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CureVac Initiates Rolling Submission for COVID-19 Vaccine with Swissmedic

CureVac Initiates Rolling Submission for COVID-19 Vaccine with Swissmedic

CureVac has filed for authorization of its two-dose messenger RNA-based COVID-19 vaccine, CVnCoV, by Switzerland’s pharmaceuticals regulator, Swissmedic.

CureVac’s vaccine is currently being evaluated in a phase 2b/3 study in Latin America and Europe enrolling 40,000 participants. Results from that study, which got under way in December, will also be used to support a rolling submission to the European Medicines Agency, which began in February. CureVac says it expects authorization in the EU during this quarter.

In addition to its pact with GlaxoSmithKline (GSK), CureVac has also partnered with Novartis and Bayer to potentially manufacture hundreds of millions of doses of CVnCoV.

April 20, 2021

https://www.fdanews.com/

April 20, 2021 / Pharma News
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