(BFM Bourse) – While the UK medicines agency, in addition to that of the Kingdom of Bahrain, has issued the marketing authorization for the Covid vaccine VLA2001, the European agency has asked Valneva additional data. The delay before obtaining an authorization could range from a few days to a few months, an analyst estimates.
Within days of obtaining the marketing authorization from the British MHRA – an honorary success as the government of Boris Johnson gave up acquiring it – Nantes biotech Valneva fails to obtain the green light from the European authority that it hoped to obtain by the end of April (with potentially millions of doses to be dispensed). A disappointment for the company and obviously for its shareholders (including the French state through the CDC and its 9% stake). At around 9:30 am, the stock fell 13.14% to EUR 13.38 after this announcement, dropping to its lowest since March.
Following the meeting of the members of the Committee for Medicinal Products for Human Use (CHMP, responsible for establishing the scientific opinion of the agency) of the European Medicines Agency, Valneva A new list of questions related to your marketing application for the VLA2001 vaccine has been sent. This list includes requests for submission of new data and further justifications for a conditional marketing authorization, indicates the company resulting from the merger of the French Vivalis and the Austrian Intercell.
Valneva intends to respond “in the next few days” and believes that if the CHMP accepts the items sent by Valnevaa marketing authorization could still take place during this quarter, ie by June.
“We are disappointed that the EMA has not deemed our requests sufficient to date. We remain fully committed to working together with the regulatory authorities for the marketing authorization of the product. VLA2001 is the only inactivated vaccine candidate. against COVID-19 in Europe and we continue to receive messages every day from people seeking a more traditional vaccination approach, “said CEO Thomas Lingelbach, referring to the inactivated and adjuvanted virus technology used for this product.
In the eyes of biotechnology, its inactivated vaccine “meets the criteria for obtaining a conditional marketing authorization, including with regards to the benefit / risk ratio” and its teams remain focused on obtaining a conditional release authorization. in Europe.
Maintaining his stock market ‘neutral’ opinion, Oddo BHF underlines the difficulty of understanding the future direction of the discussions due to the lack of visibility on the content of the CHMP requests. “We estimate that depending on the data requested, the delay can vary from a few days (provision of clinical data already available) to a few months (start of a new clinical study)”, indicates the design office.
Guillaume Bayre – © 2022 BFM Stock Exchange