A Quantitative Benefit–Risk Analysis of ChAdOx1 nCoV-19 Vaccine among People under 60 in Italy
The Oxford-AstraZeneca ChAdOx1 nCoV-19 is a vaccine against the COVID-19 infection that was granted a conditional marketing authorization by the European Commission in January 2021. However, following a report from the Pharmacovigilance Risk Assessment Committee (PRAC) of European Medicines Agency,...
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| Format: | Article |
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MDPI AG
2021-06-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/9/6/618 |
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| author | Raffaele Palladino Daniele Ceriotti Damiano De Ambrosi Marta De Vito Marco Farsoni Giuseppina Seminara Francesco Barone-Adesi |
| author_facet | Raffaele Palladino Daniele Ceriotti Damiano De Ambrosi Marta De Vito Marco Farsoni Giuseppina Seminara Francesco Barone-Adesi |
| author_sort | Raffaele Palladino |
| collection | DOAJ |
| description | The Oxford-AstraZeneca ChAdOx1 nCoV-19 is a vaccine against the COVID-19 infection that was granted a conditional marketing authorization by the European Commission in January 2021. However, following a report from the Pharmacovigilance Risk Assessment Committee (PRAC) of European Medicines Agency, which reported an association with thrombo-embolic events (TEE), in particular disseminated intravascular coagulation (DIC) and cerebral venous sinus thrombosis (CVST), many European countries either limited it to individuals older than 55–60 years or suspended its use. We used publicly available data to carry out a quantitative benefit–risk analysis of the vaccine among people under 60 in Italy. Specifically, we used data from PRAC, Eudravigilance and ECDC to estimate the excess number of deaths for TEE, DIC and CVST expected in vaccine users, stratified by age groups. We then used data from the National Institute of Health to calculate age-specific COVID-19 mortality rates in Italy. Preventable deaths were calculated assuming a 72% vaccine efficacy over an eight-month period. Finally, the benefit–risk ratio of ChAdOx1 nCoV-19 vaccination was calculated as the ratio of preventable COVID-19 deaths to vaccine-related deaths, using Monte-Carlo simulations. We found that among subjects aged 20–29 years the benefit–risk (B-R) ratio was not clearly favorable (0.70; 95% Uncertainty Interval (UI): 0.27–2.11). However, in the other age groups the benefits of vaccination largely exceeded the risks (for age 30–49, B-R ratio: 22.9: 95%UI: 10.1–186.4). For age 50–59, B-R ratio: 1577.1: 95%UI: 1176.9–2121.5). Although many countries have limited the use of the ChAdOx1 nCoV-19 vaccine, the benefits of using this vaccine clearly outweigh the risks in people older than 30 years. Study limitations included risk of underreporting and that we did not provide age-specific estimates. The use of this vaccine should be a strategic and fundamental part of the immunization campaign considering its safety and efficacy in preventing COVID-19 and its complications. |
| first_indexed | 2024-03-10T10:35:53Z |
| format | Article |
| id | doaj.art-2ae5f74b2ef547d5a26da89028d9d1a3 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-10T10:35:53Z |
