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The European Medicines Agency (EMA) has requested more information on the vaccine, the company said on Monday. So far, the company was hoping to get approval for its so-called inactivated vaccine in April. “We are disappointed that the EMA has so far not considered our requests sufficient,” said Valneva boss Thomas Lingelbach. “We remain fully committed to working with regulatory authorities for product approval.”
EMA’s Committee for Medicinal Products for Human Use sent another list of questions to the company, Valneva said. These include requests for additional data and further justifications for conditional market approval for the vaccine candidate. The company intends to respond to requests in the coming days. If regulators accept the new information, Valneva expects conditional market approval later this quarter.
Earlier this month, the UK approved Valneva’s Covid-19 vaccine. It was the first European country to give the green light to the inactivated vaccine. The UK Medicines Agency (MHRA) has approved it for use in adults between the ages of 18 and 50. The technology used by Valneva has been used for decades, for example in vaccines against polio, influenza and hepatitis A. The Valneva vaccine is based on the virus in its natural form, which is chemically inactivated and cannot multiply in the body of the vaccinated person. Upon contact, the body reacts with the same immune response as the active coronavirus and forms antibodies.
As a result, Valneva shares on the Paris stock exchange fell by 15.96% to EUR 12.95.
Vienna / Paris (Reuters)
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