Effectiveness of one and two doses of acellular pertussis vaccines against laboratory-confirmed pertussis requiring hospitalisation in infants: Results of the PERTINENT sentinel surveillance system in six EU/EEA countries, December 2015 - December 2019.

BACKGROUND: Monitoring effectiveness of pertussis vaccines is necessary to adapt vaccination strategies. PERTINENT, Pertussis in Infants European Network, is an active sentinel surveillance system implemented in 35 hospitals across six EU/EEA countries. We aim to measure pertussis vaccines effectiveness (VE) by dose against hospitalisation in infants aged <1 year. METHODS: From December 2015 to December 2019, participating hospitals recruited all infants with pertussis-like symptoms. Cases were vaccine-eligible infants testing positive for Bordetella pertussis by PCR or culture; controls were those testing negative to all Bordetella spp. For each vaccine dose, we defined an infant as vaccinated if she/he received the corresponding dose >14 days before symptoms. Unvaccinated were those who did not receive any dose. We calculated (one-stage model) pooled VE as 100*(1-odds ratio of vaccination) adjusted for country, onset date (in 3-month categories) and age-group (when sample allowed it). RESULTS: Of 1,393 infants eligible for vaccination, we included 259 cases and 746 controls. Median age was 16 weeks for cases and 19 weeks for controls (p < 0.001). Median birth weight and gestational age were 3,235 g and week 39 for cases, 3,113 g and week 39 for controls. Among cases, 119 (46 %) were vaccinated: 74 with one dose, 37 two doses, 8 three doses. Among controls, 469 (63 %) were vaccinated: 233 with one dose, 206 two doses, 30 three doses. Adjusted VE after at least one dose was 59 % (95 %CI: 36-73). Adjusted VE was 48 % (95 %CI: 5-71) for dose one (416 eligible infants) and 76 % (95 %CI: 43-90) for dose two (258 eligible infants). Only 42 infants were eligible for the third dose. CONCLUSIONS: Our results suggest moderate one-dose and two-dose VE in infants. Larger sample size would allow more precise estimates for dose one, two and three.

Hospitalisations and Deaths Averted by COVID-19 Vaccination in Navarre, Spain, 2021-2022.

In 2021-2022, most of the Spanish population received COVID-19 vaccines and a high proportion of them had SARS-CoV-2 infection. We estimated the rate of hospitalisations and deaths that were averted by risk reduction among vaccinated COVID-19 cases. Hospitalisations and deaths were analysed among COVID-19 cases confirmed in 2021 and 2022 in Navarre, Spain. To calculate the number of prevented outcomes by sex, age, comorbidities, and semester, the difference in the risk of each outcome between unvaccinated and vaccinated cases was multiplied by the number of vaccinated cases. COVID-19 vaccination coverage with any dose reached 88%, 86% with full vaccination, and 56% with a booster dose. The cumulative rates per 1000 inhabitants were 382 COVID-19 confirmed cases, 6.70 hospitalisations, and 1.15 deaths from COVID-19. The estimated rates of prevented events by vaccination were 16.33 hospitalisations and 3.39 deaths per 1000 inhabitants, which was 70.9% and 74.7% of expected events without vaccination, respectively. People aged 80 years and older or with major chronic conditions accounted for the majority of hospitalizations and deaths prevented by COVID-19 vaccination. One hospitalisation and death due to COVID-19 were averted for every 53 and 258 people vaccinated, respectively. The high COVID-19 vaccine effect in reducing the risk of severe outcomes and the high vaccination coverage in risk populations prevented three out of four hospitalisations and deaths due to COVID-19 during a period of intense circulation of SARS-CoV-2.

Influenza Vaccine Effectiveness in Preventing Laboratory-Confirmed Influenza Cases and Hospitalizations in Navarre, Spain, 2022-2023.

