During the COVID-19 pandemic, the European Medicines Agency (EMA) is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation. EMA is achieving this by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines. At this link it is possible to find the list of the exceptional measures and a comparison with standard transparency. These measures aim to address the high interest for information and to support global research on COVID-19 medicines. They are in addition to the information EMA normally publishes on human medicines.
A study just published in Jama Pediatrics (L. Charles Bailey, et Al.) reiterates that for most children, COVID-19 does not pose a serious threat: in fact, children tend to get infected less than adults and, when this happens, they mostly develop mild symptoms. However, the chances that even the children develop a serious form are not remote and are conditioned (but not always) above all by the presence of other pathologies. For this reason EMA released an accelerated procedure for COVID-19 treatments and vaccines that foresees a revision of applications for agreement of a PIP (Paediatric Investigational Plan), deferrals or waivers for treatments and vaccines for COVID-19 in an expedited manner, in order to speed up these products’ development and approval.
