Evidence map›Paper›PMID 33922415›Full record

ArticleVaccines2021

Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective.

Davide Ferorelli, Lorenzo Spagnolo, Maricla Marrone, Serena Corradi, Maria Silvestre, Federica Misceo, Francesco Paolo Bianchi, Pasquale Stefanizzi, Biagio Solarino, Alessandro Dell'Erba and 1 more

Abstract read
In one paragraph

Article in Vaccines, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
  2. Article
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.

Davide FerorelliSection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy.ORCID 0000-0001-8150-7476
Lorenzo SpagnoloSection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy.
Maricla MarroneSection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy.
Serena CorradiSection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy.
Maria SilvestreSection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy.
Federica MisceoSection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy.ORCID 0000-0001-8956-8230
Francesco Paolo BianchiDepartment of Biomedical Sciences and Human Oncology, Aldo Moro University of Bari, 70121 Bari, Italy.ORCID 0000-0002-9659-0193
Pasquale StefanizziDepartment of Biomedical Sciences and Human Oncology, Aldo Moro University of Bari, 70121 Bari, Italy.
Biagio SolarinoSection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy.
Alessandro Dell'ErbaSection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy.
Silvio TafuriDepartment of Biomedical Sciences and Human Oncology, Aldo Moro University of Bari, 70121 Bari, Italy.ORCID 0000-0003-4194-0210

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

During the COVID-19 outbreak, the lack of official recommendations on the treatment has led healthcare workers to use multiple drugs not specifically tested and approved for the new insidious disease. After the availability of the first COVID-19 vaccines (Comirnaty Pfizer-BioNTech and Moderna COVID19 vaccine), an authorization was issued by national and international Drug Regulatory Agencies in order to speed up their introduction on the market and their administration on a large scale. Despite the authorization, the off-label use of these vaccines may still be possible especially to answer specific concerns as the lack of vaccine doses, the delay in the delivery of planned doses or the pressure from public opinion and political influence also in relation to the evolution of the pandemic. This paper aims to assess the possible off-label use of COVID-19 vaccines and the ethical and medico-legal implications of this eventuality. The scope of this paper is to point out the possible consequences of off-label use of COVID-19 vaccines and possible mitigation and preventive measures to be taken by healthcare workers involved in vaccination procedures.

Indexed as

COVID-19ethicsforensic sciencesoff-label usepublic healthsafety of vaccinesSARS-CoV-2vaccinevaccine strategies

Identifiers

PMID33922415
PMCPMC8146018

What OpenQuestion holds

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LicenceCC BY
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.