Immunogenicity, effectiveness and safety of COVID-19 vaccine in older adults living in nursing homes: A real-life study / Inmunogenicidad, efectividad y seguridad de la vacuna COVID-19 en adultos mayores que viven en hogares geriátricos: un estudio de la vida real

Introduction: BNT162b2 (BioNTech and Pfizer) is a nucleoside-modified mRNA vaccine that provides protection against SARS-CoV-2 infection and is generally well tolerated. However, data about its efficacy, immunogenicity and safety in people of old age or with underlying chronic conditions are scarce. Purpose: To describe BNT162b2 (BioNTech and Pfizer) COVID-19 vaccine immunogenicity, effectiveness and reactogenicity after complete vaccination (two doses), and immunogenicity and reactogenicity after one booster, in elders residing in nursing homes (NH) and healthy NH workers in real-life conditions. Methods: Observational, ambispective, multicenter study. Older adults and health workers were recruited from three nursing homes of a private hospital corporation located in three Spanish cities. The primary vaccination was carried out between January and March 2021. The follow-up was 13 months. Humoral immunity, adverse events, SARS-CoV-2 infections, hospitalizations and deaths were evaluated. Cellular immunity was assessed in a participant subset. Results: A total of 181 residents (mean age 84.1 years; 89.9% females, Charlson index ≥2: 45%) and 148 members of staff (mean age 45.2 years; 70.2% females) were surveyed (n:329). After primary vaccination of 327 participants, vaccine response in both groups was similar; ≈70% of participants, regardless of the group, had an antibody titer above the cut-off considered currently protective (260BAU/ml). This proportion increased significantly to ≈ 98% after the booster (p<0.0001 in both groups). Immunogenicity was largely determined by a prior history of COVID-19 infection. Twenty residents and 3 workers were tested for cellular immunity. There was evidence of cellular immunity after primary vaccination and after booster. (AU)

Introducción: La vacuna BNT162b2 (BioNTech y Pfizer) es una vacuna de ARNm modificado con nucleósidos que proporcionó protección contra la infección por el SARS-CoV-2 y generalmente fue bien tolerada. Sin embargo, los datos sobre su efectividad y seguridad en personas de edad avanzada o con enfermedades crónicas subyacentes son escasos. Objetivo: Describir la inmunogenicidad, efectividad y seguridad de esta vacuna tras la vacunación completa (dos dosis), y la inmunogenicidad y reactogenicidad tras un refuerzo, en ancianos residentes en hogares geriátricos y trabajadores sanos de estos lugares en condiciones reales. Métodos: Estudio observacional, ambispectivo y multicéntrico. Se reclutaron ancianos y trabajadores sanitarios de tres hogares geriátricos de ancianos de un grupo hospitalario de entidad privada situados en tres ciudades españolas. La vacunación primaria se realizó entre enero y marzo de 2021. El seguimiento fue de 13 meses. Se evaluó la inmunidad humoral, los eventos adversos, las infecciones por SARS-CoV-2, las hospitalizaciones y las muertes. Se evaluó la inmunidad celular en un subconjunto de participantes. Resultados: Se registraron datos de 181 residentes (edad promedio 84,1 años; 89,9% mujeres, índice de Charlson ≥2: 45%) y 148 trabajadores (edad promedio 45,2 años; 70,2% mujeres) (n:329). Tras la primera dosis a 327 de los participantes, la respuesta a la vacuna en ambos grupos fue similar; ≈70% de los participantes, independientemente del grupo, tuvieron un título de anticuerpos por encima del corte considerado actualmente como protector (260 BAU/ml). Esta proporción aumentó significativamente a ≈ 98% después del refuerzo (p<0,0001 en ambos grupos). La inmunogenicidad se determinó en gran medida por los antecedentes de infección por COVID-19. Se analizó la inmunidad celular de 20 residentes y 3 trabajadores. Hubo evidencia de inmunidad celular después de la vacunación primaria y después del refuerzo. (AU)

Immunogenicity, effectiveness and safety of COVID-19 vaccine in older adults living in nursing homes: A real-life study.

