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Background: With the emergence of SARS-CoV-2, influenza surveillance systems in Spain were transformed into a new syndromic sentinel surveillance system. The Acute Respiratory Infection Surveillance System (SiVIRA in Spanish) is based on a sentinel network for acute respiratory infection (ARI) surveillance in primary care and a network of sentinel hospitals for severe ARI (SARI) surveillance in hospitals. Methods: Using a test-negative design and data from SARI admissions notified to SiVIRA between January 1 and October 3, 2021, we estimated COVID-19 vaccine effectiveness (VE) against hospitalization, by age group, vaccine type, time since vaccination, and SARS-CoV-2 variant. Results: VE was 89% (95% CI: 83-93) against COVID-19 hospitalization overall in persons aged 20 years and older. VE was higher for mRNA vaccines, and lower for those aged 80 years and older, with a decrease in protection beyond 3 months of completing vaccination, and a further decrease after 5 months. We found no differences between periods with circulation of Alpha or Delta SARS-CoV-2 variants, although variant-specific VE was slightly higher against Alpha. Conclusions: The SiVIRA sentinel hospital surveillance network in Spain was able to describe clinical and epidemiological characteristics of SARI hospitalizations and provide estimates of COVID-19 VE in the population under surveillance. Our estimates add to evidence of high effectiveness of mRNA vaccines against severe COVID-19 and waning of protection with time since vaccination in those aged 80 or older. No substantial differences were observed between SARS-CoV-2 variants (Alpha vs. Delta). The data of the study was originally collectedas part of the following projects run by the European Centre for Disease Prevention and Control:“Establishing Severe Acute Respiratory Infections (SARI) surveillance and performing hospital-based COVID-19 transmission studies”, “Developing an infrastructure and performing vaccine effectiveness studies for COVID-19 vaccines in the EU/EEA”, and the “Vaccine Effectiveness, Burden and Impact Studies(VEBIS) of COVID-19 and Influenza". Sí

Background Single-dose vaccination was widely recommended in the pre-Omicron era for persons with previous SARS-CoV-2 infection. The effectiveness of a second vaccine dose in this group in the Omicron era is unknown. Methods We linked nationwide population registries in Spain to identify community-dwelling individuals aged 18–64, with a positive SARS-CoV-2 test before single-dose mRNA vaccination (mRNA-1273 or BNT162b2). Every day between 3 January and 6 February 2022 we matched 1:1 individuals receiving a second mRNA vaccine dose and controls on sex, age, province, first dose type and time, month of primary infection, and number of previous tests. We then estimated Kaplan–Meier risks of confirmed SARS-CoV-2 reinfection. We performed a similar analysis in a Delta-dominant period, between 19 July and 30 November 2021. Results In the Omicron period, estimated effectiveness (95% CI) of a second dose was 62.2% (58.2–66.4%) 7–34 days after administration, similar across groups defined by age, sex, type of first vaccine, and time since the first dose. Estimated effectiveness was 65.4% (61.1–69.9%) for mRNA-1273 and 52.0% (41.8–63.1%) for BNT162b2. Estimated effectiveness was 78.5% (67.4–89.9%), 66.1% (54.9–77.5%), and 60.2% (55.5–64.8%) when primary infection had occurred in the Delta, Alpha, and pre-Alpha periods, respectively. In the Delta period, the estimated effectiveness of a second dose was 8.8% (−55.3% to 81.1%). Conclusions Our results suggest that, over 1 month after administration, a second dose of mRNA vaccine increases protection against SARS-CoV-2 reinfection with the Omicron variant among individuals with single-dose vaccination and previously infected with another variant.

We conducted a registries-based cohort study of long-term care facility residents >65 years of age offered vaccination against severe acute respiratory syndrome coronavirus 2 before March 10, 2021, in Spain. Risk for infection in vaccinated and nonvaccinated persons was compared with risk in the same persons in a period before the vaccination campaign, adjusted by daily-varying incidence and reproduction number. We selected 299,209 persons; 99.0% had >1 dose, 92.6% had 2 doses, and 99.8% of vaccines were Pfizer/BioNTech (BNT162b2). For vaccinated persons with no previous infection, vaccine effectiveness was 81.8% (95% CI 81.0%-82.7%), and 11.6 (95% CI 11.3-11.9) cases were prevented per 10,000 vaccinated/day. In those with previous infection, effectiveness was 56.8% (95% CI 47.1%-67.7%). In nonvaccinated residents with no previous infection, risk decreased by up to 81.4% (95% CI 73.3%-90.3%). Our results confirm vaccine effectiveness in this population and suggest indirect protection in nonvaccinated persons. Sí

