Posted by Michael Wonder on 26 Apr 2018
Updated rules for clinical development of vaccines
26 April 2018 - EMA launches public consultation on revised guideline on clinical evaluation of vaccines.
EMA’s draft guideline includes specific considerations for clinical trials with vaccines in special populations, such as pregnant women or the elderly.
The revised version of the guideline 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 need to develop vaccine for pathogens that may cause future epidemics and for which conducting clinical trials outside of outbreaks might be problematic, is also addressed.
