para la introducción de la vacuna contra la COVID-19. Para ello se siguen los principios y los valores recomendados por el Grupo de Expertos de la Organización Mundial de la Salud (OMS) en Asesoramiento Estratégico sobre Inmunización y el Grupo Técnico Asesor sobre enfermedades prevenibles por vacunación de la Organización Panamericana de la Salud (OPS), así como las recomendaciones técnicas de la OPS y la OMS. El documento contiene recomendaciones relativas a la microplanificación de la introducción de las vacunas y a la priorización de los grupos poblacionales. Las recomendaciones son preliminares y se actualizarán a medida que se disponga de nueva evidencia.

Almost a year into the COVID-19 pandemic, scientists throughout the world have swiftly moved to develop safe and effective vaccines that will help reduce illness, hospitalizations, and deaths associated with COVID-19. These vaccines are expected to make a significant contribution to equitable protection and promotion of human well-being and a gradual return to social, economic, work, and family life. This manual is designed to assist the countries of the Region of the Americas in planning the operational components of the immunization program to ready them for the COVID-19 vaccine. To accomplish this, it follows the principles and values recommended by SAGE and the TAG, as well as the technical recommendations of PAHO and WHO. The aim of these recommendations is to plan for the introduction of COVID-19 vaccines at the operational level and country prioritization of population groups. The recommendations are preliminary and will be updated as new evidence becomes available.

Près d'un an après le début de la pandémie de COVID-19, les scientifiques du monde entier ont réalisé des avancées rapides dans la mise au point de vaccins sûrs et efficaces qui contribueront à réduire les maladies, les hospitalisations et les décès associés à la COVID­19. Ces vaccins devraient contribuer de manière significative à la protection et à la promotion équitables du bien-être humain, et permettre un retour progressif aux activités sociales, économiques, professionnelles et familiales. Le présent document a pour objet d'aider les pays de la Région des Amériques à planifier les composantes opérationnelles du programme de vaccination en vue des préparatifs concernant le vaccin contre la COVID-19. Il suit les principes et les valeurs recommandés par le SAGE et le GCT, ainsi que les recommandations techniques de l'OPS et de l'OMS. Ces recommandations visent à planifier l'introduction des vaccins contre la COVID-19 au niveau opérationnel et la détermination des groupes de population à vacciner en priorité. Les recommandations sont préliminaires et seront mises à jour à mesure que de nouveaux éléments probants seront disponibles.

Guía para elaborar un plan nacional de despliegue y vacunación para las vacunas contra la COVID-19 / Guidance on developing a national deployment and vaccination plan for COVID-19 vaccines

El propósito de esta guía es brindar orientación sobre 1) la elaboración y actualización del plan nacional de despliegue y vacunación para las vacunas contra la COVID­19; 2) el diseño de estrategias para el despliegue, la imeplementación y el seguimiento; y 3) la armonización del plan y el financiamiento con los demás planes nacionales de recuperación, respuesta y apoyo frente a la COVID-19. Está dirigida a las autoridades nacionales responsables de gestionar el despliegue, la implementación y el seguimiento de las vacunas contra la COVID­19, así como a los asociados encargados de prestar el apoyo necesario.

Actualización epidemiológica: variantes de SARS-CoV-2 en las Américas - 24 de marzo de 2021 / Epidemiological update: SARS-CoV-2 variants in the Americas - March 24, 2021

A la fecha, 141 los países/territorios han detectado casos de infección por alguna de las tres variantes de preocupación (VOC) reconocidas actualmente por la Organización Mundial de la Salud (OMS). De ese total, 32 países/territorios corresponden a la Región de las Américas.

Orientaciones para la implementación del Sistema Regional de Vigilancia de ESAVI y AESI en el contexto de la COVID-19 / Guidance for Implementing the Regional COVID-19 Vaccine AEFI/AESI Surveillance System

El propósito de estas orientaciones es apoyar el desarrollo de un sistema regional de vigilancia de ESAVI y AESI sensible, oportuno, estandarizado, confiable e integrado, con la participación de todos los actores involucrados en la vacunación segura, con vistas a mantener la confianza en la vacunación y la aceptación de la inmunización en las Américas. El sistema contribuirá a la detección temprana y a la clasificación adecuada de los ESAVI graves y de las señales de riesgo, para generar una respuesta rápida y apropiada a nivel nacional y regional.

The purpose of tthis guidance document is to develop a sensitive, timely, standardized, reliable, and integrated regional AEFI surveillance system with the participation of all actors involved in safe vaccination to maintain trust in vaccination and acceptance of immunization in the Americas. Contribute to the early detection and correct classification of serious AEFIs and risk markers to generate a rapid and appropriate national and regional response.

Preguntas frecuentes sobre las vacunas experimentales contra la COVID-19 y los mecanismos de acceso - versión 3, 6 de enero del 2021 / Frequently asked questions (FAQs) about COVID-19 Candidate Vaccines and Access Mechanisms - version 3, 6 January 2021 / Perguntas frequentes sobre as vacinas candidatas contra a COVID-19 e os mecanismos de acesso a elas - versão 3, 6 de janeiro de 2021

Los interrogantes sobre la eficacia y la seguridad de las vacunas se encuentran entre las preguntas relacionadas con la vacunación que más a menudo se plantean. Esta tercera edición de Preguntas frecuentes sobre las vacunas experimentales contra la COVID-19 y los mecanismos de acceso ofrece respuestas a estas y otras preguntas. Asimismo, el documento explica las diferentes fases por las que pasa una vacuna antes de obtener aprobación y facilita información sobre las vacunas experimentales y la vacunación contra la COVID-19.

Will COVID-19 vaccines be safe? Will all the COVID-19 candidate vaccines be successful? What are the different phases a vaccine must go through to be approved? This document provides responses to the most frequently asked questions about candidate vaccines and access to COVID-19 vaccination.

Existe uma vacina contra a COVID-19? Todas as vacinas candidatas contra a COVID-19 serão bem-sucedidas? Quais são as diferentes fases que uma vacina deve passar para ser aprovada? Este documento responde às perguntas mais frequentes sbre as vacinas experimentais e os mecanismos de acesso disponíveis em cada país.