The European Medicines Agency (EMA) has published a draft concept paper on the clinical development of vaccines in immunocompromised individuals. EMA is seeking feedback on the draft paper to inform the creation of an addendum to an existing guideline on the clinical evaluation of vaccines.
The current guideline lacks detailed guidance on the design of clinical trials to assess the safety, immunogenicity and efficacy of vaccines in immunocompromised individuals, according to EMA. Immunocompromised individuals are commonly excluded from pre-approval trials and, as such, at the time of authorization it is unknown if the dose is right for some, or all, of the heterogeneous population of patients with different types and degrees of immunosuppression. Post-authorization trials can suffer from slow enrollment or fail to deliver useful information…
