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Front Psychol ; 12: 755965, 2021.
Article in English | MEDLINE | ID: covidwho-1528859


Background: The COVID-19 pandemic has caused mental health problems worldwide. The psychopathological implications of COVID-19 in cancer patients have rarely been addressed. Considering the increased vulnerability of oncology patients, this issue needs to be addressed to improve the long-term mental health status of these patients. Methods: We conducted a prospective study in outpatients under active cancer treatment during the first wave of the COVID-19 pandemic. A semi-structured 24-question survey was designed to measure baseline sociodemographic, psychosocial and COVID-19 exposure characteristics. The Hospital Anxiety and Depression Scale was used to measure psychological symptoms. A descriptive and analytical univariate analysis of the variables studied was performed. We used the Z-score to compare different populations (experimental and historical control cohort). Results: 104 patients were included, the majority of which were women (64.4%), were above 65 years of age (57.7%), had either lung and breast cancer (56.7%), had advanced disease (64%) and were undergoing chemotherapy (63.5%). 51% of them expressed greater fear of cancer than of COVID-19 infection or both. In relation to HADS, 52.8% of emotional distress, 42.3% of anxiety and 58.6% of depression rates were detected. The main factors related with higher rates of psychological symptomatology were history of previous psychotropic drug consumption and the adoption of additional infection prevention measures because they considered themselves at risk of severe COVID-19 infection (p = 0.008; p = 0.003 for emotional distress, p = 0.026; p = 0.004 for anxiety, and p = 0.013; p = 0.008 for depression). Tumor type, stage, oncologic treatment or rescheduling of cancer treatments were not related to higher levels of psychological symptomatology. Comparison of our results with another population of similar characteristics was not significant (Z score = -1.88; p = 0.060). Conclusions: We detected high rates of emotional distress during the first wave of the COVID-19 pandemic among cancer patients in active treatment (52.8%). This was higher and clinically relevant than observed in a comparable population (42.5%), although not significant. Cancer itself is the main factor of concern for cancer patients, above and beyond the emotional distress generated by COVID-19 pandemic.

N Engl J Med ; 2021 Nov 09.
Article in English | MEDLINE | ID: covidwho-1506999


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; number, NCT04816643.).

Clin Infect Dis ; 72(9): e397-e401, 2021 05 04.
Article in English | MEDLINE | ID: covidwho-1387751


Some clusters of children with a multisystem inflammatory syndrome (MIS-C) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection have been reported. We describe the epidemiological and clinical features of children with MIS-C in Spain. MIS-C is a potentially severe condition that presents in children with recent SARS-CoV-2 infection.

COVID-19 , SARS-CoV-2 , Child , Humans , Spain/epidemiology , Syndrome , Systemic Inflammatory Response Syndrome