Valneva share plummeting: Setback for Valneva inactivated vaccine – EU authority demands more information

The European Medicines Agency (EMA) has requested more information about the vaccine, the company said on Monday. So far, the company hoped to get approval for its so-called inactivated vaccine in April. “We are disappointed that the EMA has so far not considered our submissions to be sufficient,” said Valneva boss Thomas Lingelbach. “We remain fully committed to working with regulators towards product approval.”

EMA’s Committee for Medicinal Products for Human Use has 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 the inquiries 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 for 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. The body responds to contact with the same immune response as with active coronavirus and forms antibodies.

On the Paris stock exchange, Valneva’s shares then temporarily collapsed by 14.76 percent to EUR 13.135 and are heading for their biggest daily loss since the beginning of January.

Vienna/Paris (Reuters)

Image sources: mundissima / Shutterstock.com