We estimated influenza vaccine effectiveness (IVE) in preventing outpatient and hospitalized cases in the 2022-2023 season. A test-negative design included a representative sample of outpatients and all hospitalized patients with influenza-like illness (ILI) from October 2022 to May 2023 in Navarre, Spain. ILI patients were tested by PCR for influenza virus. Influenza vaccination status was compared between confirmed influenza cases and test-negative controls. Among 3321 ILI patients tested, IVE to prevent influenza cases was 34% (95% confidence interval (CI): 16 to 48) overall, 85% (95%CI: 63 to 94) against influenza B, and 28% (95%CI: 3 to 46) against A(H3N2). Among 558 outpatients, 222 (40%) were confirmed for influenza: 55% A(H3N2), 11% A(H1N1), and 31% B. Overall, IVE to prevent outpatient cases was 48% (95%CI: 8 to 70), 88% (95%CI: 3 to 98) against influenza B, and 50% (95%CI: -4 to 76) against A(H3N2). Of 2763 hospitalized patients, 349 (13%) were positive for influenza: 64% A(H3N2), 17% A(H1N1), and 8% B. IVE to prevent hospitalization was 24% (95%CI: -1 to 42) overall, 82% (95%CI: 49 to 93) against influenza B, and 16% (95%CI: -17 to 40) against A(H3N2). No IVE was observed in preventing influenza A(H1N1). IVE was high to prevent influenza B, moderate against A(H3N2) and null against A(H1N1). A lower proportion of influenza B cases may explain the smaller IVE in hospitalized patients than in outpatients. The null IVE against A(H1N1) was consistent with the observed antigenic drift and supports the new composition of the 2023-2024 influenza vaccine.

Risk reduction of hospitalisation and severe disease in vaccinated COVID-19 cases during the SARS-CoV-2 variant Omicron BA.1-predominant period, Navarre, Spain, January to March 2022.

BackgroundAs COVID-19 vaccine effectiveness against SARS-CoV-2 infection was lower for cases of the Omicron vs the Delta variant, understanding the effect of vaccination in reducing risk of hospitalisation and severe disease among COVID-19 cases is crucial.AimTo evaluate risk reduction of hospitalisation and severe disease in vaccinated COVID-19 cases during the Omicron BA.1-predominant period in Navarre, Spain.MethodsA case-to-case comparison included COVID-19 epidemiological surveillance data in adults ≥ 18 years from 3 January-20 March 2022. COVID-19 vaccination status was compared between hospitalised and non-hospitalised cases, and between severe (intensive care unit admission or death) and non-severe cases using logistic regression models.ResultsAmong 58,952 COVID-19 cases, 565 (1.0%) were hospitalised and 156 (0.3%) were severe. The risk of hospitalisation was reduced within the first 6 months after full COVID-19 vaccination (complete primary series) (adjusted odds ratio (aOR): 0.06; 95% CI: 0.04-0.09) and after 6 months (aOR: 0.16; 95% CI: 0.12-0.21; pcomparison < 0.001), as well as after a booster dose (aOR: 0.06: 95% CI: 0.04-0.07). Similarly, the risk of severe disease was reduced (aOR: 0.13, 0.18, and 0.06, respectively). Compared with cases fully vaccinated 6 months or more before a positive test, those who had received a booster dose had lower risk of hospitalisation (aOR: 0.38; 95% CI: 0.28-0.52) and severe disease (aOR: 0.38; 95% CI: 0.21-0.68).ConclusionsFull COVID-19 vaccination greatly reduced the risk of hospitalisation and severe outcomes in COVID-19 cases with the Omicron variant, and a booster dose improved this effect in people aged over 65 years.

Effect of COVID-19 vaccination on the SARS-CoV-2 transmission among social and household close contacts: A cohort study.

