The European Medicines Agency (EMA) requested this Monday, April 25, new data from the pharmaceutical group Valneva on its anti-Covid vaccine, before possible authorization.
The EMA sent the Franco-Austrian laboratory a list of questions including “additional justifications”, the agency said in a press release published on Monday.
The vaccine developed by Valneva has already been approved by the UK and hoped to obtain authorization before the end of June.
“We are disappointed that the EMA has not considered our submissions sufficient to date,” said Thomas Lingelbach, chairman of Valneva’s management board. We remain fully committed to working jointly with the regulatory authorities towards the marketing authorization of the product”.
A negative impact on the stock market
The vaccine candidate is different from other competitors already approved. It does not use messenger RNA (Pfizer/BioNTech, Moderna), is not viral vectored (AstraZeneca, Johnson & Johnson) and is based on an inactivated virus.
“We continue to receive messages every day from people looking for a more traditional vaccine approach,” said Thomas Lingelbach.
Following this announcement, the action of the Franco-Austrian laboratory tumbled 14.24% to 13.19 euros.
Despite this setback, the group still hopes to stick to its timetable in the event of approval by the health authorities.