Ethical considerations on placebo-controlled vaccine trials in pregnant women
Bibliographic Data
| ID | 15693221 |
|---|---|
| Authors | Ana Cecilia Amado Xavier De Oliveira (0000-0002-5798-2258, Fundação Oswaldo Cruz, corresponding author), Francisco J R Paumgartten (0000-0002-6207-0149, Fundação Oswaldo Cruz) |
| Year | 2023 |
| Volume | 31 |
| Publication date | 2023-01-01 |
| Peer Reviewed | Yes |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Revista Bioética (JOURNAL) |
| Journal identifiers | ISSN: 1983-8034 • E-ISSN: 1983-8042 |
| Publisher | FapUNIFESP (SciELO) (PUBLISHER) |
| DOI | 10.1590/1983-803420233205pt |
| OpenAlex | W4382315895 |
| Language | EN |
| References cited | 31 |
Placebo use in clinical trials, whenever a proven effective treatment exists, is one of the most debated topics in contemporary research ethics. This article addresses the ethical framework for placebo use in clinical trials assessing vaccine efficacy in pregnant women. Vaccine trial participants are healthy at the outset and some must be infected during the study to demonstrate the product’s efficacy, meaning that placebo-treated participants are under risk of serious and irreversible harm. If effective vaccines exist, such risk precludes placebo use. This interdiction should be extended to any clinical trial of vaccine efficacy in pregnant women, because a demonstration of clinical efficacy in nonpregnant individuals and comparable immunogenic responses in pregnant women are predictors of efficacy in pregnancy as well. Moreover, product effectiveness in real-world use scenarios can be ascertained by observational studies conducted after its inclusion in vaccination campaigns
Alternative medicine · Clinical trial · Family medicine · Harm · Intensive care medicine · Meaning (existential · Observational study · Pathology · Placebo · Pregnancy · Psychotherapist · Vaccination · Vaccine efficacy · COVID-19 Impact on Reproduction · Ethics and Legal Issues in Pediatric Healthcare · Medicine · Psychology · Social Psychology · Vaccine Coverage and Hesitancy · Immunology · Internal Medicine
Unfair inequalities in health and health care
Equipoise and the Ethics of Clinical Research
Principles of Clinical Ethics and Their Application to Practice
Can context justify an ethical double standard for clinical research in developing countries
Enrolling Pregnant Women
Ethical issues in placebo-controlled trials of Covid-19 vaccines
Human Rights Begin at Birth
| Citation velocity | historical |
|---|---|
| Highly cited | No |