Application Submitted for Conditional Marketing Authorisation of the Protein-based COVID-19 Vaccine Candidate Vidprevtyn
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA), on which the Paul-Ehrlich-Institut is represented, started the evaluation procedure on 30 March 2022 for the conditional marketing authorisation application submitted by Sanofi Pasteur for the protein-based SARS-CoV-2 vaccine Vidprevtyn. The EMA began its rolling review on 20 July 2021.
Vidprevtyn is – following the already authorised COVID-19 vaccine Nuvaxovid from Novavax – now the second protein-based COVID-19 vaccine candidate to start the EU authorisation procedure. It contains a cell culture-produced version of the SARS-CoV-2 spike protein and AS03, an adjuvant.
The evaluation will be completed using data from clinical trials with more than 10,000 adult volunteers in the US, Latin America, Africa, and Asia who had not previously received a COVID-19 vaccine or been infected with SARS-CoV-2. They received two doses of the protein-based vaccine candidate, each containing 10 μg of antigen, at an interval of 21 days. The antigen contained in the vaccine corresponds to the spike protein of the D614 wild-type virus.