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      Insights for COVID-19 in 2023 Translated title: Perspectivas de COVID-19 para 2023

      review-article
      1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 ,
      Revista Española de Quimioterapia
      Sociedad Española de Quimioterapia
      COVID-19, SARS-CoV2, Vaccination, bivalent vaccines, nasal and oral vaccines, investigational drugs against SARS-CoV2, use of masks, Long-term COVID, COVID-19, SARS-CoV2, Vacunación, vacunas bivalentes, vacunas nasales y orales, fármacos en investigación frente a SARS-CoV2, uso de mascarillas, COVID-largo

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          Abstract

          Predictions for a near end of the pandemic by the World Health Organization should be interpreted with caution. Current evidence indicates that the efficacy of a fourth dose of classical mRNA vaccines (BT162b2 or mRNA-1273) is low and short-lived in preventing SARS-CoV-2 infection in its predominant variant (Omicron). However, its efficacy is high against severe symptomatic infection, hospitalization and death. The new vaccines being introduced are bivalent and active against the Omicron variants. Potential new vaccines to be introduced in the coming year include a vaccine based on a recombinant protein that emulates the receptor binding domain of the Spike protein under development by the Spanish company Hipra, as well as vaccines for nasal or oral administration. Available information suggests that vaccines against COVID-19 can be administered in association with influenza vaccination without particular complications. New drugs against COVID-19, both anti-viral and anti-inflammatory, are under investigation, but this does not seem to be the case with monoclonal antibodies. The indication to use masks in some circumstances will be maintained next year in view of the accumulation of scientific data on their efficacy. Finally, the long COVID or Post-COVID syndrome may continue to affect a very high proportion of patients who have had the disease, requiring combined diagnostic and therapeutic resources.

          Translated abstract

          Las predicciones para un próximo fin de la pandemia de la Organización Mundial de la Salud deben interpretarse con precaución. La evidencia actual indica que la eficacia de una cuarta dosis de las vacunas clásicas ARNm (BNT162b2 o mRNA-1273) es baja y de corta duración para prevenir la infección de SARS-CoV-2 en su variante predominante (Omicron). No obstante, su eficacia es alta frente a la infección sintomática grave, hospitalización y muerte. Las nuevas vacunas que están siendo introducidas son bivalentes y activas frente a las variantes Omicron. Entre las potenciales nuevas vacunas que se introducirán en el próximo año, se encuentra una vacuna basada en una proteína recombinante que emula el dominio de unión al receptor de la proteína Spike en desarrollo por la compañía española Hipra, así como vacunas de administración nasal u oral. La información disponible apunta a que las vacunas frente al COVID-19 podrán administrarse asociadas a la vacunación antigripal sin particulares complicaciones. Se encuentran en investigación nuevos fármacos frente a COVID-19 tanto antivirales como anti-inflamatorios pero no parece ocurrir lo mismo con los anticuerpos monoclonales. La indicación de utilizar mascarillas en algunas circunstancias se mantendrá el próximo año en vista a la acumulación de datos científicos sobre su eficacia. Finalmente, el síndrome del COVID largo o Post-COVID puede que siga afectando a una proporción muy elevada de los pacientes que sufrieron la enfermedad, requiriendo recursos diagnósticos y terapéuticos combinados.

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          Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression

          Background Knowing whether COVID-19 vaccine effectiveness wanes is crucial for informing vaccine policy, such as the need for and timing of booster doses. We aimed to systematically review the evidence for the duration of protection of COVID-19 vaccines against various clinical outcomes, and to assess changes in the rates of breakthrough infection caused by the delta variant with increasing time since vaccination. Methods This study was designed as a systematic review and meta-regression. We did a systematic review of preprint and peer-reviewed published article databases from June 17, 2021, to Dec 2, 2021. Randomised controlled trials of COVID-19 vaccine efficacy and observational studies of COVID-19 vaccine effectiveness were eligible. Studies with vaccine efficacy or effectiveness estimates at discrete time intervals of people who had received full vaccination and that met predefined screening criteria underwent full-text review. We used random-effects meta-regression to estimate the average change in vaccine efficacy or effectiveness 1–6 months after full vaccination. Findings Of 13 744 studies screened, 310 underwent full-text review, and 18 studies were included (all studies were carried out before the omicron variant began to circulate widely). Risk of bias, established using the risk of bias 2 tool for randomised controlled trials or the risk of bias in non-randomised studies of interventions tool was low for three studies, moderate for eight studies, and serious for seven studies. We included 78 vaccine-specific vaccine efficacy or effectiveness evaluations (Pfizer–BioNTech-Comirnaty, n=38; Moderna-mRNA-1273, n=23; Janssen-Ad26.COV2.S, n=9; and AstraZeneca-Vaxzevria, n=8). On average, vaccine efficacy or effectiveness against SARS-CoV-2 infection decreased from 1 month to 6 months after full vaccination by 21·0 percentage points (95% CI 13·9–29·8) among people of all ages and 20·7 percentage points (10·2–36·6) among older people (as defined by each study, who were at least 50 years old). For symptomatic COVID-19 disease, vaccine efficacy or effectiveness decreased by 24·9 percentage points (95% CI 13·4–41·6) in people of all ages and 32·0 percentage points (11·0–69·0) in older people. For severe COVID-19 disease, vaccine efficacy or effectiveness decreased by 10·0 percentage points (95% CI 6·1–15·4) in people of all ages and 9·5 percentage points (5·7–14·6) in older people. Most (81%) vaccine efficacy or effectiveness estimates against severe disease remained greater than 70% over time. Interpretation COVID-19 vaccine efficacy or effectiveness against severe disease remained high, although it did decrease somewhat by 6 months after full vaccination. By contrast, vaccine efficacy or effectiveness against infection and symptomatic disease decreased approximately 20–30 percentage points by 6 months. The decrease in vaccine efficacy or effectiveness is likely caused by, at least in part, waning immunity, although an effect of bias cannot be ruled out. Evaluating vaccine efficacy or effectiveness beyond 6 months will be crucial for updating COVID-19 vaccine policy. Funding Coalition for Epidemic Preparedness Innovations.
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            An evidence review of face masks against COVID-19

