Loading...
Publication
Gestão de risco nas vacinas Anti-COVID-19
| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| 859.52 KB | Adobe PDF |
Authors
Abstract(s)
A 11 de março de 2020 a Organização Mundial da Saúde declarou como pandemia a doença causada pelo coronavírus 2 da Síndrome Respiratória Aguda Grave. A doença rapidamente se alastrou pelo mundo com graves impactos na saúde pública, sociedade e economia, surgindo assim a necessidade de desenvolver uma vacina segura e eficaz.
Em circunstâncias normais, para o desenvolvimento de uma vacina são necessários entre 10 e 15 anos, sendo que a respetiva aprovação apenas é alcançada após conclusão dos estudos conducentes à fase III dos ensaios clínicos. No entanto, considerando a situação emergente da Doença do Coronavírus 19 (COVID-19), o processo foi acelerado, assistindo-se ao desenrolar em paralelo de diversas etapas de modo a garantir o eficiente desenvolvimento de vacinas, respeitando igualmente os princípios de qualidade, segurança e eficácia. Assim, todo o processo de desenvolvimento das primeiras vacinas anti-COVID-19 demorou entre 12 e 18 meses, conferindo aos respetivos titulares uma autorização condicional de introdução no mercado com alta vigilância relativamente à sua eficácia e perfil de segurança pós-autorização.
As vacinas podem ser desenvolvidas tendo por base diversas técnicas, sendo sempre necessário adequar ao microrganismo em questão e ter em conta os diversos fatores intrínsecos associados à manipulação, armazenamento e transporte. As vacinas Comirnaty®, Spikevax®, Vaxzevria®, JCOVDEN®, Nuvaxovid® e Valneva® que foram aprovadas pela Agência Europeia do Medicamento para uso excecional na União Europeia são à base de ácidos ribonucleicos mensageiros, vetores virais, subunidades proteicas e vírus inativado.
Todas as vacinas autorizadas na União Europeia são submetidas a um processo de vigilância de acordo com planos de gestão de risco especificamente delineados para o efeito. Estes têm como principal objetivo identificar, caracterizar, prevenir ou minimizar os riscos que possam estar associados à utilização. Deste modo, juntamente com as entidades competentes é garantida a segurança e a efetividade das vacinas.
On March 11th of 2020 the World Health Organization declared the disease caused by the Severe Acute Respiratory Syndrome coronavirus 2 a pandemic. The disease has rapidly spread around the world with severe impacts on public health, society and economy, resulting in the need to develop a safe and effective vaccine. In normal circumstances, it takes 10 to 15 years to develop a vaccine, and approval is only achieved after completion of studies, leading to phase III clinical trials. However, considering the emerging situation of Coronavirus 19 Disease (COVID-19), the process was accelerated, with several steps being carried out in parallel to ensure efficient vaccine development while respecting the principles of quality, safety and efficacy. Therefore, the entire development process of the first anti-COVID-19 vaccines took between 12 and 18 months, giving their owners a conditional marketing authorization with high vigilance regarding their effectiveness and post-authorization safety profile. Vaccines can be developed using various techniques, and always need to be tailored to the microorganism in question and take into account the various intrinsic factors associated with handling, storage and transport. The Comirnaty®, Spikevax®, Vaxzevria®, JCOVDEN®, Nuvaxovid® and Valneva® vaccines that have been approved by the European Medicines Agency for exceptional use in the European Union are based on messenger ribonucleic acids, viral vectors, protein subunits and inactivated virus. All vaccines authorized in the European Union are subject to a surveillance process according to specifically designed risk management plans for the effect. The main objective of these plans is to identify, characterize, prevent or minimize the risks that may be associated with their use. In this way, together with the competent authorities, the safety and effectiveness of the vaccines is guaranteed.
On March 11th of 2020 the World Health Organization declared the disease caused by the Severe Acute Respiratory Syndrome coronavirus 2 a pandemic. The disease has rapidly spread around the world with severe impacts on public health, society and economy, resulting in the need to develop a safe and effective vaccine. In normal circumstances, it takes 10 to 15 years to develop a vaccine, and approval is only achieved after completion of studies, leading to phase III clinical trials. However, considering the emerging situation of Coronavirus 19 Disease (COVID-19), the process was accelerated, with several steps being carried out in parallel to ensure efficient vaccine development while respecting the principles of quality, safety and efficacy. Therefore, the entire development process of the first anti-COVID-19 vaccines took between 12 and 18 months, giving their owners a conditional marketing authorization with high vigilance regarding their effectiveness and post-authorization safety profile. Vaccines can be developed using various techniques, and always need to be tailored to the microorganism in question and take into account the various intrinsic factors associated with handling, storage and transport. The Comirnaty®, Spikevax®, Vaxzevria®, JCOVDEN®, Nuvaxovid® and Valneva® vaccines that have been approved by the European Medicines Agency for exceptional use in the European Union are based on messenger ribonucleic acids, viral vectors, protein subunits and inactivated virus. All vaccines authorized in the European Union are subject to a surveillance process according to specifically designed risk management plans for the effect. The main objective of these plans is to identify, characterize, prevent or minimize the risks that may be associated with their use. In this way, together with the competent authorities, the safety and effectiveness of the vaccines is guaranteed.
Description
Keywords
Eficácia Farmacovigilância Plano de gestão de risco Segurança Vacinas anti-COVID-19