A literature review and evidence-based evaluation of the Dutch national immunisation schedule yield possibilities for improvements.

National Immunisation Programmes (NIPs) develop historically. Its performance (disease incidences, vaccination coverage) is monitored. Reviewing the schedule as a whole could inform on further optimisation of the programme, i.

The Dutch Citizen's Understanding and Perception of the Actors Involved in the Netherlands' COVID-19 Pandemic Response: A Focus Group Study During the First Pandemic Wave.

Introduction: The COVID-19 pandemic was a public health emergency (PHE) of unprecedented magnitude and impact. It provided the possibility to investigate the Dutch citizens' understanding and perception of the actors involved in the Dutch pandemic response as a PHE unfolded.

Methods: Three focus groups (FGs) were held with 16 Dutch citizens in June 2020.

Identifying the sectors involved in the European public health emergency preparedness and response: a systematic review.

Objectives: A systematic review was conducted with the aims of identifying sectors mentioned in the public health emergency preparedness and response (PHEPR) literature and mapping the involvement of those sectors in the seven PHEPR cycle domains.

Setting: A detailed search strategy was conducted in Embase and Scopus, covering the period between 1 January 2005 and 1 January 2020.

Methods: Published articles focusing on preparedness for and/or response to public health emergencies of multiple origins on the European continent were included.

Use of biomarkers in the context of orphan medicines designation in the European Union.

The use of biomarkers within the procedures of the Committee of Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) is discussed herein. The applications for Orphan Medicinal Product designation in the EU are evaluated at two stages. At the time of orphan designation application, the file undergoes an assessment to establish whether the proposed condition is a distinct and serious condition affecting not more than 5 in 10,000 people in the EU, and whether the product is plausible as a therapy for that condition.

Registration of influenza vaccines for children in Europe.

Current trivalent inactivated influenza vaccines (TIV) for seasonal use have all been licensed in the EU based on serological data only. European Medicines Agency (EMA) guidelines for development of influenza vaccines and acceptance criteria are in place for adults but not for children. The Paediatric Committee initiated a review of the literature on influenza vaccines for children, which led to the conclusion that for new influenza vaccines the Paediatric Investigation Plan (PIP) will need to include an efficacy trial.