BACKGROUND: COVID-19 vaccination was expected to reduce SARS-CoV-2 transmission, but the relevance of this effect remains unclear. We aimed to estimate the effectiveness of COVID-19 vaccination of the index cases and their close contacts in reducing the probability of SARS-CoV-2 transmission. METHODS: Transmission of SARS-CoV-2 infection was evaluated in two cohorts of adult close contacts of COVID-19 confirmed cases (social and household settings) by COVID-19 vaccination status of the index case and the close contact, from April to November 2021 in Navarre, Spain. The effects of vaccination of the index case and the close contact were estimated as (1-adjusted relative risk) × 100%. RESULTS: Among 19,631 social contacts, 3257 (17%) were confirmed with SARS-CoV-2. COVID-19 vaccination of the index case reduced infectiousness by 44% (95% CI, 27-57%), vaccination of the close contact reduced susceptibility by 69% (95% CI, 65-73%), and vaccination of both reduced transmissibility by 74% (95% CI, 70-78%) in social settings, suggesting some synergy of effects. Among 20,708 household contacts, 6269 (30%) were infected, and vaccine effectiveness estimates were 13% (95% CI, -5% to 28%), 61% (95% CI, 58-64%), and 52% (95% CI, 47-56%), respectively. These estimates were lower in older people and had not relevant differences between the Alpha (April-June) and Delta (July-November) variant periods. CONCLUSIONS: COVID-19 vaccination reduces infectiousness and susceptibility; however, these effects are insufficient for complete control of SARS-CoV-2 transmission, especially in older people and household setting. Relaxation of preventive behaviors after vaccination may counteract part of the vaccine effect on transmission.

Comparison of the Risk of Hospitalization and Severe Disease Among Co-circulating Severe Acute Respiratory Syndrome Coronavirus 2 Variants.

BACKGROUND: We compare the risk of coronavirus disease 2019 (COVID-19) outcomes among co-circulating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants between January 2021 and May 2022 in Navarra, Spain. METHODS: We compared the frequency of hospitalization and severe disease (intensive care unit admission or death) due to COVID-19 among the co-circulating variants. Variants analyzed were nonvariants of concern (non-VOCs), Alpha, Delta, Omicron BA.1, and Omicron BA.2. Logistic regression models were used to estimate adjusted odds ratio (aOR). RESULTS: The Alpha variant had a higher risk of hospitalization (aOR, 1.86 [95 confidence interval {CI}, 1.282.71]) and severe disease (aOR, 2.40 [95 CI, 1.314.40]) than non-VOCs. The Delta variant did not show a significantly different risk of hospitalization (aOR, 0.73 [95 CI, .401.30]) and severe disease (aOR, 3.04 [95 CI, .5716.22]) compared to the Alpha variant. The Omicron BA.1 significantly reduced both risks relative to the Delta variant (aORs, 0.28 [95 CI, .16.47] and 0.23 [95 CI, .12.46], respectively). The Omicron BA.2 reduced the risk of hospitalization compared to BA.1 (aOR, 0.52 [95 CI, .29.95]). CONCLUSIONS: The Alpha and Delta variants showed an increased risk of hospitalization and severe disease, which decreased considerably with the Omicron BA.1 and BA.2. Surveillance of variants can lead to important differences in severity.

Seroprevalence of antibodies against SARS-CoV-2 and risk of COVID-19 in Navarre, Spain, May to July 2022.

In Navarre, Spain, in May 2022, the seroprevalence of anti-nucleocapsid (N) and anti-spike (S) antibodies of SARS-CoV-2 was 58.9% and 92.7%, respectively. The incidence of confirmed COVID-19 thereafter through July was lower in people with anti-N antibodies (adjusted odds ratio (aOR) = 0.08; 95% confidence interval (CI): 0.05-0.13) but not with anti-S antibodies (aOR = 1.06; 95% CI: 0.47-2.38). Hybrid immunity, including anti-N antibodies induced by natural exposure to SARS-CoV-2, seems essential in preventing Omicron COVID-19 cases.

Effectiveness of influenza vaccination in preventing influenza in primary care, Navarre, Spain, 2021/22.

Compared with individuals unvaccinated in the current and three previous influenza seasons, in 2021/22, influenza vaccine effectiveness at primary care level was 37% (95% CI: 16 to 52) for current season vaccination, regardless of previous doses, and 35% (95% CI: -3 to 45) for only previous seasons vaccination. Against influenza A(H3N2), estimates were 39% (95% CI: 16 to 55) and 24% (95% CI: -8 to 47) suggesting moderate effectiveness of current season vaccination and possible remaining effect of prior vaccinations.

