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<front>
<journal-meta>
<journal-id journal-id-type="publisher-id">JDS</journal-id>
<journal-title-group><journal-title>Journal of Data Science</journal-title></journal-title-group>
<issn pub-type="epub">1683-8602</issn><issn pub-type="ppub">1680-743X</issn><issn-l>1680-743X</issn-l>
<publisher>
<publisher-name>School of Statistics, Renmin University of China</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="publisher-id">JDS1240</article-id>
<article-id pub-id-type="doi">10.6339/26-JDS1240</article-id>
<article-categories><subj-group subj-group-type="heading">
<subject>Statistical Data Science</subject></subj-group></article-categories>
<title-group>
<article-title>Bayesian Dynamic Borrowing for Vaccine Efficacy Studies in Pediatric Population</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name><surname>Qian</surname><given-names>Ruoyuan</given-names></name><xref ref-type="aff" rid="j_jds1240_aff_001">1</xref>
</contrib>
<contrib contrib-type="author">
<name><surname>Yuan</surname><given-names>Wenlin</given-names></name><xref ref-type="aff" rid="j_jds1240_aff_002">2</xref>
</contrib>
<contrib contrib-type="author">
<name><surname>Gao</surname><given-names>Lei</given-names></name><email xlink:href="mailto:lei.gao@modernatx.com">lei.gao@modernatx.com</email><xref ref-type="aff" rid="j_jds1240_aff_002">2</xref><xref ref-type="corresp" rid="cor1">∗</xref>
</contrib>
<aff id="j_jds1240_aff_001"><label>1</label>Division of Biostatistics, <institution>The Ohio State University</institution>, Columbus, OH, <country>USA</country></aff>
<aff id="j_jds1240_aff_002"><label>2</label>Department of Biostatistics and Programming, <institution>Moderna</institution>, Cambridge, MA, <country>USA</country></aff>
</contrib-group>
<author-notes>
<corresp id="cor1"><label>∗</label>Corresponding author. Email: <ext-link ext-link-type="uri" xlink:href="mailto:lei.gao@modernatx.com">lei.gao@modernatx.com</ext-link>.</corresp>
</author-notes>
<pub-date pub-type="ppub"><year>2026</year></pub-date><pub-date pub-type="epub"><day>21</day><month>7</month><year>2026</year></pub-date><volume content-type="ahead-of-print">0</volume><issue>0</issue><fpage>1</fpage><lpage>19</lpage><supplementary-material id="S1" content-type="archive" xlink:href="jds1240_s001.zip" mimetype="application" mime-subtype="x-zip-compressed">
<caption>
<title>Supplementary Material</title>
<p>The R code used to reproduce the simulation results is provided as online Supplementary Material.</p>
</caption>
</supplementary-material><history><date date-type="received"><day>21</day><month>11</month><year>2025</year></date><date date-type="accepted"><day>28</day><month>6</month><year>2026</year></date></history>
<permissions><copyright-statement>2026 The Author(s). Published by the School of Statistics and the Center for Applied Statistics, Renmin University of China.</copyright-statement><copyright-year>2026</copyright-year>
<license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by/4.0/">
<license-p>Open access article under the <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">CC BY</ext-link> license.</license-p></license></permissions>
<abstract>
<p>Pediatric vaccine efficacy studies face enrollment challenges, often resulting in underpowered studies to confirm vaccine efficacy. To address the challenge, this paper proposes a novel Two-Tier Bayesian dynamic borrowing framework that selectively incorporates two heterogeneous sources of historical data of adult populations into pediatric studies. The method employs similarity metrics based on intermediate outcomes, such as immunological markers, to dynamically determine borrowing weights via overlap coefficients, ensuring that only comparable data are utilized. Power priors are constructed with weights reflecting this similarity, while a cap on the effective sample size helps maintain control of the maximum information to borrow. Simulation studies demonstrate that the proposed approach improves power, reduces estimation bias and maintains type I error control, thus offering a robust and practical strategy for pediatric vaccine study design.</p>
</abstract>
<kwd-group>
<label>Keywords</label>
<kwd>effective sample size</kwd>
<kwd>historical borrowing</kwd>
<kwd>pediatric vaccine trials</kwd>
<kwd>power prior</kwd>
</kwd-group>
</article-meta>
</front>
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