{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T14:24:06Z","timestamp":1787408646947,"version":"build-2736575974"},"reference-count":32,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T00:00:00Z","timestamp":1784505600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T00:00:00Z","timestamp":1784505600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>The recent adoption of mRNA\u2010based technology for vaccine development has led to widespread exposure to new vaccine components, such as polyethylene glycol (PEG), against which antibodies may be made. This study assesses the presence of anti\u2010PEG antibodies in human serum following SARS\u2010CoV\u20102 vaccination, and if these antibodies could interfere with drug level assessment of PEG containing drugs. Elevated anti\u2010PEG antibody titers with prolonged prevalence were detected in individuals who received the mRNA\u20101273 vaccine as compared to control samples. Anti\u2010PEG antibody levels were approximately 10\u2010fold higher post\u2010vaccination compared to pre\u2010vaccination in approximately 33% of assessed mRNA\u20101273 vaccine recipients. Elevated anti\u2010PEG antibody levels persisted for over 6\u2009months. Serum from those who received the BNT162b2 or Ad26.COV2.S vaccines had anti\u2010PEG antibody levels similar to control samples. Serum from individuals with elevated anti\u2010PEG antibodies, regardless of study group, typically showed decreased detection of the pegylated drug, pegfilgrastim. This study demonstrates that anti\u2010PEG antibodies have the potential to interfere with bioanalytical assays used for pharmacokinetic drug measurement during the development of pegylated pharmaceutical products, as well as during the establishment of comparability to pegylated reference products during development of biosimilar drug products.<\/jats:p>","DOI":"10.1111\/cts.70667","type":"journal-article","created":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T03:31:03Z","timestamp":1784604663000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Anti\u2010\n                    <scp>PEG<\/scp>\n                    Antibodies From\n                    <scp>mRNA COVID<\/scp>\n                    \u201019 Vaccines Affect In\u00a0Vitro Measurements of Pegylated Drug Levels"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5320-0098","authenticated-orcid":false,"given":"Elizaveta A.","family":"Svyatova","sequence":"first","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food &amp; 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Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0463-9699","authenticated-orcid":false,"given":"Rodney","family":"Rouse","sequence":"additional","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food &amp; Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8891-754X","authenticated-orcid":false,"given":"Kristina E.","family":"Howard","sequence":"additional","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food &amp; Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,20]]},"reference":[{"issue":"4","key":"e_1_2_10_2_1","first-page":"322","article-title":"Discovery and Uses of Pegvisomant: A Growth Hormone Antagonist","volume":"58","author":"Berryman D. 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