ImportanceGreater than 20% of cases and 0.4% of deaths from COVID-19 occur in children. Following demonstration of the safety and efficacy of the adjuvanted, recombinant spike protein vaccine NVX-CoV2373 in adults, the PREVENT-19 trial immediately expanded to adolescents.ObjectiveTo evaluate the safety, immunogenicity, and efficacy of NVX-CoV2373 in adolescents.Design, Setting, and ParticipantsThe NVX-CoV2373 vaccine was evaluated in adolescents aged 12 to 17 years in an expansion of PREVENT-19, a phase 3, randomized, observer-blinded, placebo-controlled multicenter clinical trial in the US. Participants were enrolled from April 26 to June 5, 2021, and the study is ongoing. A blinded crossover was implemented after 2 months of safety follow-up to offer active vaccine to all participants. Key exclusion criteria included known previous laboratory-confirmed SARS-CoV-2 infection or known immunosuppression. Of 2304 participants assessed for eligibility, 57 were excluded and 2247 were randomized.InterventionsParticipants were randomized 2:1 to 2 intramuscular injections of NVX-CoV2373 or placebo, 21 days apart.Main Outcomes and MeasuresSerologic noninferiority of neutralizing antibody responses compared with those in young adults (aged 18-25 years) in PREVENT-19, protective efficacy against laboratory-confirmed COVID-19, and assessment of reactogenicity and safety.ResultsAmong 2232 participants (1487 NVX-CoV2373 and 745 placebo recipients), the mean (SD) age was 13.8 (1.4) years, 1172 (52.5%) were male, 1660 (74.4%) were White individuals, and 359 (16.1%) had had a previous SARS-CoV-2 infection at baseline. After vaccination, the ratio of neutralizing antibody geometric mean titers in adolescents compared with those in young adults was 1.5 (95% CI, 1.3-1.7). Twenty mild COVID-19 cases occurred after a median of 64 (IQR, 57-69) days of follow-up, including 6 among NVX-CoV2373 recipients (incidence, 2.90 [95% CI, 1.31-6.46] cases per 100 person-years) and 14 among placebo recipients (incidence, 14.20 [95% CI, 8.42-23.93] cases per 100 person-years), yielding a vaccine efficacy of 79.5% (95% CI, 46.8%-92.1%). Vaccine efficacy for the Delta variant (the only viral variant identified by sequencing [n = 11]) was 82.0% (95% CI, 32.4%-95.2%). Reactogenicity was largely mild to moderate and transient, with a trend toward greater frequency after the second dose of NVX-CoV2373. Serious adverse events were rare and balanced between treatments. No adverse events led to study discontinuation.Conclusions and RelevanceThe findings of this randomized clinical trial indicate that NVX-CoV2373 is safe, immunogenic, and efficacious in preventing COVID-19, including the predominant Delta variant, in adolescents.Trial RegistrationClinicalTrials.gov Identifier: NCT04611802
Introducción: se carece de guías clínicas claras para la solicitud de pruebas tiroideas en pacientes hospitalizados. Se evaluó el nivel de pertinencia y tipos de perfil solicitados en pacientes hospitalizados en el Hospital Universitario de San Vicente Fundación. Métodos: estudio retrospectivo en pacientes mayores de 14 años, no gestantes, hospitalizados en el Hospital Universitario de San Vicente Fundación. Se evaluaron 351 registros en el sistema de historia clínica, se definieron seis grupos de pertinencia, las categorías 1 a 4 se consideraron como pertinente, y la 5 y 6 como solicitudes de pruebas no pertinentes. Se registraron variables demográficas y clínicas. Las variables estadísticas cuantitativas fueron evaluadas con la prueba U Mann-Whitney, las variables cualitativas con chi2 Pearson y Estadístico de Fisher. Resultados: se obtuvieron valores normales en 67% de las TSH medidas, en 80% de las T4 y el 53% de las T3. La anormalidad más frecuente de la TSH fue elevación en 24%, para la T4 libre fue su reducción en 11.5% y para la T3 elevación en 27%. Se encontró TSH ≤ 0.1 en 3.5% y ≥ 20 en 3.9%. De los 60 pacientes con TSH elevada el 75% están entre 5 y 9.99 mUI/mL. La T4L ≤ de 0.7 ng/dL fue 11.5% y ≥ 1.48 en 8.6%. El 95% de las T4L medidas en la categoría no pertinente fueron normales. Conclusiones: se debe mejorar la pertinencia de solicitud de pruebas tiroideas en hospitalización. Se propone abordaje inicial solo con TSH
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