Ethical considerations in post-market-approval monitoring and regulation of vaccines

Thompson, Alison; Komparic, Ana; Smith, Maxwell J.

doi:10.1016/j.vaccine.2014.10.016

Cited by 9 publications

(6 citation statements)

References 22 publications

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“…The interests of the public are protected by regulators such as the US FDA, whose role is to approve vaccines only if the proven benefits outweigh any measurable risks [ 147 ]. Assessment of risk–benefit is more complex for vaccines than for therapeutic interventions, as the benefits of vaccination can accrue to the population through herd immunity, while the risks of any adverse reactions are suffered by individuals, potentially raising complex ethical issues [ 148 ]. Hence, perceptions of risk–benefit at the individual level—i.e.…”

Section: Consumer Perceptions Of Adjuvant Safetymentioning

confidence: 99%

Comparative Safety of Vaccine Adjuvants: A Summary of Current Evidence and Future Needs

2015

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Improved use of highly pure antigens to improve vaccine safety has led to reduced vaccine immunogenicity and efficacy. This has led to the need to use adjuvants to improve vaccine immunogenicity. The ideal adjuvant should maximize vaccine immunogenicity without compromising tolerability or safety or posing undue risk. Unfortunately, adjuvant research has lagged behind other vaccine areas such as antigen discovery, with the consequence that only a very limited number of adjuvants based on aluminum salts, monophosphoryl lipid A and oil emulsions are currently approved for human use. Recent strategic initiatives to support adjuvant development by the National Institutes of Health should translate into greater adjuvant choices in the future. Mechanistic studies have been valuable in better understanding adjuvant action but mechanisms of adjuvant toxicity are less well understood. The inflammatory or danger-signal model of adjuvant action implies that increased vaccine reactogenicity is the inevitable price for improved immunogenicity. Hence, adjuvant reactogenicity may be avoidable only if it is possible to separate inflammation from adjuvant action. The biggest remaining challenge in the adjuvant field is to decipher the potential relationship between adjuvants and rare vaccine adverse reactions such as narcolepsy, macrophagic myofasciitis or Alzheimer’s disease. While existing adjuvants based on aluminum salts have a strong safety record, there is an ongoing need for new adjuvants and for more intensive research into adjuvants and their effects.

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Section: Consumer Perceptions Of Adjuvant Safetymentioning

confidence: 99%

Comparative Safety of Vaccine Adjuvants: A Summary of Current Evidence and Future Needs

2015

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“…Fuente: elaboración propia a partir de Field y Caplan (2012), Thompson et al (2014) y Verweij (2017.…”

Section: Riesgosunclassified

«Vísteme despacio que tengo prisa». Un análisis ético de la vacuna contra la COVID-19: fabricación, distribución y reticencia

Cruz-Piqueras

Hortal-Carmona

Bernáldez³

2020

enrahonar

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La llegada de una vacuna frente al SARS-CoV-2 que pueda frenar la expansión de la infección se ha postulado como la respuesta definitiva para frenar la pandemia de COVID-19. Lejos de ser una solución libre de conflictos éticos, la introducción de una nueva vacuna en la práctica de la salud pública, y que se haga en una situación de inestabilidad social, política y económica, vuelve a activar la línea de tensión entre el poder de las instituciones, la autonomía de las personas y las dinámicas de los mercados globales. Esto hace que sea preciso un análisis ético que incluya los conflictos en el ámbito de la investigación y el desarrollo de la vacuna, los elementos de justicia global presentes en la distribución de la vacuna, las decisiones de priorización cuando la oferta de esta no cubra la demanda existente y las posturas que se deberán tomar, desde los poderes públicos, para abordar los casos de reticencia por parte de las personas que no deseen que se les administre la vacuna -o que planteen dudas ante ello-. Palabras clave: ética de la salud pública; vacunación; reticencia; ética de la investigación; justicia; criterios distribución; COVID-19 Abstract. "Haste makes waste". An ethical analysis of the COVID-19 vaccine: Development, allocation and hesitationThe development of a vaccine against SARS-CoV-2 that can stop the spread of the infection has been postulated as the definitive response to end the COVID-19 pandemic. Far from being free of ethical conflicts, the introduction of a new vaccine in a situation of social, political and economic instability reactivates the tension among institutional power, people's autonomy and the dynamics of global markets. This requires an ethical analysis that includes conflicts in the field of vaccine research and development, glob-

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“…Such a choice may be premature, however, given the limited and selective efficacy of CYD-TDV and the lingering uncertainty regarding its safety. In vaccine development, the relevant regulatory authorities must have access to all evidence that allows the potential adverse effects of a vaccine candidate to be evaluated and weighed carefully against the potential benefits 30 . Local and global capacity for assessing the long-term safety of CYD-TDV in post-licensing surveillance must be strengthened to meet the challenges imposed by the vaccine’s complex performance.…”

Section: Global Consequencesmentioning

confidence: 99%

Dengue vaccine: local decisions, global consequences

López‐Gatell

Alpuche-Aranda

Santos-Preciado

et al. 2016

Bull. World Health Organ.

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As new vaccines against diseases that are prevalent in low- and middle-income countries gradually become available, national health authorities are presented with new regulatory and policy challenges. The use of CYD-TDV – a chimeric tetravalent, live-attenuated dengue vaccine – was recently approved in five countries. Although promising for public health, this vaccine has only partial and heterogeneous efficacy and may have substantial adverse effects. In trials, children who were aged 2–5 years when first given CYD-TDV were seven times more likely to be hospitalized for dengue, in the third year post-vaccination, than their counterparts in the control group. As it has not been clarified whether this adverse effect is only a function of age or is determined by dengue serostatus, doubts have been cast over the long-term safety of this vaccine in seronegative individuals of any age. Any deployment of the vaccine, which should be very cautious and only considered after a rigorous evaluation of the vaccine’s risk–benefit ratio in explicit national and subnational scenarios, needs to be followed by a long-term assessment of the vaccine’s effects. Furthermore, any implementation of dengue vaccines must not weaken the political and financial support of preventive measures that can simultaneously limit the impacts of dengue and several other mosquito-borne pathogens.

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Ethical considerations in post-market-approval monitoring and regulation of vaccines

Cited by 9 publications

References 22 publications

Comparative Safety of Vaccine Adjuvants: A Summary of Current Evidence and Future Needs

Comparative Safety of Vaccine Adjuvants: A Summary of Current Evidence and Future Needs

«Vísteme despacio que tengo prisa». Un análisis ético de la vacuna contra la COVID-19: fabricación, distribución y reticencia

Dengue vaccine: local decisions, global consequences

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