EMA and ECDC propose harmonised EU child vaccine trial schedule


With the aim of avoiding duplicating similar clinical trials

A single development plan for European Union (EU) pharmaceutical companies developing new vaccines to protect children against diphtheria, tetanus and whooping cough has been released by the European Medicines Agency (EMA).

The proposal aims to harmonise how these vaccines are developed to avoid duplicating similar clinical trials.

The EMA stressed that routine childhood vaccination programmes had successfully controlled these diseases, but 'as the schedules of child vaccinations vary slightly between countries, a large number of fairly similar clinical trials are conducted in children when a new vaccine is being developed'.

As a result, the EMA and the European Centre for Disease Prevention and Control (ECDC) have created a single schedule for clinical trials in children producing data relevant to EU national vaccination schedules. This involves two priming doses at two and four months and a booster dose at 12 months, with potential additional studies for combined vaccines.

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The EMA is inviting comments about the proposal, which should be emailed to paediatrics@ema.europa.eu by 19 December.