{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T11:37:59Z","timestamp":1761824279387},"reference-count":9,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2021,2,26]],"date-time":"2021-02-26T00:00:00Z","timestamp":1614297600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,2,26]],"date-time":"2021-02-26T00:00:00Z","timestamp":1614297600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Epidemiol"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Initial results from various phase-III trials on vaccines against SARS-CoV-2 are promising. For proper translation of these results to clinical guidelines, it is essential to determine how well the general population is reflected in the study populations of these trials. This study was conducted among 7162 participants (age-range: 51\u2013106\u00a0years; 58% women) from the Rotterdam Study. We quantified the proportion of participants that would be eligible for the nine ongoing phase-III trials. We further quantified the eligibility among participants at high risk to develop severe COVID-19. Since many trials were not explicit in their exclusion criterion with respect to \u2018acute\u2019 or \u2018unstable preexisting\u2019 diseases, we performed two analyses. First, we included all participants irrespective of this criterion. Second, we excluded persons with acute or \u2018unstable preexisting\u2019 diseases. 97% of 7162 participants was eligible for any trial with eligibility for separate trials ranging between 11\u201397%. For high-risk individuals the corresponding numbers were 96% for any trial with separate trials ranging from 5\u201396%. Importantly, considering persons ineligible due to \u2018acute\u2019 or \u2018unstable pre-existing\u2019 disease drastically dropped the eligibilities for all trials below 43% for the total population and below 36% for high-risk individuals. The eligibility for ongoing vaccine trials against SARS-CoV-2 can reduce by half depending on interpretation and application of a single unspecified exclusion criterion. This exclusion criterion in our study would especially affect the elderly and those with pre-existing morbidities. These findings thus indicate the difficulty as well as importance of developing clinical recommendations for vaccination and applying these to the appropriate target populations. This becomes especially paramount considering the fact that many countries worldwide have initiated their vaccination programs by first targeting the elderly and most vulnerable persons.<\/jats:p>","DOI":"10.1007\/s10654-021-00729-5","type":"journal-article","created":{"date-parts":[[2021,2,26]],"date-time":"2021-02-26T02:02:49Z","timestamp":1614304969000},"page":"319-324","update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["External validity of phase III trials on vaccines against SARS-CoV-2 to a middle-aged and elderly Western European population"],"prefix":"10.1007","volume":"36","author":[{"given":"Natalie","family":"Terzikhan","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Albert","family":"Hofman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jaap","family":"Goudsmit","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohammad Arfan","family":"Ikram","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,2,26]]},"reference":[{"key":"729_CR1","unstructured":"RIVM. Risicogroepen en COVID-19. 2020 10-11-2020]; Available from: https:\/\/www.rivm.nl\/coronavirus-covid-19\/risicogroepen."},{"issue":"9","key":"729_CR2","doi-asserted-by":"publisher","first-page":"807","DOI":"10.1007\/s10654-017-0321-4","volume":"32","author":"MA Ikram","year":"2017","unstructured":"Ikram MA, et al. The rotterdam study: 2018 update on objectives, design and main results. Eur J Epidemiol. 2017;32(9):807\u201350.","journal-title":"Eur J Epidemiol"},{"issue":"1","key":"729_CR3","doi-asserted-by":"publisher","first-page":"89","DOI":"10.1093\/ije\/dyp174","volume":"39","author":"OM Dekkers","year":"2010","unstructured":"Dekkers OM, et al. How to assess the external validity of therapeutic trials: a conceptual approach. Int J Epidemiol. 2010;39(1):89\u201394.","journal-title":"Int J Epidemiol"},{"key":"729_CR4","doi-asserted-by":"publisher","first-page":"b4538","DOI":"10.1136\/bmj.b4538","volume":"339","author":"L Pibouleau","year":"2009","unstructured":"Pibouleau L, et al. 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PLoS Med. 2019;16(2):e1002741.","journal-title":"PLoS Med"},{"issue":"18","key":"729_CR7","doi-asserted-by":"publisher","first-page":"1821","DOI":"10.1056\/NEJMoa070972","volume":"357","author":"MW Vernooij","year":"2007","unstructured":"Vernooij MW, et al. Incidental findings on brain MRI in the general population. N Engl J Med. 2007;357(18):1821\u20138.","journal-title":"N Engl J Med"},{"key":"729_CR8","unstructured":"Vektis. Factsheet Chronische aandoeningen bij 40-plussers. 2019; Available from: https:\/\/www.vektis.nl\/intelligence\/publicaties\/factsheet-chronische-aandoeningen-bij-40-plussers."},{"issue":"3","key":"729_CR9","doi-asserted-by":"publisher","first-page":"555","DOI":"10.1007\/s00038-013-0539-1","volume":"59","author":"V Winkler","year":"2014","unstructured":"Winkler V, et al. Response in individuals with and without foreign background and application to the National Cohort in Germany: which factors have an effect? Int J Public Health. 2014;59(3):555\u201363.","journal-title":"Int J Public Health"}],"container-title":["European Journal of Epidemiology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s10654-021-00729-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s10654-021-00729-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s10654-021-00729-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,4,9]],"date-time":"2021-04-09T02:05:28Z","timestamp":1617933928000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s10654-021-00729-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,2,26]]},"references-count":9,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021,3]]}},"alternative-id":["729"],"URL":"https:\/\/doi.org\/10.1007\/s10654-021-00729-5","relation":{},"ISSN":["0393-2990","1573-7284"],"issn-type":[{"value":"0393-2990","type":"print"},{"value":"1573-7284","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,2,26]]},"assertion":[{"value":"8 December 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 February 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 February 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"Authors declare no conflicts of interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The Rotterdam Study has been approved by the Medical Ethics Committee of the Erasmus MC (registration number MEC 02.1015) and by the Dutch Ministry of Health, Welfare and Sport (Population Screening Act WBO, license number 1071272-159521-PG). The Rotterdam Study Personal Registration Data collection is filed with the Erasmus MC Data Protection Officer under registration number EMC1712001. The Rotterdam Study has been entered into the Netherlands National Trial Register (NTR; ExternalRef removed) and into the WHO International Clinical Trials Registry Platform (ICTRP; ExternalRef removed) under shared catalogue number NTR6831. All participants provided written informed consent to participate in the study and to have their information obtained from treating physicians.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}