EMA Starts Rolling Review of Sanofi’s COVID-19 Vaccine

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine—based on preliminary non-clinical and early clinical results. According to a July 20, 2021 press release, the early trial data suggest that Sanofi’s vaccine triggers the production of antibodies that target SARS-CoV-2 and may help protect against the disease.

Rolling reviews are employed by EMA to accelerate assessment of promising drug candidates during public health emergencies. All data on Vidprevtyn will be evaluated by EMA as soon as they become available, so that a decision on whether the vaccine benefits outweigh the risks can be made.

The rolling review process will be performed until sufficient evidence is acquired for a formal marketing authorization application. EMA has specified that further communication will be published once a formal application for marketing authorization has been submitted.

Source: EMA