Safety, Effectiveness, and Immunogenicity 6 Months After BNT162B2 mRNA Vaccine in Frail Nursing Home Residents

Abstract

Background 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. Objectives 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. Design This was an ambispective observational study. Setting Residents of a long-term care facility in Madrid, Spain. Participants 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. Measurements 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). Results 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. Conclusion 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.

Multiple sclerosis-disease modifying therapies affect humoral and T-cell response to mRNA COVID-19 vaccine

“…Among them, the mRNA vaccine mRNABNT162b2 (Comirnaty ® ) has been widely employed in the Italian population ( 4 ). Several studies showed that mRNA vaccines help protect from severe COVID-19 disease, hospitalization and death in immunocompetent individuals and in frail populations ( 5 , 6 ). However, multiple sclerosis (MS) disease modifying therapies (DMTs) might affect COVID-19 disease severity as well as the development of humoral and cellular immunity after SARS-CoV-2 exposure or vaccination ( 7 , 8 ).…”

The EURO-FORTA (Fit fOR The Aged) List Version 2: Consensus Validation of a Clinical Tool for Improved Pharmacotherapy in Older Adults

“…For instance, the evidence for the evaluation of SGLT2 inhibitors for the treatment of heart failure originates from large RCTs including many older adults, in which the overall benefit of using dapagliflozin [ 31 ] or empagliflozin [ 29 ] in older patients with heart failure was shown, and the strength of these trials can be considered as Level B [ 30 ] (or level B-R [ 36 ]). Nevertheless, due to the exclusion of older people (especially the frail elderly and residents of long-term care facilities [ 37 ]) from clinical trials, the strength of the evidence for other medications included in the FORTA lists is still widely based on consensus of the participating experts and/or small studies, retrospective studies, or registries. Future RCTs and meta-analyses are still urgently needed to improve the level (quality) of evidence and the related assessments for a large number of substances.…”

Headaches during/after SARS‐CoV‐2 infection/vaccination can be primary and secondary as well as acute and chronic

“…In a study of 114 patients with long COVID syndrome, 22.6% reported persistent headaches [3]. Likewise, 7.3% of 137 frail nursing home residents reported headaches 6 months after primary vaccination [4]. Headaches in long COVID and PACVS may have a different character, treatment need and response, and outcome than headaches in acute SC2I or ACVS.…”