title: A review of the changes to the licensing of influenza vaccines in Europe.
abstract: In 2014, the European Committee for Medicinal Products for Human Use (CHMP) published a draft regulatory guideline for the evaluation of influenza vaccines. Following a public consultation round, the final guidance will be published in the near future. Here, we highlight the main changes in the clinical section in this guideline and discuss the background to these changes and whether the new consolidated guidance document can be expected to achieve a better understanding of the performance of seasonal, zoonotic and pandemic influenza vaccines during the regulatory licensing process. The new influenza guideline reflects a changed approach to the regulatory assessment of influenza vaccines, resulting in the abolition of serological criteria, known as the CHMP criteria, which have been the mainstay for evaluating the influenza vaccine immunogenicity for several decades. The new guideline adopts a more diversified approach to the measurement and reporting of the immune response to influenza vaccines and sets a requirement to conduct clinical outcome trials in young children. Importantly, more emphasis is placed on the post-licensure monitoring of the benefit risk of influenza vaccines, including a request for continuous monitoring of efficacy and enhanced safety surveillance. Despite the improvements these new requirements will expectedly bring to the regulatory assessment of influenza vaccines, major challenges remain which cannot be overcome by new guidance alone. Ongoing initiatives in which academia, manufacturers, public health institutes and regulators work together to address these challenges are central to the development of robust tools to evaluate and monitor performance of influenza vaccines in the future.
authors.affiliation: Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: Leonoor
authors.initials: L
authors.lastname: Wijnans
authors.affiliation: Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: Bettie
authors.initials: B
authors.lastname: Voordouw
mesh_terms: D005060:Europe; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage*; D007251:Influenza, Human / Q000517:prevention & control; D008004:Licensure; D017410:Practice Guidelines as Topic; D014611:Vaccination / Q000331:legislation & jurisprudence*
chemical_list: D007252:Influenza Vaccines
keywords: influenza; pandemic vaccine; regulatory guidance; seasonal vaccine; strain change; zoonotic vaccine