INTRODUCTION: BNT162b2 (BioNTech and Pfizer) is a nucleoside-modified mRNA vaccine that provides protection against SARS-CoV-2 infection and is generally well tolerated. However, data about its efficacy, immunogenicity and safety in people of old age or with underlying chronic conditions are scarce. PURPOSE: To describe BNT162b2 (BioNTech and Pfizer) COVID-19 vaccine immunogenicity, effectiveness and reactogenicity after complete vaccination (two doses), and immunogenicity and reactogenicity after one booster, in elders residing in nursing homes (NH) and healthy NH workers in real-life conditions. METHODS: Observational, ambispective, multicenter study. Older adults and health workers were recruited from three nursing homes of a private hospital corporation located in three Spanish cities. The primary vaccination was carried out between January and March 2021. The follow-up was 13 months. Humoral immunity, adverse events, SARS-CoV-2 infections, hospitalizations and deaths were evaluated. Cellular immunity was assessed in a participant subset. RESULTS: A total of 181 residents (mean age 84.1 years; 89.9% females, Charlson index ≥2: 45%) and 148 members of staff (mean age 45.2 years; 70.2% females) were surveyed (n:329). After primary vaccination of 327 participants, vaccine response in both groups was similar; ≈70% of participants, regardless of the group, had an antibody titer above the cut-off considered currently protective (260BAU/ml). This proportion increased significantly to ≈ 98% after the booster (p<0.0001 in both groups). Immunogenicity was largely determined by a prior history of COVID-19 infection. Twenty residents and 3 workers were tested for cellular immunity. There was evidence of cellular immunity after primary vaccination and after booster. During the study, one resident was hospitalized for SARS-CoV-2. No SARS-CoV-2-related deaths were reported and most adverse events were mild. CONCLUSIONS: Our results suggest that the BNT162b2 mRNA COVID-19 vaccine is immunogenic, effective and safe in elderly NH residents with underlying chronic conditions.

Evaluación del índice de riesgo del primer trimestre en casos de embarazo múltiple con presencia de un feto perdido / Evaluation of the risk index of the first-trimester combined screening test in cases of multiple pregnancy with a «vanishing twin»

Fundamento y objetivo. Justificar una evaluación correcta del test combinado de cribado prenatal del primer trimestre, en casos especiales de embarazos gemelares con pérdida de uno de los embriones, debido al aumento de estos casos, sobre todo en gestantes sometidas a técnicas de reproducción in vitro. Paciente y métodos. Se documenta un caso clínico de gestación gemelar bicorial biamniótica con pérdida del primer feto en la semana 12. Se le solicita cribado prenatal en el que la estimación del índice de riesgo del primer trimestre no se pudo valorar como tal. Discusión y conclusiones. El índice de riesgo no es calculable debido a la pérdida de uno de los fetos. Los niveles de la fracción libre de la subunidad beta de la gonadotropina coriónica humana (Beta-hCG) en suero no se ven afectados pero sí se produce un aumento significativo de los niveles de la proteína plasmática A asociada al embarazo (PAPP-A), que depende del tiempo transcurrido desde la pérdida fetal, por lo que no puede considerarse ni como un feto aislado ni como 2. Por tanto, para evaluar el riesgo se recomienda una estimación de la translucencia nucal fetal (TN) y la Beta-hCG libre, o únicamente la TN, atendiendo también a unos múltiplos de la mediana (MoM) dentro de la normalidad(AU)

Background and purpose. To justify an accurate assessment of the first-trimester combined screening test, in special cases of twin pregnancies with a vanishing twin; because the increase in such cases specially is being seen in pregnant women undergoing in vitro fertilization techniques. Patients and methods. We report a case of biamniotic bichorionic twin pregnancy with loss of the first fetus at week 12. Prenatal screening was asked in wich it couldn’t been estimated the risk index for the first trimester screening test. Discussion and conclusions. The risk index is not calculable due to the loss of one fetus. The levels of the free fraction of the beta subunit of human chorionic gonadotropin (Beta-hCG) in serum are not affected but there is a significant increase in the levels of pregnancy associated plasma protein-A (PAPP-A), which depends on the time since fetal loss; so the serum levels cannot be regarded neither as an isolated fetus or as 2. Therefore to assess the risk of the first-trimester combined screening test, it is recommended to estimate the fetal nuchal translucency thickness (NT) and Beta-hCG, or just only NT, also considering the median multiples (MoM) within the normal limits(AU)