Evidence map›Paper›PMID 35794430›Full record

Observational studyDrugs & aging2022

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

Pablo Montejano-Hervás, Javier Gómez-Pavón, Olga Tornero-Torres, Mª Victoria Valverde-Moyar, Beatriz Martín Cruz, Maribel Vela Carbonera, Raquel Fuentes-Irigoyen, Pilar Tejada González, Margarita González-Becerra, Esther Higueras Sánchez and 1 more

Open access · bronzeAbstract readObservational Study
In one paragraph

Observational study in Drugs & aging, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Pablo Montejano-HervásDepartment of Pharmacy, Hospital Central de la Cruz Roja "San José y Santa Adela", Madrid, Spain. pablo.montejano@salud.madrid.org.ORCID 0000-0003-2383-1213
Javier Gómez-PavónDepartment of Geriatrics, Hospital Central de la Cruz Roja "San José y Santa Adela", University of Medicine, Alfonso X el Sabio, Madrid, Spain.
Olga Tornero-TorresDepartment of Pharmacy, Hospital Central de la Cruz Roja "San José y Santa Adela", Madrid, Spain.
Mª Victoria Valverde-MoyarResidencia de Personas Mayores Dr. Gastón Baquero, Comunidad de Madrid, Madrid, Spain.
Beatriz Martín CruzResidencia de Personas Mayores Dr. Gastón Baquero, Comunidad de Madrid, Madrid, Spain.
Maribel Vela CarboneraResidencia de Personas Mayores Dr. Gastón Baquero, Comunidad de Madrid, Madrid, Spain.
Raquel Fuentes-IrigoyenDepartment of Pharmacy, Hospital Central de la Cruz Roja "San José y Santa Adela", Madrid, Spain.
Pilar Tejada GonzálezDepartment of Pharmacy, Hospital Central de la Cruz Roja "San José y Santa Adela", Madrid, Spain.
Margarita González-BecerraDepartment of Geriatrics, Hospital Central de la Cruz Roja "San José y Santa Adela", University of Medicine, Alfonso X el Sabio, Madrid, Spain.
Esther Higueras SánchezResidencia de Personas Mayores Dr. Gastón Baquero, Comunidad de Madrid, Madrid, Spain.
Primitivo Ramos CorderoAgencia Madrileña de Atención Social, Comunidad de Madrid, Madrid, Spain.
Hospital Central de la Cruz Roja San José y Santa Adela · ESComunidad de Madrid · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundElderly 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.

objectivesThe 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.

designThis was an ambispective observational study.

settingResidents of a long-term care facility in Madrid, Spain.

participantsOne 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).

resultsSafety: 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.

conclusionThe 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.

Indexed as

COVID-19FrailtyAgedAged, 80 and overBNT162 VaccineFemaleFrail ElderlyHumansMalemRNA VaccinesNursing HomesSARS-CoV-2Vaccines, SyntheticBNT162 VaccinemRNA VaccinesVaccines, Synthetic

Identifiers

PMID35794430
PMCPMC9261238
OpenAlexW4284881750

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.