Differences in Transmission between SARS-CoV-2 Alpha (B.1.1.7) and Delta (B.1.617.2) Variants.

The present study aimed to compare the susceptibility and infectivity between the Alpha and Delta variants of SARS-CoV-2 and to investigate characteristics of the index case and the contact that may affect transmission. The risk of SARS-CoV-2 infection was compared between close contacts of COVID-19 cases with Alpha and Delta variants during June 2021 to August 2021. In index cases, Spike gene target failure (TaqPath) was used as a proxy of Alpha variant and the L452R mutation (TaqMan) for Delta variant. Cox regression models were used to estimate adjusted relative risks (RR). We compared close contacts of index cases with Alpha (n = 2139) and Delta variants (n = 5439). Delta variant was more transmissible overall (relative risk [RR] 1.32, 95% CI = 1.13 to 1.53), and in non-household contacts (RR 1.71, 95% CI = 1.35 to 2.16), but not in household contacts (RR 1.10, 95% CI = 0.91 to 1.34; Pinteraction < 0.001). Delta variant excess transmission was observed when the index cases were 12 to 39 years old (RR 1.51, 95% CI = 1.27 to 1.79) and the close contacts were 18 to 39 years old (RR 1.62, 95% CI = 1.29 to 2.03), but not among those younger or older than such ages. Differences in transmissibility between variants disappeared with vaccination of the index case (RR 0.68, 95% CI = 0.46 to 1.02), but not with vaccination of the close contact. This report shows that the Delta variant is more transmissible than Alpha variant mainly among young adults. Vaccination of the index cases reduced the excess transmission, which reinforces the recommendation of vaccination to reduce transmission of the Delta variant. IMPORTANCE The higher transmissibility of the Delta variant of SARS-CoV-2 in comparison with the Alpha variant has been reported. We compared the transmission of the Alpha and Delta variants by characteristics and COVID-19 vaccination status of index cases and their close contacts. Interestingly, the Delta variant showed increased transmissibility when the index case was an adolescent or young adult and when the close contact was a young adult; however, in index cases and close contacts of other age groups, transmission did not differ between variants. This may explain the increased proportion of young people who have been infected in the surges due to the Delta variant. The Delta variant was more transmissible than the Alpha variant when the index cases were unvaccinated against COVID-19, and their vaccination equaled the transmissibility of both variants, which suggests a higher impact of vaccination in controlling transmission of the Delta variant.

Chronic obstructive pulmonary disease and influenza vaccination effect in preventing outpatient and inpatient influenza cases.

Evidence of influenza vaccine effectiveness in preventing confirmed influenza among persons diagnosed with chronic obstructive pulmonary disease (COPD) is scarce. We assessed the average effect of influenza vaccination in the current and prior seasons in preventing laboratory-confirmed influenza in COPD patients. We carried out a pooled test-negative case-control design in COPD patients hospitalized or presented to primary healthcare centres with influenza-like illness who were tested for influenza in 2015/2016 to 2019/2020 seasons in Navarre, Spain. Influenza vaccination status in the current and 5 prior seasons was compared between confirmed-influenza cases and test-negative controls. Vaccination effect was compared between target patients for vaccination with and without COPD. Out of 1761 COPD patients tested, 542 (31%) were confirmed for influenza and 1219 were test-negative controls. Average effect for current-season vaccination in preventing influenza was 40% (95% CI 20-54%), and for vaccination in prior seasons only was 24% (95% CI -10 to 47%). Point estimates seemed higher in preventing outpatient cases (60% and 58%, respectively) than inpatient cases (37% and 19%, respectively), but differences were no statistically significant. Influenza vaccination effect was similar in target population with and without COPD (p = 0.339). Influenza vaccination coverage in control patients with COPD was 68.3%. A 13.7% of the influenza cases in patients with COPD could be prevented by extending the influenza vaccine coverage. Average effect of current-season influenza vaccination was moderate to prevent influenza in COPD persons. The increase of influenza vaccination coverage can still prevent COPD exacerbations.

