The European Medicines Agency (EMA for its acronym in English) announced on Monday that it has begun the continuous review of Vidprevtyn, a vaccine against covid-19 developed by the French laboratory Sanofi Pasteur.
The decision is based on “preliminary results of laboratory studies (non-clinical data) and the first clinical studies in adults”, which suggest “that the vaccine triggers the production of antibodies directed against SARS-CoV-2, the virus that causes covid-19, ”the EMA said in a statement.
The Vidprevtyn vaccine is made from proteins that contain a laboratory-grown version of the spike protein found on the surface of SARS-CoV-2. It contains an immune adjuvant, a substance that helps strengthen immune responses.
The EMA does not follow a general review schedule with fixed dates, although the ongoing review allows analysis work to be carried out to expedite the study of a possible license in the future, when it has been verified that the Vidprevtyn treatment meets the efficacy standards. safety and quality.
The European regulatory body explained that “it will evaluate the data as it becomes available to decide whether the benefits outweigh the risks” and that the process will continue until “sufficient evidence is available for a formal application for marketing authorization”, which it must be approved by the European Commission.
The ongoing review Vidprevtyn will undergo is the same as the four vaccines already authorized for inoculation in the European Union: those developed by BioNTech and Pfizer, Moderna, AstraZeneca and Janssen.
Other vaccines that are still in this ongoing review process are the one promoted by the American pharmaceutical Eli Lilly, the Chinese Sinovac and the Russian Sputnik V, as well as the monoclonal antibody regdanvimab (CT-P59), developed by Celltrion, and the combination of REGN-COV2 antibodies (casirivimab / imdevimab), from the pharmaceutical company Regeneron-Roche.