Follow-up studies of COVID-19 vaccines
Follow-up studies of COVID-19 vaccines may require a permit from the Swedish Medical Products Agency.
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.
Contact 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.