On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties
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| Format: | Artículo científico |
| Langue: | en |
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Fundação Oswaldo Cruz
2021
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| _version_ | 1876465555438829568 |
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| author | Ana Cecilia Amado Xavier de Oliveira |
| author_facet | Ana Cecilia Amado Xavier de Oliveira |
| contents | On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties Ana Cecilia Amado Xavier de Oliveira Isabella Fernandes Delgado Francisco José Roma Paumgartten Multidisciplinaria (Ciencias Naturales y Exactas) 19 COVID Vaccines Adverse Events controlled Trials Introduction The COVID-19 vaccines in use (inactivaded virus, encapsulated m-RNA, non-replicating adenovirus-vectored DNA) were clinically tested in randomized placebo-controlled 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. 2021 artículo científico 2317-269X https://www.redalyc.org/articulo.oa?id=570572979003 https://www.redalyc.org/journal/5705/570572979003/ https://www.redalyc.org/journal/5705/570572979003/html/ https://www.redalyc.org/journal/5705/570572979003/570572979003.epub https://www.redalyc.org/journal/5705/570572979003/movil 10.22239/2317-269X.01881 en http://www.redalyc.org/revista.oa?id=5705 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia application/pdf Fundação Oswaldo Cruz Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Brasil) Num.4 Vol.9 |
| format | Artículo científico |
| id | redalyc_570572979003 |
| institution | Redalyc |
| language | en |
| publishDate | 2021 |
| publisher | Fundação Oswaldo Cruz |
| spellingShingle | On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties Ana Cecilia Amado Xavier de Oliveira Multidisciplinaria (Ciencias Naturales y Exactas) 19 COVID Vaccines Adverse Events controlled Trials On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties Ana Cecilia Amado Xavier de Oliveira Isabella Fernandes Delgado Francisco José Roma Paumgartten Multidisciplinaria (Ciencias Naturales y Exactas) 19 COVID Vaccines Adverse Events controlled Trials Introduction The COVID-19 vaccines in use (inactivaded virus, encapsulated m-RNA, non-replicating adenovirus-vectored DNA) were clinically tested in randomized placebo-controlled 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. 2021 artículo científico 2317-269X https://www.redalyc.org/articulo.oa?id=570572979003 https://www.redalyc.org/journal/5705/570572979003/ https://www.redalyc.org/journal/5705/570572979003/html/ https://www.redalyc.org/journal/5705/570572979003/570572979003.epub https://www.redalyc.org/journal/5705/570572979003/movil 10.22239/2317-269X.01881 en http://www.redalyc.org/revista.oa?id=5705 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia application/pdf Fundação Oswaldo Cruz Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Brasil) Num.4 Vol.9 |
| title | On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties |
| topic | Multidisciplinaria (Ciencias Naturales y Exactas) 19 COVID Vaccines Adverse Events controlled Trials |
| url | https://www.redalyc.org/articulo.oa?id=570572979003 https://www.redalyc.org/journal/5705/570572979003/ https://www.redalyc.org/journal/5705/570572979003/html/ https://www.redalyc.org/journal/5705/570572979003/570572979003.epub https://www.redalyc.org/journal/5705/570572979003/movil |