Adjuvanted (AS03) A/H1N1 2009 Pandemic Influenza Vaccines and Solid Organ Transplant Rejection: Systematic Signal Evaluation and Lessons Learnt

Gaël Dos Santos (), Harry A. Seifert (), Vincent Bauchau (), Vivek Shinde (), Dominique M. Barbeau () and Catherine Cohet ()
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Gaël Dos Santos: Business & Decision Life Sciences (on behalf of GSK)
Harry A. Seifert: GSK
Vincent Bauchau: GSK
Vivek Shinde: GSK
Dominique M. Barbeau: ID Biomedical Corporation of Quebec, dba GSK
Catherine Cohet: GSK

Drug Safety, 2017, vol. 40, issue 8, No 5, 693-702

Abstract: Abstract Introduction We investigated a signal of solid organ transplant (SOT) rejection after immunisation with (AS03) A/H1N1 2009 pandemic influenza vaccines. Methods Potential immunological mechanisms were reviewed and quantitative analyses were conducted. The feasibility of pharmacoepidemiological studies was explored. Results Overall results, including data from a pharmacoepidemiological study, support the safety of adjuvanted (AS03) pandemic influenza vaccination in SOT recipients. The regulatory commitment to evaluate the signal through a stepwise investigation was closed in 2014. Conclusion Lessons learned highlight the importance of investigating plausible biological mechanisms between vaccines and potentially associated adverse outcomes, and the importance of selecting appropriate study settings and designs for safety signal investigations.

Date: 2017
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DOI: 10.1007/s40264-017-0532-3

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