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First-in-human clinical trials with vaccines—what regulators want

Nature Biotechnology volume 28, pages 910–916 (2010)Cite this article

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Several factors should be taken into account when it comes to the first exposure of humans to a novel vaccine.

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Author information

Authors and Affiliations

  1. Karen B. Goetz, Michael Pfleiderer and Christian K. Schneider are at the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.,

    Karen B Goetz, Michael Pfleiderer & Christian K Schneider

  2. Michael Pfleiderer is the chairman of the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) Vaccines Working Party (VWP) and the German member of the EMA CHMP Biologics Working Party (BWP).,

    Michael Pfleiderer

  3. Christian K. Schneider is also at the Twincore Centre for Experimental and Clinical Infection Research, Hannover, Germany and is a member of the EMA Committee for Medicinal Products for Human Use (CHMP), and the chairman of the EMA Committee for Advanced Therapies (CAT).,

    Christian K Schneider

Authors
  1. Karen B Goetz
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  2. Michael Pfleiderer
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  3. Christian K Schneider
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Corresponding author

Correspondence to Karen B Goetz.

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The authors declare no competing financial interests.

Additional information

The views expressed in this article are our personal views and may not be understood or quoted as being made on behalf of the EMA committees or reflecting the position of the EMA committees or one of the CHMP Working Parties.

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Goetz, K., Pfleiderer, M. & Schneider, C. First-in-human clinical trials with vaccines—what regulators want. Nat Biotechnol 28, 910–916 (2010). https://doi.org/10.1038/nbt0910-910

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