Guidelines on drug and vaccines development are very useful, as they indicate the most successful process to be implemented. The EMA has now released an addendum to its “Guideline on clinical development of vaccines” for public consultation. This addendum specifically addresses clinical trials involving immunocompromised individuals, an area not covered in detail in the original guideline. It offers guidance on conducting studies to assess vaccine safety, immunogenicity, and efficacy in this population, either before or after vaccines receive marketing authorization. The goal is to support recommendations for vaccine use in the product information.

Public comments on the addendum are invited until 31 October 2024 through an EU survey.1

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References

  1. Committee for medicinal products for human use (CHMP). (2024). Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals. https://www.ema.europa.eu/en/documents/scientific-guideline/addendum-guideline-clinical-development-vaccines-address-clinical-trials-immunocompromised-individuals_en.pdf

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