2021 will be marked by the vaccination programs against SARS-CoV-2. Currently, various Member States are setting priorities in the vaccination programs for specific groups of patients, including those with rare diseases. On the other hand, there are some rare disease patients for whom vaccination can be contraindicated.
As European Reference Networks (ERNs) are formed by experts in rare diseases, we asked all ERNs to provide their opinion on the priorities and contraindications for patients with a rare disease within their network. The results are summarized in this document and were discussed during the internal ERN-Coordinator group meeting of January 27th, 2021.
First of all, we advise that the general recommendations of the EMA regarding new medicines need to be followed. Unfortunately, the recommendations below will not be complete, and only apply to the adult population. Moreover, these recommendations are based on the expert opinion as evidence is lacking for the majority of rare diseases. When evidence is available this is mentioned in the statement.It is very important that evidence is gathered regarding rare disease patients in the vaccination program, even better will be to set up clinical trials.
This expert opinion-based document with recommendations for adults only, can be no more than a start with the ultimate goal to have a complete overview of recommendations within the years to come, and therefore will need very regular updates. Up to date positions will be available on the websites of many ERNs.