[ES] En este trabajo se comparó la efectividad de la vacuna contra la COVID-19 (EV) durante agosto de 2021, en personas nacidas entre 1962 y 1971 y vacunadas durante junio, según la marca utilizada. La protección frente a infección por SARS-CoV-2 sintomática fue menor para la vacuna de Janssen (56%; IC95%: 53-59) y AstraZeneca [Vaxzevria] (68%; IC95%: 65-70), en comparación con Pfizer [Comirnaty] (78%; IC95%: 77-78), AZ/Pfizer (86%; IC95%: 80-90) y Moderna [Spikevax] (89%; IC95%: 88-90). La EV contra la hospitalización osciló entre el 86% de Janssen y el 97%-98% de las demás vacunas. [EN]In this paper we compared brand-specific COVID-19 vaccine effectiveness (VE) during August 2021 in persons born 1962-1971 and vaccinated during June. For SARS-CoV-2 symptomatic infection, protection was lower for Janssen (56%; CI95%: 53-59) or AstraZeneca [Vaxzevria] (68%; CI95%: 65-70), compared to Pfizer-BioNTech [Comirnaty] (78%; CI95%: 77-78), AstraZeneca/Pfizer (86%; CI95%: 80-90) or Moderna [Spikevax] (89%; CI95%: 88-90). VE against hospitalization was ranged 86% for Janssen to 97%-98% for other vaccines. Sí

By employing a common protocol and data from electronic health registries in Denmark, Navarre (Spain), Norway and Portugal, we estimated vaccine effectiveness (VE) against hospitalisation due to COVID-19 in individuals aged ≥ 65 years old, without previous documented infection, between October 2021 and March 2022. VE was higher in 65-79-year-olds compared with ≥ 80-year-olds and in those who received a booster compared with those who were primary vaccinated. VE remained high (ca 80%) between ≥ 12 and

I-MOVE-COVID-19 study team: Esther Kissling, Lisa Domegan, Joan O’Donnell, Josephine Murray, Virginia Sandonis Martín, Iván Martínez-Baz, Ausenda Machado, Itziar Casado, Sylvie Behillil, Amparo Larrauri, Ruby Tsang, Marit de Lange, Maximilian Riess, Jesús Castilla, Mark Hamilton, Alessandra Falchi, Francisco Pozo, Linda Dunford, Cristina Burgui, Debbie Sigerson, Thierry Blanchon, Eva María Martínez Ochoa, Jeff Connell, Joanna Ellis, Rianne van Gageldonk-Lafeber, Irina Kislaya, Angela MC Rose, Jamie Lopez Bernal, Nick Andrews, Inmaculada Casas Flecha, Janine Thoulass, Baltazar Nunes, Verónica Gomez, Rita Sa Machado, Vincent Enouf, Pedro Licinio Pinto Leite, Anna Molesworth, Adele McKenna, Janine Thoulass As the COVID-19 pandemic began in early 2020, primary care influenza sentinel surveillance networks within the Influenza - Monitoring Vaccine Effectiveness in Europe (I-MOVE) consortium rapidly adapted to COVID-19 surveillance. This study maps system adaptations and lessons learned about aligning influenza and COVID-19 surveillance following ECDC / WHO/Europe recommendations and preparing for other diseases possibly emerging in the future. Using a qualitative approach, we describe the adaptations of seven sentinel sites in five European Union countries and the United Kingdom during the first pandemic phase (March–September 2020). Adaptations to sentinel systems were substantial (2/7 sites), moderate (2/7) or minor (3/7 sites). Most adaptations encompassed patient referral and sample collection pathways, laboratory testing and data collection. Strengths included established networks of primary care providers, highly qualified testing laboratories and stakeholder commitments. One challenge was the decreasing number of samples due to altered patient pathways. Lessons learned included flexibility establishing new routines and new laboratory testing. To enable simultaneous sentinel surveillance of influenza and COVID-19, experiences of the sentinel sites and testing infrastructure should be considered. The contradicting aims of rapid case finding and contact tracing, which are needed for control during a pandemic and regular surveillance, should be carefully balanced. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101003673. info:eu-repo/semantics/publishedVersion

