A few weeks ago, HIPRA received the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the authorisation for commercialisation in the European Union of BIMERVAX®, the vaccine against COVID-19 developed by the biotechnology pharmaceutical company.
The Clínic-IDIBAPS has participated in all phases of the human clinical trials that have been conducted. Phase I/IIa of the clinical trials was co-led by a team from the IDIBGi, from Girona, headed by Rafel Ramos, and by Àlex Soriano, head of the Infectious Diseases Service at the Hospital Clínic Barcelona and head of the IDIBAPS nosocomial infections group and Lorna Leal, a specialist from the Infectious Diseases Service and IDIBAPS researcher.
It has also been worked on by the Clinical Trials Unit (CTU) of the Clinical Pharmacology Service, whose aim is to provide support for the ethical, methodological, regulatory, and logistic aspects of clinical trials with medicines or advanced therapies promoted by researchers from the institution. The study was evaluated by the Ethics with Medicines Committee (CEIm) at the Hospital Clínic Barcelona, and its approval was the reference point for the subsequent clinical trials. After the initial phases, the clinical trial has continued as a multi-centre study, with the continuing involvement of the Clínic-IDIBAPS.
Montserrat Plana, an IDIBAPS researcher, and her team, have conducted part of the cellular immunity analyses among the volunteers who received the vaccine. The Biobank has participated in the design of the samples collection circuits and has produced the protocols for the processing of samples and cell isolation. It has also designed the kits containing material for the collection and processing of samples from volunteers; it has processed the samples originating from the Clínic and also, at the Freezing and Cryopreservation Service, it has centralised the custody of the processed samples.