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|Articles|May 7, 2021
EMA’s CHMP Starts Rolling Review of Inactivated COVID-19 Vaccine
Author(s)BioPharm International Editors
The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.
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The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.
According to a May 4, 2021 press release, CHMP’s decision to start the rolling review has been based on preliminary results from laboratory studies and clinical studies, which suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2. All data will be evaluated by EMA as it becomes available on a rolling basis and will continue until sufficient evidence is available for a formal marketing authorization application.
Compliance of Vero Cell will be assessed by EMA, according to the usual European Union standards for effectiveness, safety, and quality. Further communications will be published by EMA when the marketing authorization application for the vaccine has been submitted.
The EU applicant for the medicine is Life’On S.r.l.
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