Department of Pharmacy, Hospital Central de la Cruz Roja "San José y Santa Adela", Madrid, Spain.
Department of Geriatrics, Hospital Central de la Cruz Roja "San José y Santa Adela", University of Medicine, Alfonso X el Sabio, Madrid, Spain.
Drugs Aging. 2022 Jul;39(7):587-595. doi: 10.1007/s40266-022-00959-6. Epub 2022 Jul 7.
Elderly people who reside in long-term care facilities form a frail and vulnerable population, with multiple pathologies and high percentages of cognitive and functional disability.
The aims of this study were to assess the safety of vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in frail nursing home residents and to evaluate its effectiveness 6 months after full vaccination.
This was an ambispective observational study.
Residents of a long-term care facility in Madrid, Spain.
One hundred and thirty-seven nursing home residents (81.8% female, mean age 87.77 ± 8.31 years) with high comorbidity (61.3% Charlson Index ≥ 3) and frailty (75% Clinical Frail Scale ≥ 7) who received the BNT162B2 mRNA vaccine.
Safety data were collected to evaluate the type of adverse drug reactions and their duration, severity, and causality. Immunogenicity was tested 6 months after the primary vaccination and effectiveness was evaluated by the incidence of SARS-CoV-2 infection, the number of hospital admissions, and mortality due to coronavirus disease 2019 (COVID-19).
Safety: Of the residents, 21.9% had some adverse reaction and 5.8% had a severe or more serious adverse reaction. The most frequent adverse reactions were fatigue (13.1%), pyrexia (12.4%), and headache (7.3%). No association was observed between frailty (including a need for palliative care) and clinical, functional or cognitive status of the participants and the occurrence of adverse events. Immunogenicity and Effectiveness: After 6 months of vaccination, only one case of SARS-CoV-2 infection was confirmed in the vaccinated residents. Most of the nursing home residents presented positive serology (95.2%). Loss of immunogenicity was associated with older age (95.12 ± 3.97 vs. 87.24 ± 8.25 years; p = 0.03) and no previous COVID-19 infection (16.6% vs. 70%; p < 0.001). Binary logistic regression models did not reveal this association.
The BNT162B2 vaccine is well tolerated and effective in nursing home residents, independently of their clinical, functional, cognitive, or frailty characteristics. For the most part, immunogenicity has been maintained over time, regardless of comorbidity, functional status or frailty.
居住在长期护理机构的老年人是一个脆弱的群体，他们患有多种疾病，认知和功能障碍的比例较高。
本研究旨在评估脆弱的养老院居民接种严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）疫苗的安全性，并评估其接种后 6 个月的有效性。
这是一项前瞻性观察研究。
西班牙马德里的一家长期护理机构。
137 名养老院居民（81.8%为女性，平均年龄 87.77±8.31 岁），共病率高（61.3%Charlson 指数≥3），虚弱（75%临床虚弱量表≥7），接种 BNT162B2 mRNA 疫苗。
收集安全性数据以评估药物不良反应的类型及其持续时间、严重程度和因果关系。在初次接种后 6 个月检测免疫原性，并通过 SARS-CoV-2 感染的发生率、住院人数和因 2019 年冠状病毒病（COVID-19）导致的死亡率来评估有效性。
安全性：21.9%的居民出现了一些不良反应，5.8%的居民出现了严重或更严重的不良反应。最常见的不良反应是疲劳（13.1%）、发热（12.4%）和头痛（7.3%）。虚弱（包括姑息治疗需求）与参与者的临床、功能或认知状态以及不良事件的发生之间未观察到相关性。免疫原性和有效性：接种疫苗 6 个月后，仅在接种疫苗的居民中确诊了 1 例 SARS-CoV-2 感染病例。大多数养老院居民的血清学检测呈阳性（95.2%）。免疫原性丧失与年龄较大（95.12±3.97 岁与 87.24±8.25 岁；p=0.03）和无既往 COVID-19 感染（16.6%与 70%；p<0.001）有关。二元逻辑回归模型未显示这种关联。
BNT162B2 疫苗在养老院居民中耐受性良好且有效，与他们的临床、功能、认知或虚弱特征无关。在很大程度上，免疫原性随时间保持，与共病、功能状态或虚弱无关。
