BACKGROUND AND OBJECTIVES: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials. METHODS: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed. RESULTS: The CVM study enrolled 658 first-dose vaccinees (children aged 5-11 years; n = 250 and adolescents aged 12-17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000. CONCLUSIONS: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

BACKGROUND: Chronic pain and depression are frequent comorbidities in primary care. Depression among other psychosocial factors play a role in the clinical course of chronic pain. OBJECTIVE: To study the short and long-term predictive factors of severity and interference of chronic pain in primary care patients with chronic musculoskeletal pain and major depression. METHODS: Longitudinal study of a cohort of 317 patients. The outcomes are severity and functional interference of pain (Brief Pain Inventory) measured at 3 and 12 months. We performed multivariate linear regression models to estimate the effects the explanatory baseline variables on the outcomes. RESULTS: 83% participants were women; average age was 60.3 years (SD = 10.2). In multivariate models, baseline pain severity predicted pain severity at 3 months (ß = 0.53; 95% CI = 0.37-0.68) and at 12 months (ß = 0.48; 95% CI = 0.29-0.67). Also, pain > 2 years of evolution predicted long term pain severity (ß = 0.91; CI95%=0.11-1.71). Baseline pain interference predicted interference at 3 and 12 months (ß = 0.27; 95%CI = 0.11-0.43 and ß = 0.21; 95%CI = 0.03-0.40, respectively). Baseline pain severity predicted interference at 3 and 12 months (ß = 0.26; 95%CI = 0.10-0.42 and ß = 0.20; 95%CI = 0.02-0.39, respectively). Pain > 2 years predicted greater severity and greater interference at 12 months (ß = 0.91; CI95%=0.11-1.71, and ß = 1.23; CI95%=0.41-2.04). Depression severity predicted more interference at 12 months (ß = 0.58; CI95%=0.04-1.11). Occupational status as active worker predicted less interference throughout the follow-up (ß=-0.74; CI95%=-1.36 to -0.13 and ß=-0.96; CI95%=-1.71 to -0.21, at 3 and 12 months). Currently working also predicts less pain severity at 12 months (ß=-0.77; CI95%=1.52 – 0.02). With regard to the psychological variables, pain catastrophizing predicted pain severity and interference at three months (ß = 0.03; 95% CI = 0.00-0.05 and ß = 0.03; 95% CI = 0.00-0.05), but not at long term. CONCLUSION: In a sample of adults with chronic pain and depression, this primary care study has identified prognostic factors that independently predict the severity and functional interference of pain. If confirmed in new studies, these factors should be targeted for individualized interventions. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02605278), registered 16/11/2015.

Background Waist-to-height ratio (WHtR) predicts abdominal fat and cardiometabolic risk. In children with obesity, the most adequate cut-off to predict cardiometabolic risk as well as its ability to predict risk changes over time has not been tested. Our aim was to define an appropriate WHtR cut-off to predict cardiometabolic risk in children with obesity, and to analyze its ability to predict changes in cardiometabolic risk over time. Methods This is an observational prospective study secondary to the OBEMAT2.0 trial. We included data from 218 participants (8-15 years) who attended baseline and final visits (12 months later). The main outcome measure was a cardiometabolic risk score derived from blood pressure, lipoproteins, and HOMA index of insulin resistance. Results The optimal cut-off to predict the cardiometabolic risk score was WHtR >= 0.55 with an area under the curve of 0.675 (95% CI: 0.589-0.760) at baseline and 0.682 (95% CI: 0.585-0.779) at the final visit. Multivariate models for repeated measures showed that changes in cardiometabolic risk were significantly associated with changes in WHtR. Conclusion This study confirms the clinical utility of WHtR to predict changes in cardiometabolic risk over time in children with obesity. The most accurate cut-off to predict cardiometabolic risk in children with obesity was WHtR >= 0.55. Impact In children, there is no consensus on a unique WHtR cut-off to predict cardiometabolic risk. The present work provides sufficient evidence to support the use of the 0.55 boundary. We have a large sample of children with obesity, with whom we compared the previously proposed boundaries according to cardiometabolic risk, and we found the optimal WHtR cut-off to predict it. We also analyzed if a reduction in the WHtR was associated with an improvement in their cardiometabolic profile.

Several population-specific genetic, sociodemographic, and maternal lifestyle factors are related to iron status in early pregnancy, and their identification would allow preventive actions to be taken. The study aimed to identify maternal factors associated with iron deficiency (ID) in early pregnancy in non-anaemic pregnant women from a European Mediterranean country. Cross-sectional study using the initial population of the ECLIPSES study performed in non-anaemic pregnant women before gestational week 12. Serum ferritin (SF) and haemoglobin concentrations were measured to evaluate iron status, and ID was defined as SF < 15 mu g/L. Several sociodemographic and lifestyle data were recorded and used as covariates in the multivariate-adjusted regression models. Out of the 791 participants, 13.9% had ID in early pregnancy. Underweight (OR 3.70, 95%CI 1.22, 15.53) and parity (1 child: OR 2.03, 95%CI 1.06, 3.88; >= 2 children: OR 6.96, 95%CI 3.09, 15.69) increased the odds of ID, while a high intake of total meat (>= 108.57 g/day: OR 0.37, 95%CI 0.15, 0.87), red/processed meat (>= 74.29 g/ day: OR 0.70, 95%CI 0.35, 0.98), protein (>= 65.05 g/day: OR 0.85, 95%CI 0.30, 0.99), and dietary iron (>= 8.58 mg/day: OR 0.58, 95%CI 0.35, 0.94) protected against it. Smoking was also associated with a reduction in ID odds (OR 0.34, 95%CI 0.12, 0.99). Baseline BMI, parity, smoking, and diet are associated with ID in early pregnancy in non-anaemic women. Pregnancy planning policies should focus on women at higher risk of ID, such as those who are underweight, multiparous, or following vegetarian diets. This clinical trial was registered at www.clinicaltrialsregister.eu as EudraCT number 2012-005,480-28 and at www.clinicaltrials.gov with identification number NCT03196882.

Background: Previous studies have shown that adherence to the Mediterranean Diet (MeDi) has a positive impact on lung function in subjects with lung disease. In subjects free of respiratory diseases, but at risk, this association is not yet well established. Methods: Based on the reference data from the MEDISTAR clinical trial (Mediterranean Diet and Smoking in Tarragona and Reus; ISRCTN 03.362.372), an observational study was conducted with 403 middle-aged smokers without lung disease, treated at 20 centres of primary care in Tarragona (Catalonia, Spain). The degree of MeDi adherence was evaluated according to a 14-item questionnaire, and adherence was defined in three groups (low, medium, and high). Lung function were assessed by forced spirometry. Logistic regression and linear regression models were used to analyse the association between adherence to the MeDi and the presence of ventilatory defects. Results: Globally, the pulmonary alteration prevalence (impaired FEV1 and/or FVC) was 28.8%, although it was lower in participants with medium and high adherence to the MeDi, compared to those with a low score (24.2% and 27.4% vs. 38.5%, p = 0.004). Logistic regression models showed a significant and independent association between medium and high adherence to the MeDi and the presence of altered lung patterns (OR 0.467 [95%CI 0.266, 0.820] and 0.552 [95%CI 0.313, 0.973], respectively). Conclusions: MeDi adherence is inversely associated with the risk impaired lung function. These results indicate that healthy diet behaviours can be modifiable risk factors to protect lung function and reinforce the possibility of a nutritional intervention to increase adherence to MeDi, in addition to promoting smoking cessation.