| publishDate | 2021-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-2ae5f74b2ef547d5a26da89028d9d1a32023-11-21T23:18:04ZengMDPI AGVaccines2076-393X2021-06-019661810.3390/vaccines9060618A Quantitative Benefit–Risk Analysis of ChAdOx1 nCoV-19 Vaccine among People under 60 in ItalyRaffaele Palladino0Daniele Ceriotti1Damiano De Ambrosi2Marta De Vito3Marco Farsoni4Giuseppina Seminara5Francesco Barone-Adesi6Department of Public Health, University “Federico II” of Naples, 80131 Napoli, ItalyDepartment of Translational Medicine, University of Eastern Piedmont, 28100 Novara, ItalyDepartment of Translational Medicine, University of Eastern Piedmont, 28100 Novara, ItalyDepartment of Translational Medicine, University of Eastern Piedmont, 28100 Novara, ItalyDepartment of Translational Medicine, University of Eastern Piedmont, 28100 Novara, ItalyDepartment of Translational Medicine, University of Eastern Piedmont, 28100 Novara, ItalyDepartment of Translational Medicine, University of Eastern Piedmont, 28100 Novara, ItalyThe Oxford-AstraZeneca ChAdOx1 nCoV-19 is a vaccine against the COVID-19 infection that was granted a conditional marketing authorization by the European Commission in January 2021. However, following a report from the Pharmacovigilance Risk Assessment Committee (PRAC) of European Medicines Agency, which reported an association with thrombo-embolic events (TEE), in particular disseminated intravascular coagulation (DIC) and cerebral venous sinus thrombosis (CVST), many European countries either limited it to individuals older than 55–60 years or suspended its use. We used publicly available data to carry out a quantitative benefit–risk analysis of the vaccine among people under 60 in Italy. Specifically, we used data from PRAC, Eudravigilance and ECDC to estimate the excess number of deaths for TEE, DIC and CVST expected in vaccine users, stratified by age groups. We then used data from the National Institute of Health to calculate age-specific COVID-19 mortality rates in Italy. Preventable deaths were calculated assuming a 72% vaccine efficacy over an eight-month period. Finally, the benefit–risk ratio of ChAdOx1 nCoV-19 vaccination was calculated as the ratio of preventable COVID-19 deaths to vaccine-related deaths, using Monte-Carlo simulations. We found that among subjects aged 20–29 years the benefit–risk (B-R) ratio was not clearly favorable (0.70; 95% Uncertainty Interval (UI): 0.27–2.11). However, in the other age groups the benefits of vaccination largely exceeded the risks (for age 30–49, B-R ratio: 22.9: 95%UI: 10.1–186.4). For age 50–59, B-R ratio: 1577.1: 95%UI: 1176.9–2121.5). Although many countries have limited the use of the ChAdOx1 nCoV-19 vaccine, the benefits of using this vaccine clearly outweigh the risks in people older than 30 years. Study limitations included risk of underreporting and that we did not provide age-specific estimates. The use of this vaccine should be a strategic and fundamental part of the immunization campaign considering its safety and efficacy in preventing COVID-19 and its complications.https://www.mdpi.com/2076-393X/9/6/618COVID-19vaccineChAdOx1 nCoV-19benefit–risk analysisthrombo-embolic events |
| spellingShingle | Raffaele Palladino Daniele Ceriotti Damiano De Ambrosi Marta De Vito Marco Farsoni Giuseppina Seminara Francesco Barone-Adesi A Quantitative Benefit–Risk Analysis of ChAdOx1 nCoV-19 Vaccine among People under 60 in Italy Vaccines COVID-19 vaccine ChAdOx1 nCoV-19 benefit–risk analysis thrombo-embolic events |
| title | A Quantitative Benefit–Risk Analysis of ChAdOx1 nCoV-19 Vaccine among People under 60 in Italy |
| title_full | A Quantitative Benefit–Risk Analysis of ChAdOx1 nCoV-19 Vaccine among People under 60 in Italy |
| title_fullStr | A Quantitative Benefit–Risk Analysis of ChAdOx1 nCoV-19 Vaccine among People under 60 in Italy |
| title_full_unstemmed | A Quantitative Benefit–Risk Analysis of ChAdOx1 nCoV-19 Vaccine among People under 60 in Italy |
| title_short | A Quantitative Benefit–Risk Analysis of ChAdOx1 nCoV-19 Vaccine among People under 60 in Italy |
| title_sort | quantitative benefit risk analysis of chadox1 ncov 19 vaccine among people under 60 in italy |
| topic | COVID-19 vaccine ChAdOx1 nCoV-19 benefit–risk analysis thrombo-embolic events |
| url | https://www.mdpi.com/2076-393X/9/6/618 |
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