Utility of a commercial RT-qPCR assay to detect SARS-CoV-2 gene variations as an indicator of lineages.

BACKGROUND: The World Health Organization (WHO) recommended RT-qPCR tests as the reference technique for SARS-CoV-2 molecular detection, however with the rapid spread of the infection, mutations in specific RT-qPCR target regions have been widely described could allow the presumptive identification. OBJECTIVE: In this study, we evaluated the analytical performance of the Allplex™SARS-CoV-2/FluA/FluB/RSV assay for the additional presumptive identification of SARS-CoV-2 variants in a real-life setting. RESULTS: We observed gene-specific changes in the cycle threshold (Ct) of the N and RdRp genes compared with the Ct yielded for the S gene when the SARS-CoV-2 testing was performed Allplex™SARS-CoV-2/FluA/FluB/RSV assay. Seventeen samples showed Ct variations in the N and/or RdRp. In 10 cases, the N gene was affected, delayed or negative and in 14 cases, the RdRp gene showed a delay or negative concerning the S gene. A delay in the Ct of both genes (RdRp and N) was observed in six cases. Sequencing determined that all samples identified as B.1.1.7 showed changes in the PCR curves of the N and RdRp. However, samples identified as B.1.177 only showed variations for the RdRp gene. CONCLUSIONS: Allplex™SARS-CoV-2/FluA/FluB/RSV assay, the diagnosis could presumably allow the rapid assignment of lineages B.1.1.7 and B.1.177, and emphasizes the importance of exhaustive surveillance for circulating variants of the SARS-CoV-2 virus to reduce community transmission.

Product-specific COVID-19 vaccine effectiveness against secondary infection in close contacts, Navarre, Spain, April to August 2021.

COVID-19 vaccine effectiveness by product (two doses Comirnaty, Spikevax or Vaxzevria and one of Janssen), against infection ranged from 50% (95% CI: 42 to 57) for Janssen to 86% (70 to 93) for Vaxzevria-Comirnaty combination; among ≥ 60 year-olds, from 17% (-26 to 45) for Janssen to 68% (48 to 80) for Spikevax; and against hospitalisation from 74% (43 to 88) for Janssen to > 90% for other products. Two doses of vaccine were highly effective against hospitalisation, but suboptimal for infection control.

Emergence of SARS-CoV-2 Variant B.1.575.2, Containing the E484K Mutation in the Spike Protein, in Pamplona, Spain, May to June 2021.

With the emergence of new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and the acquisition of novel mutations in existing lineages, the need to implement methods capable of monitoring viral dynamics arises. We report the emergence and spread of a new SARS-CoV-2 variant within the B.1.575 lineage, containing the E484K mutation in the spike protein (named B.1.575.2), in a region in northern Spain in May and June 2021. SARS-CoV-2-positive samples with cycle threshold values of ≤30 were selected to screen for presumptive variants using the TaqPath coronavirus disease 2019 (COVID-19) reverse transcription (RT)-PCR kit and the TaqMan SARS-CoV-2 mutation panel. Confirmation of variants was performed by whole-genome sequencing. Of the 200 samples belonging to the B.1.575 lineage, 194 (97%) corresponded to the B.1.575.2 sublineage, which was related to the presence of the E484K mutation. Of 197 cases registered in the Global Initiative on Sharing Avian Influenza Data (GISAID) EpiCoV database as lineage B.1.575.2, 194 (99.5%) were identified in Pamplona, Spain. This report emphasizes the importance of complementing surveillance of SARS-CoV-2 with sequencing for the rapid control of emerging viral variants.

Simple models to include influenza vaccination history when evaluating the effect of influenza vaccination.

