On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties
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...
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| Format: | Article |
| Language: | English |
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Fundação Oswaldo Cruz (FIOCRUZ)
2021-08-01
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| Series: | Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia |
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| Online Access: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1881 |
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| author | Ana Cecilia Amado Xavier de Oliveira Isabella Fernandes Delgado Francisco José Roma Paumgartten |
| author_facet | Ana Cecilia Amado Xavier de Oliveira Isabella Fernandes Delgado Francisco José Roma Paumgartten |
| author_sort | Ana Cecilia Amado Xavier de Oliveira |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-19T13:06:55Z |
| format | Article |
| id | doaj.art-fc01bc3f449a4cc99edb16d993fa8067 |
| institution | Directory Open Access Journal |
| issn | 2317-269X |
| language | English |
| last_indexed | 2024-12-19T13:06:55Z |
| publishDate | 2021-08-01 |
| publisher | Fundação Oswaldo Cruz (FIOCRUZ) |
| record_format | Article |
| series | Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia |
| spelling | doaj.art-fc01bc3f449a4cc99edb16d993fa80672022-12-21T20:20:01ZengFundação Oswaldo Cruz (FIOCRUZ)Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia2317-269X2021-08-019On the safety and effectiveness of COVID-19 vaccines, certainties and uncertaintiesAna Cecilia Amado Xavier de Oliveira 0Isabella Fernandes Delgado 1Francisco José Roma Paumgartten2Escola Nacional de Saúde Pública Sérgio Arouca, Fundação Oswaldo Cruz (ENSP/Fiocruz), Rio de Janeiro, RJ, BrasilInstituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, BrasilEscola Nacional de Saúde Pública Sérgio Arouca, Fundação Oswaldo Cruz (ENSP/Fiocruz), Rio de Janeiro, RJ, BrasilIntroduction: 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.https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1881COVID-19; Vaccines; Adverse Events; Randomized Placebo-controlled Trials |
| spellingShingle | Ana Cecilia Amado Xavier de Oliveira Isabella Fernandes Delgado Francisco José Roma Paumgartten On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia COVID-19; Vaccines; Adverse Events; Randomized Placebo-controlled Trials |
| title | 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_short | 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 |
| topic | COVID-19; Vaccines; Adverse Events; Randomized Placebo-controlled Trials |
| url | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1881 |
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