Key result
New adjuvants for human vaccines face a slow approval process in the EU due to regulatory concerns and bottlenecks regarding safety at preclinical and clinical stages.
The paper highlights EU regulatory expectations and bottlenecks regarding safety at preclinical and clinical stages for new adjuvants in human vaccines.
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Delays new adjuvant options for clinicians; leaves open targeted research on streamlined EU safety pathways.
This paper discusses EU regulatory texts that are relevant for the introduction of new adjuvants in human vaccines and discusses the EU requirements at the developmental level, during the manufacturing process and at the final product stage. The emphasis is on regulatory expectations regarding safety at preclinical and clinical stages. The article highlights regulatory concerns and existing bottlenecks that have led to a slow approval process for new adjuvants.
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Sesardic et al. (2007) conducted a review in Vaccine adjuvants. New adjuvants was evaluated. New adjuvants for human vaccines face a slow approval process in the EU due to regulatory concerns and bottlenecks regarding safety at preclinical and clinical stages.
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