Ethical issues in placebo-controlled trials of COVID-19 vaccines

Oliveira, Ana Raquel Soares de; Paumgartten, Francisco José Roma

doi:10.1590/0102-311x00007221

Cited by 6 publications

(9 citation statements)

References 6 publications

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“…Since there is still limited knowledge about COVID-19 and the effects of experimental treatments, the risks of using a placebo as a treatment comparator are still high. Thus, similar to COVID-19 vaccine trials wherein "core ethical values strongly recommend that participants who had received placebo in COVID-19 vaccine trials should be promptly vaccinated after an interim analysis had proven that the vaccines are efficacious" [ 207 ], one could postulate that participants who were under the placebo arm (who often are representatives of a high-risk group of severe disease) should be given the COVID-19 oral antiviral treatment as soon as it was proven to be effective. However, this is virtually impossible since oral antivirals need to be given early after SARS-CoV-2 infection.…”

Section: Ethical Issues In Clinical Trials Of Oral Antivirals In Covi...mentioning

confidence: 99%

Oral antiviral treatments for COVID-19: opportunities and challenges

Rahmah

Arero²,

Jibril³

et al. 2022

Pharmacol. Rep

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The use of antiviral COVID-19 medications can successfully inhibit SARS-CoV-2 replication and prevent disease progression to a more severe form. However, the timing of antiviral treatment plays a crucial role in this regard. Oral antiviral drugs provide an opportunity to manage SARS-CoV-2 infection without a need for hospital admission, easing the general burden that COVID-19 can have on the healthcare system. This review paper (i) presents the potential pharmaceutical antiviral targets, including various host-based targets and viral-based targets, (ii) characterizes the first-generation anti-SARS-CoV-2 oral drugs (nirmatrelvir/ritonavir and molnupiravir), (iii) summarizes the clinical progress of other oral antivirals for use in COVID-19, (iv) discusses ethical issues in such clinical trials and (v) presents challenges associated with the use of oral antivirals in clinical practice. Oral COVID-19 antivirals represent a part of the strategy to adapt to long-term co-existence with SARS-CoV-2 in a manner that prevents healthcare from being overwhelmed. It is pivotal to ensure equal and fair global access to the currently available oral antivirals and those authorized in the future.

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Section: Ethical Issues In Clinical Trials Of Oral Antivirals In Covi...mentioning

confidence: 99%

Oral antiviral treatments for COVID-19: opportunities and challenges

Rahmah

Arero²,

Jibril³

et al. 2022

Pharmacol. Rep

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“…These (and undoubtedly other) issues can be identified under the following headings: mandating vaccination; triage, including ICU triage; justice; placebo-controlled trials of COVID-19 vaccines; clinical trials; health management, including honesty, trust, accountability and transparency; balancing the interests of patients and the entire community in relation to stay-at-home orders and social distancing requirements; the risks and anxiety levels experienced by healthcare workers related to heavy workloads, stress, risk of contracting infectious diseases, etc. [67][68][69][70][71][72][73][74].…”

Section: Ethicsmentioning

confidence: 99%

The COVID-19 Pandemic Response and Its Impact on Post-Corona Health Emergency and Disaster Risk Management in Türkiye

Erbay

2024

Sustainability

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The COVID-19 pandemic, which has affected the entire world, has not only created a number of emerging issues for each country, especially in the field of public health, but has also provided a number of opportunities for risk management, alternative strategies and completely new ways of looking at challenges. This brief report examines the COVID-19 pandemic response in Türkiye and the possible implications of the experience for future responses to other health emergencies and disaster risk management, based on the lessons learned. This study uses publicly available literature from government, private sector and academic sources to analyse the conflicts, changes and lessons learned during the COVID-19 pandemic, which are components of the World Health Organization (WHO) Health Emergency and Disaster Risk Management (Health EDRM) framework. The COVID-19 experience in Türkiye has several aspects, including the significant role of healthcare workers, the existence of an effective health system accustomed to emergencies, applications based on information technologies, the partial transparency of public authorities in providing information and a socio-cultural environment related to cooperation on prevention strategies, including wearing masks and vaccination. Challenges in Türkiye include distance learning in schools, lockdowns that particularly affect the elderly, ensuring environmental sustainability, hesitation about the effectiveness of social/financial support programs, the socio-cultural trivialisation of pandemics after a while and the relaxation of prevention strategies. Lessons learned from the COVID-19 pandemic include the value of transparency in public health/healthcare information, the strengthening of all aspects of the health system in terms of health workers and the importance of a balanced economy prepared for foreseeable risks.

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“…Portanto, para testar se uma vacina é eficaz, de modo que a hipótese nula possa ser rejeitada ou não por uma análise estatística robusta, é necessário estimar antecipadamente um número alvo (mínimo) de indivíduos, entre os selecionados para o estudo, que devem ser diagnosticados com a doença contagiosa a ser prevenida antes que o código de cegamento seja quebrado para uma avaliação preliminar (ou final) dos resultados do estudo. Isso está detalhado nas recomendações da Organização Mundial da Saúde para estudos clínicos de eficácia de vacinas 36,37 .…”

Section: Avaliações Da Eficácia De Intervenções Profiláticas E Terapê...unclassified

“…Se um ECR anterior demonstrou a eficácia de outras vacinas para a infecção sendo investigada, estudos adicionais sobre produtos imunizantes para a mesma doença contagiosa devem sempre usar comparadores ativos em vez de inativos 37 . Isso se aplica a qualquer estudo de eficácia de vacina envolvendo homens e/ou mulheres, gestantes ou não.…”

Section: Avaliações Da Eficácia De Intervenções Profiláticas E Terapê...unclassified

Considerações éticas sobre estudos de vacina controlada com placebo em gestantes

Paumgartten

De-Oliveira

2023

Rev. Bioét.

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Resumo O uso de placebo em ensaios clínicos, quando um tratamento comprovadamente eficaz existe, é um dos principais tópicos debatidos na ética em pesquisa contemporânea. Este artigo aborda o quadro ético para o uso de placebo em ensaios clínicos que avaliam a eficácia de vacina em gestantes. Participantes em ensaios de vacina são saudáveis no início e alguns devem ser inoculados durante o estudo para demonstrar a eficácia do produto. Ou seja, participantes tratados com placebo estão sob risco de danos graves e irreversíveis. Se existirem vacinas eficazes, esse risco impede o uso de placebo. Essa interdição deve ser estendida a qualquer ensaio clínico de eficácia de vacina em gestantes, pois a demonstração de eficácia clínica em não gestantes e as respostas imunogênicas comparáveis em gestantes também são preditoras de eficácia na gravidez. Ademais, a eficácia do produto em cenários reais de uso pode ser verificada por estudos observacionais realizados após sua inclusão em campanhas de vacinação.

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Ethical issues in placebo-controlled trials of COVID-19 vaccines

Cited by 6 publications

References 6 publications

Oral antiviral treatments for COVID-19: opportunities and challenges

Oral antiviral treatments for COVID-19: opportunities and challenges

The COVID-19 Pandemic Response and Its Impact on Post-Corona Health Emergency and Disaster Risk Management in Türkiye

Considerações éticas sobre estudos de vacina controlada com placebo em gestantes

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