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Tag: paul

Paul-Ehrlich-Institut – Another Clinical Trial of a COVID-19 Vaccine authorised in Germany

Spike-Protein on SARS-CoV-2 (Source: S.Myshkovsky/photodisc/Gettyimages)

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, has authorised another clinical trial of a vaccine against COVID-19 in Germany. The intensive preliminary scientific advice of the medicines developer CureVac, and the prioritisation of the regulatory activities at the Paul-Ehrlich-Institut for vaccines and biomedicines against COVID-19 have made it possible to complete the authorisation procedure […]

RECOVER – the Paul-Ehrlich-Institut Authorises another COVID-19 Therapy Study with Reconvalescent Plasma

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines has authorised the second clinical study with COVID-19 reconvalescent plasma (RECOVER) in Germany. The purpose of such clinical trials is to gain insights into the safety and efficacy of COVID-19 reconvalescent plasma in the treatment of serious COVID-19 infections. Patients to be treated include old and high-risk […]

Warning against the Off label Use of BCG Products

In Germany, immunostimulatory products on the basis of bacteria preparations derived from the Bacillus Calmette-Guérin (BCG) mycobacterial strain are authorised for the treatment of urinary bladder carcinoma. The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines has issued a warning that the BCG products available in pharmacies are not authorised for the treatment or prevention of […]

Paul-Ehrlich Institut : First Clinical Trial of a COVID-19 Vaccine Authorised in Germany

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, has authorised the first clinical trial of a vaccine against COVID-19 in Germany. Spike-Protein SARS-CoV-2 (Source: Viaframe/Corbis/GettyImages) The authorisation of this trial is the result of a careful assessment of the potential risk/benefit profile of the vaccine candidate. Based on extensive scientific advice to the medicine developer, […]

Paul-Ehrlich-Institut Approves First COVID-19 Therapy Study with Convalescent Plasma

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, has granted approval for the first clinical trial with COVID-19 convalescent plasma (CAPSID) in Germany. The aim of the clinical trial is to gain insights into the efficacy and safety of COVID-19 convalescent plasma in the treatment of severe COVID-19 diseases. The ethics committee has also issued […]