Follow-up studies of COVID-19 vaccines

Follow-up studies of COVID‍-‍19 vaccines may require a permit from the Swedish Medical Products Agency. The information on this page refers to clinical trials conducted in accordance with national legislation based on EU Directive 2001/20/EC and EU Clinical Trials Regulation No 536/2014.

Research studies, which are carried out to study the efficacy or safety of approved COVID-19 vaccines are, according to the definitions in the regulations, subject to interventional clinical trials if they include sampling/diagnostic procedures or monitoring procedures in addition to those included in clinical practice. This also applies if the vaccination itself takes place outside the trial and if the intervention is limited to following the subjects' immune responses through, for example, blood sampling.

In accordance with Good Clinical Practice (ICH GCP/ICH E6(R2)), it is the sponsor's responsibility to decide on the basis of a risk assessment in the specific trial what measures are required to ensure the quality of the trial, i.e. to ensure the subjects' rights and safety and to obtain reliable data. Such risk assessment shall be described in the protocol and risk assessment may include safety reporting, handling of medicinal products, monitoring and trial documentation.

Contact the Department of Clinical Trials and Special Permissions at the Swedish Medical Products Agency for more information if you intend to start a follow‍-‍up study to investigate the efficacy and safety of approved COVID‍-‍19 vaccines.

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