BackgroundMost reports of influenza vaccine effectiveness consider current-season vaccination only.AimWe evaluated a method to estimate the effect of influenza vaccinations (EIV) considering vaccination history.MethodsWe used a test-negative design with well-documented vaccination history to evaluate the average EIV over eight influenza seasons (2011/12-2018/19; n = 10,356). Modifying effect was considered as difference in effects of vaccination in current and previous seasons and current-season vaccination only. We also explored differences between current-season estimates excluding from the reference category people vaccinated in any of the five previous seasons and estimates without this exclusion or only for one or three previous seasons.ResultsThe EIV was 50%, 45% and 38% in people vaccinated in the current season who had previously received none, one to two and three to five doses, respectively, and it was 30% and 43% for one to two and three to five prior doses only. Vaccination in at least three previous seasons reduced the effect of current-season vaccination by 12 percentage points overall, 31 among outpatients, 22 in 9-65 year-olds, and 23 against influenza B. Including people vaccinated in previous seasons only in the unvaccinated category underestimated EIV by 9 percentage points on average (31% vs 40%). Estimates considering vaccination of three or five previous seasons were similar.ConclusionsVaccine effectiveness studies should consider influenza vaccination in previous seasons, as it can retain effect and is often an effect modifier. Vaccination status in three categories (current season, previous seasons only, unvaccinated) reflects the whole EIV.

Effect of influenza vaccination in patients with asthma.

BACKGROUND: Although annual influenza vaccination is recommended for persons with asthma, its effectiveness in this patient population is not well described. We evaluated the effect of influenza vaccination in the current and previous seasons in preventing influenza among people with asthma. METHODS: Using population health data from the Navarre region of Spain for the 2015/16 to 2019/20 influenza seasons, we conducted a test-negative case-control study to assess the effect of influenza vaccination in the current and 5 previous seasons. From patients presenting to hospitals and primary health care centres with influenza-like illness who underwent testing for influenza, we estimated the effects of influenza vaccination among patients with asthma overall and between those presenting as inpatients or outpatients, as well as between patients with and without asthma. RESULTS: Of 1032 patients who had asthma and were tested, we confirmed that 421 had influenza and the remaining 611 were test-negative controls. We found that the average effect of influenza vaccination was 43% (adjusted odds ratio [OR] 0.57, 95% confidence interval [CI] 0.40 to 0.80) for current-season vaccination regardless of previous doses, and 38% (adjusted OR 0.62, 95% CI 0.39 to 0.96) for vaccination in previous seasons only. Effects were similar for outpatients and inpatients. Among patients with asthma and confirmed influenza, current-season vaccination did not reduce the odds of hospital admission (adjusted OR 1.05, 95% CI 0.51 to 2.18). Influenza vaccination effects were similar for patients with and without asthma. INTERPRETATION: We estimated that, on average, current or previous influenza vaccination of people with asthma prevented almost half of influenza cases. These results support recommendations that people with asthma receive influenza vaccination.

Risk Factors of Infection, Hospitalization and Death from SARS-CoV-2: A Population-Based Cohort Study.

We conducted a prospective population-based cohort study to assess risk factors for infection, hospitalization, and death from SARS-CoV-2. The study comprised the people covered by the Health Service of Navarre, Spain. Sociodemographic variables and chronic conditions were obtained from electronic healthcare databases. Confirmed infections, hospitalizations, and deaths from SARS-CoV-2 were obtained from the enhanced epidemiological surveillance during the second SARS-CoV-2 epidemic surge (July-December 2020), in which diagnostic tests were widely available. Among 643,757 people, 5497 confirmed infections, 323 hospitalizations, 38 intensive care unit admissions, and 72 deaths from SARS-CoV-2 per 100,000 inhabitants were observed. A higher incidence of confirmed infection was associated with people aged 15-29 years, nursing home residents, healthcare workers, people born in Latin America or Africa, as well as in those diagnosed with diabetes, cardiovascular disease, chronic obstructive pulmonary disease (COPD), chronic kidney disease, dementia, severe obesity, hypertension and functional dependence. The risk of hospitalization in the population was associated with males, higher age, nursing home residents, Latin American or African origin, and those diagnosed with immunodeficiency, diabetes, cardiovascular disease, COPD, asthma, kidney disease, cerebrovascular disease, cirrhosis, dementia, severe obesity, hypertension and functional dependence. The risk of death was associated with males, higher age, nursing home residents, Latin American origin, low income level, immunodeficiency, diabetes, cardiovascular disease, COPD, kidney disease, dementia, and functional dependence. This study supports the prioritization of the older population, nursing home residents, and people with chronic conditions and functional dependence for SARS-CoV-2 prevention and vaccination, and highlights the need for additional preventive support for immigrants.