Introduction In July and August 2021, the SARS-CoV-2 Delta variant dominated in Europe. Aim Using a multicentre test-negative study, we measured COVID-19 vaccine effectiveness (VE) against symptomatic infection. Methods Individuals with COVID-19 or acute respiratory symptoms at primary care/community level in 10 European countries were tested for SARS-CoV-2. We measured complete primary course overall VE by vaccine brand and by time since vaccination. Results Overall VE was 74% (95% CI: 69–79), 76% (95% CI: 71–80), 63% (95% CI: 48–75) and 63% (95% CI: 16–83) among those aged 30–44, 45–59, 60–74 and ≥ 75 years, respectively. VE among those aged 30–59 years was 78% (95% CI: 75–81), 66% (95% CI: 58–73), 91% (95% CI: 87–94) and 52% (95% CI: 40–61), for Comirnaty, Vaxzevria, Spikevax and COVID-19 Vaccine Janssen, respectively. VE among people 60 years and older was 67% (95% CI: 52–77), 65% (95% CI: 48–76) and 83% (95% CI: 64–92) for Comirnaty, Vaxzevria and Spikevax, respectively. Comirnaty VE among those aged 30–59 years was 87% (95% CI: 83–89) at 14–29 days and 65% (95% CI: 56–71%) at ≥ 90 days between vaccination and onset of symptoms. Conclusions VE against symptomatic infection with the SARS-CoV-2 Delta variant varied among brands, ranging from 52% to 91%. While some waning of the vaccine effect may be present (sample size limited this analysis to only Comirnaty), protection was 65% at 90 days or more between vaccination and onset.

Background: In 2021-2022, influenza A viruses dominated in Europe. The I-MOVE primary care network conducted a multicentre test-negative study to measure influenza vaccine effectiveness (VE). Methods: Primary care practitioners collected information on patients presenting with acute respiratory infection. Cases were influenza A(H3N2) or A(H1N1)pdm09 RT-PCR positive, and controls were influenza virus negative. We calculated VE using logistic regression, adjusting for study site, age, sex, onset date, and presence of chronic conditions. Results: Between week 40 2021 and week 20 2022, we included over 11 000 patients of whom 253 and 1595 were positive for influenza A(H1N1)pdm09 and A(H3N2), respectively. Overall VE against influenza A(H1N1)pdm09 was 75% (95% CI: 43-89) and 81% (95% CI: 45-93) among those aged 15-64 years. Overall VE against influenza A(H3N2) was 29% (95% CI: 12-42) and 25% (95% CI: -41 to 61), 33% (95% CI: 14-49), and 26% (95% CI: -22 to 55) among those aged 0-14, 15-64, and over 65 years, respectively. The A(H3N2) VE among the influenza vaccination target group was 20% (95% CI: -6 to 39). All 53 sequenced A(H1N1)pdm09 viruses belonged to clade 6B.1A.5a.1. Among 410 sequenced influenza A(H3N2) viruses, all but eight belonged to clade 3C.2a1b.2a.2. Discussion: Despite antigenic mismatch between vaccine and circulating strains for influenza A(H3N2) and A(H1N1)pdm09, 2021-2022 VE estimates against circulating influenza A(H1N1)pdm09 were the highest within the I-MOVE network since the 2009 influenza pandemic. VE against A(H3N2) was lower than A(H1N1)pdm09, but at least one in five individuals vaccinated against influenza were protected against presentation to primary care with laboratory-confirmed influenza. This project has received funding from the European Centre for Disease Prevention and Control with in the framework contract ECDC/2018/029. Sí

For mRNA vaccines, protection against hospitalisation with COVID-19 prior to dominant circulation of the Delta variant was higher than during predominant Delta circulation, particularly for the 80+ age group.

Comunicación presentada en las II Jornada del Centro Nacional de Epidemiología - 2021. Se presentan resultados sobre la efectividad de la vacuna COVID-19 a partir de la información de la vigilancia centinela de Infección Respiratoria Aguda Grave. Las conclusiones del estudio son las siguientes: 1. Alta protección de las vacunas (>90%) frente a hospitalización por IRAG confirmada de COVID-19 para todas las edades, algo menor (83%) en la población de 80 y más años. 2. Las vacunas mRNA (Pfizer, Moderna) presentan la EV más alta (90%), seguidas por Janssen (79%) y AstraZeneca (73%). 3. Bajada progresiva de la EV después de cinco meses de la vacunación. 4. Alta protección frente a las variantes Alpha y Delta, aunque ligera menor EV frente a la hospitalización de IRAG con variante Delta, en comparación con Alpha.

