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The company announced on Thursday that the European Medicines Agency (EMA) had accepted the application for approval of the vaccine candidate. “The acceptance of the EMA’s application for approval is an important step on the road to product approval,” said CEO Thomas Lingelbach.
From the so-called continuous test procedure, we move to a formal test procedure by the Committee for Medicinal Products for Human Use (CHMP). If the conditional marketing authorization application is accepted, Valneva expects a positive opinion from the CHMP in June. The European Commission will then review the recommendation and make a final decision on the request for approval. If the European Commission gives the green light, the marketing authorization would be valid in all Member States of the European Union as well as in Iceland, Liechtenstein and Norway.
“We remain fully committed to working with regulators, European member states and the European Commission to bring more traditional and proven Covid-19 vaccine technology to the people of Europe,” Lingelbach said. The technology used by Valneva has been used for decades, for example in vaccines against poliomyelitis, influenza and hepatitis A.
In Paris, Valneva shares rose 16.87% to 11.71 euros.
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