Effectiveness of COVID-19 vaccines in preventing SARS-CoV-2 infection and hospitalisation, Navarre, Spain, January to April 2021.

COVID-19 vaccine effectiveness was evaluated in close contacts of cases diagnosed during January-April 2021. Among 20,961 contacts, 7,240 SARS-CoV-2 infections were confirmed, with 5,467 being symptomatic and 559 leading to hospitalisations. Non-brand-specific one and two dose vaccine effectiveness were respectively, 35% (95% confidence interval (CI): 25 to 44) and 66% (95% CI: 57 to 74) against infections, 42% (95% CI: 31 to 52) and 82% (95% CI: 74 to 88) against symptomatic infection, and 72% (95% CI: 47 to 85) and 95% (95% CI: 62 to 99) against COVID-19 hospitalisation. The second dose significantly increased effectiveness. Findings support continuing complete vaccination.

Surveillance for Enteroviruses Associated with Hand, Foot, and Mouth Disease, and Other Mucocutaneous Symptoms in Spain, 2006-2020.

Hand, foot, and mouth disease (HFMD) is a mild illness caused by enteroviruses (EV), although in some Asian countries, large outbreaks have been reported in the last 25 years, with a considerable incidence of neurological complications. This study describes epidemiological and clinical characteristics of EV infections involved in HFMD and other mucocutaneous symptoms from 2006 to 2020 in Spain. EV-positive samples from 368 patients were included. EV species A were identified in 85.1% of those typed EV. Coxsackievirus (CV) A6 was the prevalent serotype (60.9%), followed by EV-A71 (9.9%) and CVA16 (7.7%). Infections affected children (1-6 years old) mainly, and show seasonality with peaks in spring-summer and autumn. Clinical data indicated few cases of atypical HFMD as well as those with neurological complications (associated with the 2016 EV-A71 outbreak). Phylogenetic analysis of CVA6 VP1 sequences showed different sub-clusters circulating from 2010 to present. In conclusion, HFMD or exanthemas case reporting has increased in Spain in recent years, probably associated with an increase in circulation of CVA6, although they did not seem to show greater severity. However, EV surveillance in mucocutaneous manifestations should be improved to identify the emergence of new types or variants causing outbreaks and more severe pathologies.

Effectiveness of palivizumab in preventing respiratory syncytial virus infection in high-risk children.

To date, there is no consensus regarding palivizumab prophylaxis for respiratory syncytial virus infection. The purpose of this study is to assess the effectiveness of palivizumab prophylaxis to prevent respiratory syncytial virus-related infection consultations and hospitalizations in high-risk children <2 y. We studied children <2 y of age with risk factors who had indication of palivizumab prophylaxis over eight epidemic seasons (2011-2012 to 2018-2019) in Navarra, Spain. Children positives for respiratory syncytial virus by reverse-transcription polymerase chain reaction were compared to negative testers. Palivizumab was indicated in 1,214 children <2 y of age with risk factors during 2011-2012 to 2018-2019 seasons. A total of 142 high-risk children tested for respiratory syncytial virus were included in the study. From the 35 respiratory syncytial virus-positive confirmed cases, 20 (57%) had received palivizumab versus 82 (77%) from the 107 negative controls. The effectiveness of prophylactic palivizumab was 70% (95% CI, 19%-90%) in preventing confirmed clinical infection and 82% (95% CI, 29%-96%) in preventing hospitalized cases. Our results show that palivizumab is notably effective for preventing laboratory-confirmed cases of respiratory syncytial virus and hospitalization in high-risk children <2 y of age. For children who have received palivizumab, the risk of getting sick remains high; thus, other preventive measures are necessary.