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At the start of the pandemic, no vaccines or anti-viral treatments were available to reduce the burden of disease associated with this virus, as it was a novel SARS coronavirus. Because of the tremendous need, the development of vaccines to protect against COVID-19 was critically important. The flexibility and ease of manufacture of nucleic acid\u2013based vaccines, specifically mRNA-based products, allowed the accelerated development of COVID-19 vaccines. Although mRNA-based vaccines and therapeutics had been in clinical trials for over a decade, there were no licensed mRNA vaccines on the market at the start of the pandemic. The rapid development of mRNA-based COVID-19 vaccines reduced serious complications and death from the virus but also engendered significant public concerns, which continue now, years after emergency-use authorization and subsequent licensure of these vaccines. This article summarizes and addresses some of the safety concerns that continue to be expressed about these vaccines and their underlying technology.<\/jats:p>","DOI":"10.1177\/01926233241278298","type":"journal-article","created":{"date-parts":[[2024,9,10]],"date-time":"2024-09-10T10:03:26Z","timestamp":1725962606000},"page":"333-342","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Toxicologic Pathology Forum: mRNA Vaccine Safety\u2013Separating Fact From Fiction"],"prefix":"10.1177","volume":"52","author":[{"given":"Rani S.","family":"Sellers","sequence":"first","affiliation":[{"name":"The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip R.","family":"Dormitzer","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Waltham, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,9,10]]},"reference":[{"key":"bibr1-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1111\/dth.15458"},{"key":"bibr2-01926233241278298","doi-asserted-by":"publisher","DOI":"10.3390\/cimb44030073"},{"key":"bibr3-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1186\/s12876-022-02507-3"},{"key":"bibr4-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.122.321881"},{"key":"bibr5-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1007\/s10875-021-01187-0"},{"key":"bibr6-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1126\/science.abn8934"},{"key":"bibr7-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-021-22446-z"},{"key":"bibr8-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2035389"},{"key":"bibr9-01926233241278298","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.2100637"},{"key":"bibr10-01926233241278298","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm7035e5"},{"key":"bibr11-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2021.05.007"},{"key":"bibr12-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.121.056135"},{"key":"bibr13-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1002\/prca.202300048"},{"key":"bibr14-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1002\/jat.4548"},{"key":"bibr15-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1097\/MJT.0000000000001402"},{"key":"bibr16-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1016\/j.antiviral.2020.104787"},{"key":"bibr17-01926233241278298","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.1400623"},{"key":"bibr18-01926233241278298","doi-asserted-by":"publisher","DOI":"10.1111\/apm.13294"},{"issue":"27","key":"bibr19-01926233241278298","first-page":"577","volume":"48","author":"Centers for Disease Control and Prevention","year":"1999","journal-title":"MMWR Morb Mortal Wkly Rep"},{"issue":"43","key":"bibr20-01926233241278298","first-page":"1007","volume":"48","author":"Centers for Disease Control and Prevention","year":"1999","journal-title":"MMWR Morb Mortal Wkly"},{"key":"bibr21-01926233241278298","volume-title":"Assessment Report. 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