Clinical Trials During the COVID-19 Pandemic
The Paul-Ehrlich-Institut is currently receiving many inquiries about observational or non-interventional studies with approved vaccines against COVID-19. Additional blood sampling, diagnostic procedures, antibody determination and/or epitope and/or epitope mapping are to be performed on a regular basis.
Since the entry into force of the "Ersten Verordnung zur Änderung der Medizinischer Bedarf Versorgungssicherstellungsverordnung" (MedBVSV) came into force on 01.05.2021 (BAnz AT 30.04.2021 V4) such studies, which compared to medical practice require more extensive measures, such as blood sampling or non-invasive examinations, can be performed with approved COVID-19 vaccines and used as specified in the marketing authorization may now be conducted as a noninterventional trial if these measures each pose only a minimal risk and minimal burden to the subject. These non-interventional tests must be reported to the Paul-Ehrlich-Institut (§ 4 para. 7a sentence 2 MedBVSV). The notification should be made by email to firstname.lastname@example.org.
The information on the website of the Paul-Ehrlich-Institut on the notification of post-marketing surveillance studies should be followed.Supplementary recommendations of BfArM and PEI to the European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (Unofficial, informal Translation of the German Text)