EMA begins rolling review of Sanofi Pasteur COVID vaccine
The European Medicines Agency (EMA) has taken a fifth COVID-19 vaccine candidate into its rolling review scheme, evaluating data as they become available to speed a regulatory decision amid the ongoing public health emergency of the COVID-19 pandemic.EMA’s decision to evaluate Sanofi Pasteur’s Vicprevtyn vaccine by rolling review is based on non-clinical data and early clinical studies “which suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease,” according to EMA’s Tuesday announcement.
The adjuvanted protein-based vaccine presents a synthetic version of the SARS-CoV-2 virus’ spike protein to prompt an antibody response after vaccination.
Vicprevtyn joins vaccine candidates manufactured by Sinovac, CureVac, Novavax, and Russia’s Gamaleya National Center of Epidemiology and Microbiology in being evaluated by EMA’s human medicines committee (CHMP) via the rolling review process. (RELATED: Kineret under review by EMA for some COVID patients, Regulatory Focus 19 July 2021)
“Normally, all data on a medicine or vaccine’s effectiveness, safety and quality and all required documents must be ready at the start of the evaluation in a formal application for marketing authorization,” explained EMA in the announcement. “In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available from ongoing studies.” CHMP notifies the applicant when it deems that sufficient data have been provided to support a formal application for a marketing authorization or conditional marketing authorization.
No other vaccine candidates are currently being considered for marketing authorization applications. Four vaccines currently hold conditional marketing authorization in the EU: Comirnaty, the mRNA vaccine marketed by Pfizer/BioNTech; Moderna’s mRNA vaccine Spikevax; Janssen’s one-dose adenovirus vaccine; and the adenovirus vaccine Vaxzevria, marketed by AstraZeneca.
EMA
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