Background: The first signal of a new infection is often severe cases presenting at hospital. Enhanced surveillance of these cases is critical to learning more about disease epidemiology and patient outcomes, but nationallevel surveillance can lack power to draw conclusions. In response to the emergence of SARS-CoV-2, the Influenza-Monitoring Vaccine Effectiveness (I-MOVE) network, founded in 2007, expanded to establish the I-MOVE-COVID-19 Consortium in February 2020. The Consortium’s surveillance objectives included using pooled data to describe clinical and epidemiological characteristics of hospitalised COVID-19 patients across Europe, in order to contribute to the knowledge base, guide patient management, and inform public health response. Methods: Eleven study sites participated in the surveillance, including 23 hospitals across six EU Member States and Albania, and hospitals nationally in England and Scotland. A standardised protocol and dataset for collection was agreed by April 2020. In England and Scotland, data were generated by linkage of routine datasets; other sites used bespoke paper or electronic questionnaires. Data were submitted, pooled and analysed quarterly. Results: Data were received regarding 84,297 COVID-19 patients hospitalised between 1 February 2020 and 31 January 2021. Three surveillance bulletins were published between September 2020 and March 2021, providing key insights into severe COVID-19 at European level. However, the unexpected, overwhelming workload at participating sites, and difficulties securing data protection and ethics permissions, delayed data submissions and presented challenges for timely analysis. Conclusions: Building on an existing network facilitated a novel European multicentre hospital surveillance system to be implemented during a pandemic; however, timeliness was nonetheless problematic. In future, processes could be streamlined e.g. by developing pre-approved template protocols with information governance and ethical approvals in place during the inter- pandemic period. The I-MOVE-COVID-19 network has received funding from the European Commission (from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 101003673). N/A

Background: The I-MOVE-COVID-19 Consortium was established to conduct surveillance of hospitalised COVID-19 cases in nine European countries, aiming to describe the clinical and epidemiological characteristics of severe COVID-19 in order to inform public health response. Methods: Data are pooled from 11 participating sites; two (England and Scotland) submitting national data, with the remainder being from a selection of hospitals. Descriptive analysis is performed on the pooled dataset overall and comparing data on patients admitted from week 5 to 28 of 2020 (“first wave”) vs those admitted later (“second wave”). Results: Data on 84,297 hospitalised patients were submitted for 01 February 2020 - 31 January 2021. Fifty-six percent of cases (46,907/84,193) were male and median age was 69 years. Where information was available, 44% (25,344 /57,769) patients were recorded as having at least one chronic condition. Ninety-five percent (7,868/8,270 and 90% (5,606/6,231) were reported with respiratory and febrile presentations respectively. Twenty-four percent (18,795/78,955) were admitted to intensive care units (ICU) and 26% (19,805/76,764) died in hospital (all sites); 12% (3,305/28,262) and 20% (5,454/27,066) respectively for all sites except England (where ICU reporting is mandated, biasing the dataset towards more severe outcomes as this site represents >50% of all cases). As a percentage of all hospital admissions, both ICU admissions and deaths decreased significantly between the first and second waves in both sexes and across all age- groups, apart from the over 75s. Conclusions: Results from this multicentre European surveillance system suggest that about one in 10 hospitalised COVID-19 patients are admitted to ICU and one in five have fatal outcomes. Fatality and ICU admission were lower in the second wave compared with the first. The I-MOVE-COVID-19 network has received funding from the European Commission (from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 101003673). N/A

