The company would welcome the opportunity to provide the vaccine for use in Britain, but so far the government has not made such a decision, the spokesperson added. In February, the company said it had received a list of questions from the EMA.Ī spokesperson said in an email that Valneva was confident that its response to the first set of CHMP questions would be enough for the EMA to conclude their assessment, particularly after that data was deemed sufficient by the British drug regulator. Getting the shot into arms has proved somewhat difficult for Valneva - this is not the first time it has been asked to provide additional information. The shot is seen by some as having the potential to win over people wary of some vaccines which use newer mRNA technology.Īnother advantage is that the vaccine can be stored at similar temperatures to those in a domestic fridge. The approach involves growing the virus in a lab, then rendering it completely inactive so it cannot infect cells or replicate in the body, but can still trigger an immune response. The whole-virus inactivated COVID-19 vaccine developed by Valneva relies on technology that has been used for decades, for instance in some shots against polio, influenza and hepatitis. Valneva's share price slumped about 15.5%, putting the stock on track for its worst day since Jan. We remain fully committed and dedicated to working jointly with the regulators towards a product approval," Valneva CEO Thomas Lingelbach said in a statement. "We are disappointed that the EMA has not considered our submissions sufficient to date. Valneva said the EMA Committee for Medicinal Products for Human Use (CHMP) had a fresh list of questions, including requests for additional data and for further justification of a conditional marketing authorisation for the vaccine. The latest EMA setback comes after Britain earlier this month cleared the use of Valneva's vaccine, becoming the first European country to give its shot the green light. LONDON/PARIS, April 25 (Reuters) - French drugmaker Valneva (VLS.PA) said on Monday that the European Medicines Agency (EMA) had asked for more data on its COVID-19 vaccine, precipitating a sharp fall in its shares.
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