EMA-raadpleging: ontwerprichtlijn inzake klinische evaluatie van vaccins

The European Medicines Agency has released for public consultation a draft guideline on clinical evaluation of vaccines – Revision 1.

This guideline addresses the clinical evaluation of vaccines intended for the prevention of infectious diseases. It includes considerations for trials intended to document the safety, immunogenicity and efficacy of new candidate vaccines and to support changes in the prescribing information of licensed vaccines. It also considers the need for and use of vaccine effectiveness studies. The draft guideline includes specific considerations for clinical trials with vaccines in special populations, such as pregnant women or the elderly. It also adds considerations to priming and boosting strategies, including the option of heterologous prime-boost, which entails administration of one type of vaccine first followed by a different type of vaccine for the same pathogen later.

The draft guideline is available by clicking here.

Comments should be provided using this template and sent to VWP@ema.europa.eu by 30 October 2018.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

For more information on the European regulatory system for medicines, please click here (brochure available in all EU languages).