On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties
Autor(a) principal: | |
---|---|
Data de Publicação: | 2021 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | eng por |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1881 |
Resumo: | Introduction: The COVID-19 vaccines in use (inactivaded virus, encapsulated m-RNA, non-replicating adenovirus-vectored DNA) were clinically tested in randomized placebocontrolled phase-3 studies. Objective: To address certainties and uncertainties about safety and effectiveness of COVID-19 vaccines that were approved for use in various countries. Method: The evidence provided by clinical studies on the efficacy and safety of COVID-19 vaccines was critically appraised. Results: COVID-19 vaccines proved to be efficacious and safe in clinical trials. Adverse events were mostly those of minor severity commonly noted with other vaccines such as injection site pain, mild flu-like symptoms, headache and asthenia. Although being very rare, anaphylaxis-like reactions were noted with mRNA vaccines. Uncertainties regarding vaccine effectiveness refer mainly to the (long-term) duration of immunity provided by vaccination, the degree of protection conferred to elderly people, and how effective vaccines are against emerging SARS-CoV-2 variants. There are few uncertainties about vaccine safety including the absence of clinical trial data in pregnant women (and the impact on the unborn child), children and adolescents. Conclusions: Notwithstanding the knowledge gaps about effectiveness and safety of COVID-19 vaccines (to be further addressed by observational studies), there is overwhelming evidence that public health benefits of vaccination by far outweigh any foreseeable risk. |
id |
FIOCRUZ-9_ac259317df86c84e27a7cb748cb1bfa6 |
---|---|
oai_identifier_str |
oai:ojs.visaemdebate.incqs.fiocruz.br:article/1881 |
network_acronym_str |
FIOCRUZ-9 |
network_name_str |
Vigilância Sanitária em Debate |
repository_id_str |
|
spelling |
On the safety and effectiveness of COVID-19 vaccines, certainties and uncertaintiesOn the safety and effectiveness of COVID-19 vaccines, certainties and uncertaintiesCOVID-19; Vacinas; Eventos Adversos; Ensaios Aleatorizados Controlados com PlaceboCOVID-19; Vaccines; Adverse Events; Randomized Placebo-controlled TrialsIntroduction: The COVID-19 vaccines in use (inactivaded virus, encapsulated m-RNA, non-replicating adenovirus-vectored DNA) were clinically tested in randomized placebocontrolled phase-3 studies. Objective: To address certainties and uncertainties about safety and effectiveness of COVID-19 vaccines that were approved for use in various countries. Method: The evidence provided by clinical studies on the efficacy and safety of COVID-19 vaccines was critically appraised. Results: COVID-19 vaccines proved to be efficacious and safe in clinical trials. Adverse events were mostly those of minor severity commonly noted with other vaccines such as injection site pain, mild flu-like symptoms, headache and asthenia. Although being very rare, anaphylaxis-like reactions were noted with mRNA vaccines. Uncertainties regarding vaccine effectiveness refer mainly to the (long-term) duration of immunity provided by vaccination, the degree of protection conferred to elderly people, and how effective vaccines are against emerging SARS-CoV-2 variants. There are few uncertainties about vaccine safety including the absence of clinical trial data in pregnant women (and the impact on the unborn child), children and adolescents. Conclusions: Notwithstanding the knowledge gaps about effectiveness and safety of COVID-19 vaccines (to be further addressed by observational studies), there is overwhelming evidence that public health benefits of vaccination by far outweigh any foreseeable risk.TÍTULO PT: Sobre a segurança e efetividade das vacinas para COVID-19, certezas e incertezas Introdução: As vacinas contra COVID-19 (vírus inativado, m-RNA encapsulado, vetor adenovírus não replicante) foram testadas em ensaios clínicos randomizados (fase-3) controlados com placebo. Objetivo: Abordar as certezas e incertezas sobre segurança e efetividade das vacinas para COVID-19 já aprovadas para uso em vários países. Método: A evidência clínica de eficácia e segurança das vacinas contra COVID-19 foram examinadas criticamente. Resultados: As vacinas (COVID-19) mostraram ser eficazes e seguras nos ensaios clínicos. Os eventos adversos foram predominantemente os de menor gravidade comumente observados com outras vacinas, tais como dor no local da injeção, sintomas gripais leves, cefaleia e fraqueza. Embora sejam raras, reações do tipo anafilático foramregistradas com vacinas mRNA. As incertezas sobre efetividade referem-se à duração da imunidade conferida pela vacina, o grau de proteção de idosos, e a efetividade das vacinas contra as novas variantes do SARS-CoV-2. As incertezas sobre segurança são poucas e incluem a ausência de estudos clínicos em grávidas (e sobre o bebê no útero), em crianças e adolescentes. Conclusões: Não obstante as poucas lacunas acerca da efetividade e segurança das vacinas contra COVID-19 (a serem abordadas por estudos observacionais), os previsíveis benefícios da vacinação para a saúde pública excedem de longe quaisquer riscos