I-MOVE-COVID-19 primary care study team (in addition to authors above): Nick Andrews, Jamie Lopez Bernal, Heather Whitaker, Caroline Guerrisi, Titouan Launay, Shirley Masse, Sylvie van der Werf, Vincent Enouf, John Cuddihy, Adele McKenna, Michael Joyce, Cillian de Gascun, Joanne Moran, Ana Miqueleiz, Ana Navascués, Camino Trobajo-Sanmartín, Carmen Ezpeleta, Paula López Moreno, Javier Gorricho, Eva Ardanaz, Fernando Baigorria, Aurelio Barricarte, Enrique de la Cruz, Nerea Egüés, Manuel García Cenoz, Marcela Guevara, Conchi Moreno-Iribas, Carmen Sayón, Verónica Gomez, Baltazar Nunes, Rita Roquete, Adriana Silva, Aryse Melo, Inês Costa, Nuno Verdasca, Patrícia Conde, Diogo FP Marques, Anna Molesworth, Leanne Quinn, Miranda Leyton, Selin Campbell, Janine Thoulass, Jim McMenamin, Ana Martínez Mateo, Luca Basile, Daniel Castrillejo, Carmen Quiñones Rubio, Concepción Delgado-Sanz, Jesús Oliva. The I-MOVE-COVID-19 network collates epidemiological and clinical information on patients with coronavirus disease (COVID-19), including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virological characterisation in 11 European countries [1]. One component of I-MOVE-COVID-19 is the multicentre vaccine effectiveness (VE) study at primary care/outpatient level in nine European study sites in eight countries. We measured overall and product-specific COVID-19 VE against symptomatic SARS-CoV-2 infection among those aged 65 years and older. We also measured VE by time since vaccination. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101003673. info:eu-repo/semantics/publishedVersion

Residents in long-term care facilities (LTCF) experienced a large morbidity and mortality during the COVID-19 pandemic in Spain and were prioritised for early COVID-19 vaccination. We used the screening method and population-based data sources to obtain estimates of mRNA COVID-19 vaccine effectiveness for elderly LTCF residents. The estimates were 71% (95% CI: 56–82%), 88% (95% CI: 75–95%), and 97% (95% CI: 92-99%), against SARS-CoV-2 infections (symptomatic and asymptomatic), and COVID-19 hospitalisations and deaths, respectively.

Comunicación presentada en las II Jornada del Centro Nacional de Epidemiología - 2021. Se estudia el impacto de la COVID-19 en la mortalidad en España. Los objetivos del estudio son: 1. Analizar la mortalidad por COVID-19 en España, describiendo las tres primeras olas pandémicas de COVID-19 y proporcionando estimaciones por grupo de edad y regiones españolas; y 2. Comparar el exceso de mortalidad por todas las causas de MoMo durante la pandemia de COVID-19 con las muertes confirmadas por COVID-19 notificadas al sistema nacional de vigilancia. Las conclusiones son: 1. MoMo identificó un exceso de mortalidad sin precedentes, en la primera ola pandémica de COVID-19 en España, que coincidió con la aparición de la pandemia COVID-19, 2. El sistema MoMo puede proporcionar estimaciones de exceso de mortalidad por todas las causas por edad y región geográfica, y 3. A pesar de ser un sistema inespecífico que no permite establecer causalidad directa en el análisis de exceso de mortalidad, MoMo constituye una herramienta esencial de vigilancia a tiempo real, como sistema de alerta temprana para la acción en salud pública, y para realizar estimaciones del impacto de diferentes eventos de salud en la mortalidad de la población.

Background: The analysis of the evolution of the COVID-19 epidemic can provide evidence of the impact of measures implemented to reduce its progression. Our aim was to describe the evolution of the pandemic in the different Spanish regions and to examine the effect of the non-pharmaceutical public health interventions during the first epidemic wave on these trends. Methods: Daily incidence rates of cases were calculated at national and regional level between 31th of January and 10th of May 2020. Epidemic curves, important dates of interventions and effective reproduction number (Rt) were plotted and transmissibility parameters were calculated. To summarize the geographical heterogeneity in the evolution, regional epidemic curves have been classified into homogeneous groups using a clustering procedure. Findings: The incidence rate reached 5 cases per 100,000 on March 1 and peaked at March 20. The Rt gradually decreased after the national lockdown falling below 1 on March 24. Two homogeneous groups of epidemic curves were identified among regions, mainly differentiated by the magnitude of the daily incidence rate and the evolution of the Rt in the period prior to lockdown. However, irrespectively of the previous trend, the lockdown was followed by a steep decrease in the number of cases starting 6 days after its implementation. Interpretation: Our results confirm that the restrictive national lockdown efficiently reduced the progression of the epidemic in Spain during the first wave. This effect was similar in the two regional clusters, independent of the previous dynamics of the epidemic. Funding Statement: The study was supported by Instituto de Salud Carlos III, Spain (ISCIII) grant number COV20-008 Declaration of Interests: All authors declare no competing interests.

Este documento presenta un resumen de los estudios coordinados desde el Ministerio de Sanidad para evaluar la efectividad y el impacto de la vacunación frente a COVID-19 en residentes de centros sociosanitarios de mayores en España. No