            The science around the use of masks by the public to impede COVID-19 transmission is advancing rapidly. In this narrative review, we develop an analytical framework to examine mask usage, synthesizing the relevant literature to inform multiple areas: population impact, transmission characteristics, source control, wearer protection, sociological considerations, and implementation considerations. A primary route of transmission of COVID-19 is via respiratory particles, and it is known to be transmissible from presymptomatic, paucisymptomatic, and asymptomatic individuals. Reducing disease spread requires two things: limiting contacts of infected individuals via physical distancing and other measures and reducing the transmission probability per contact. The preponderance of evidence indicates that mask wearing reduces transmissibility per contact by reducing transmission of infected respiratory particles in both laboratory and clinical contexts. Public mask wearing is most effective at reducing spread of the virus when compliance is high. Given the current shortages of medical masks, we recommend the adoption of public cloth mask wearing, as an effective form of source control, in conjunction with existing hygiene, distancing, and contact tracing strategies. Because many respiratory particles become smaller due to evaporation, we recommend increasing focus on a previously overlooked aspect of mask usage: mask wearing by infectious people (“source control”) with benefits at the population level, rather than only mask wearing by susceptible people, such as health care workers, with focus on individual outcomes. We recommend that public officials and governments strongly encourage the use of widespread face masks in public, including the use of appropriate regulation.
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              Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

              Background Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age. Methods A phase 1, dose-finding study and an ongoing phase 2–3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2–3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed. Results During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2–3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3). Conclusions A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643 .)
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                Author and article information

                Journal
                Rev Esp Quimioter
                Rev Esp Quimioter
                Sociedad Española de Quimioterapia
                Revista Española de Quimioterapia
                Sociedad Española de Quimioterapia
                0214-3429
                1988-9518
                13 December 2022
                2023
                : 36
                : 2
                : 114-124
                Affiliations
                [1 ]Emergency Service. San Carlos University Clinical Hospital. Complutense University. Madrid.
                [2 ]Cardiology Service. Gregorio Marañón General University Hospital, European University. Madrid
                [3 ]Family Medicine. Infectious diseases. Madrid.
                [4 ]Infectious Diseases Service. Ramón y Cajal Hospital. University of Alcalá de Henares. Madrid.
                [5 ]Department of Public Health. Autonomous University. Madrid
                [6 ]Internal Medicine Service. Ruber International Hospital. Madrid.
                [7 ]Microbiology Service. Ramón y Cajal Hospital and Ramón y Cajal Institute for Health Research (IRYCIS). Spanish Network for Research in Infectious Pathology (REIPI). Madrid.
                [8 ]Emeritus. Pneumology Service. Gregorio Marañón General University Hospital, Complutense University. Madrid
                [9 ]General Surgery Service. San Carlos University Clinical Hospital. Complutense University. Madrid.
                [10 ]Cardiology Service. Prince of Asturias Hospital. University of Alcalá. Madrid.
                [11 ]Pediatrics and ACES Service. Gregorio Marañón General University Hospital, Complutense University. Madrid.
                [12 ]Geriatrics Service. Central Hospital of the Red-Cross. Alfonso X el Sabio University. Madrid
                [13 ]Emergency Service. San Carlos University Clinical Hospital. Complutense University. Madrid.
                [14 ]Intensive Medicine Service. Torrejón University Hospital. Francisco de Vitoria University. Madrid
                [15 ]Clinical Emeritus, Community of Madrid. Clinical Microbiology and Infectious Diseases Service of the Gregorio Marañón General University Hospital, Complutense University. CIBERES. Cyber of Respiratory Diseases. Madrid.
                Author notes
                Correspondence: Emilio Bouza Servicio de Microbiología Clínica y Enfermedades Infecciosas del Hospital General Universitario Gregorio Marañón, Universidad Complutense. CIBERES. Ciber de Enfermedades Respiratorias. Madrid E-mail: emilio.bouza@ 123456gmail.com

                All authors belong to the Scientific Committee on COVID-19 of the Madrid College of Physicians (ICOMEM).

                Article
                revespquimioter-36-114
                10.37201/req/122.2022
                10066911
                36510683
                9ca76028-7583-43e7-a017-10ee23cd4603
                © The Author 2022

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)( https://creativecommons.org/licenses/by-nc/4.0/).

                History
                : 16 November 2022
                : 30 November 2022
                Categories
                Review

                covid-19,sars-cov2,vaccination,bivalent vaccines,nasal and oral vaccines,investigational drugs against sars-cov2,use of masks,long-term covid,vacunación,vacunas bivalentes,vacunas nasales y orales,fármacos en investigación frente a sars-cov2,uso de mascarillas,covid-largo

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