antecipáveis.Instituto Nacional de Controle de Qualidade em Saúde2021-11-30info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/188110.22239/2317-269x.01881Health Surveillance under Debate: Society, Science & Technology ; Vol. 9 No. 4 (2021): November; 16-24Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 9 Núm. 4 (2021): Noviembre; 16-24Vigil Sanit Debate, Rio de Janeiro; v. 9 n. 4 (2021): Novembro; 16-242317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZengporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1881/1357https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1881/1635Copyright (c) 2021 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessAmado Xavier de Oliveira , Ana Cecilia Fernandes Delgado , Isabella José Roma Paumgartten, Francisco 2024-04-03T19:07:08Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1881Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2024-04-03T19:07:08Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties |
title |
On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties |
spellingShingle |
On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties Amado Xavier de Oliveira , Ana Cecilia COVID-19; Vacinas; Eventos Adversos; Ensaios Aleatorizados Controlados com Placebo COVID-19; Vaccines; Adverse Events; Randomized Placebo-controlled Trials |
title_short |
On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties |
title_full |
On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties |
title_fullStr |
On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties |
title_full_unstemmed |
On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties |
title_sort |
On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties |
author |
Amado Xavier de Oliveira , Ana Cecilia |
author_facet |
Amado Xavier de Oliveira , Ana Cecilia Fernandes Delgado , Isabella José Roma Paumgartten, Francisco |
author_role |
author |
author2 |
Fernandes Delgado , Isabella José Roma Paumgartten, Francisco |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Amado Xavier de Oliveira , Ana Cecilia Fernandes Delgado , Isabella José Roma Paumgartten, Francisco |
dc.subject.por.fl_str_mv |
COVID-19; Vacinas; Eventos Adversos; Ensaios Aleatorizados Controlados com Placebo COVID-19; Vaccines; Adverse Events; Randomized Placebo-controlled Trials |
topic |
COVID-19; Vacinas; Eventos Adversos; Ensaios Aleatorizados Controlados com Placebo COVID-19; Vaccines; Adverse Events; Randomized Placebo-controlled Trials |
description |
Introduction: The COVID-19 vaccines in use (inactivaded virus, encapsulated m-RNA, non-replicating adenovirus-vectored DNA) were clinically tested in randomized placebocontrolled phase-3 studies. Objective: To address certainties and uncertainties about safety and effectiveness of COVID-19 vaccines that were approved for use in various countries. Method: The evidence provided by clinical studies on the efficacy and safety of COVID-19 vaccines was critically appraised. Results: COVID-19 vaccines proved to be efficacious and safe in clinical trials. Adverse events were mostly those of minor severity commonly noted with other vaccines such as injection site pain, mild flu-like symptoms, headache and asthenia. Although being very rare, anaphylaxis-like reactions were noted with mRNA vaccines. Uncertainties regarding vaccine effectiveness refer mainly to the (long-term) duration of immunity provided by vaccination, the degree of protection conferred to elderly people, and how effective vaccines are against emerging SARS-CoV-2 variants. There are few uncertainties about vaccine safety including the absence of clinical trial data in pregnant women (and the impact on the unborn child), children and adolescents. Conclusions: Notwithstanding the knowledge gaps about effectiveness and safety of COVID-19 vaccines (to be further addressed by observational studies), there is overwhelming evidence that public health benefits of vaccination by far outweigh any foreseeable risk. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-11-30 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Peer-reviewed article" "Artículo revisado por pares" "Artigo avaliado pelos pares" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1881 10.22239/2317-269x.01881 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1881 |
identifier_str_mv |
10.22239/2317-269x.01881 |
dc.language.iso.fl_str_mv |
eng por |
language |
eng por |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1881/1357 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1881/1635 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc/4.0/ |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
dc.source.none.fl_str_mv |
Health Surveillance under Debate: Society, Science & Technology ; Vol. 9 No. 4 (2021): November; 16-24 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 9 Núm. 4 (2021): Noviembre; 16-24 Vigil Sanit Debate, Rio de Janeiro; v. 9 n. 4 (2021): Novembro; 16-24 2317-269X reponame:Vigilância Sanitária em Debate instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Vigilância Sanitária em Debate |
collection |
Vigilância Sanitária em Debate |
repository.name.fl_str_mv |
Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br |
_version_ |
1797042046534418432 |