Abstract
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.
Highlights
This article is an open access articleThe Oxford-AstraZeneca ChAdOx1 nCov-19 vaccine is a recombinant chimpanzee adenoviral vector encoding the SARS-CoV-2 spike glycoprotein [1,2]
Vaccine marketing authorization was provided by the European Medicine Agency (EMA) on 29 January 2021 [4], while the World Health Organization (WHO) approved its use on 15 February 2021 after it was distributed under the terms and conditions of the Creative Commons
Even if the EMA has not changed since the indications for the recommended age groups to receive the vaccine [4], many countries, including Italy, currently recommend the use of vaccination only for subjects over 60 years, without prejudice to the need to give the second dose to younger subjects who have already received the first dose and have not presented adverse events
Summary
The Oxford-AstraZeneca ChAdOx1 nCov-19 vaccine is a recombinant chimpanzee adenoviral vector encoding the SARS-CoV-2 spike glycoprotein [1,2]. Evaluated by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) [5]. Following this evaluation, this two-dose vaccination was initially recommended for individuals over the age of 18 [6]. In March 2021, the use of ChAdOx1 nCoV-19 vaccine was paused in a number of European countries due to the reports of thromboembolic events (TEE), in particular involving unusual locations such as cerebral venous sinus and splanchnic circulation [7]
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