(BFM Bourse) – Valneva’s share price falls by more than 20% as the Nantes biotech raises the alarm about the volumes of its Covid vaccine that the European Union would consider ordering in the event of approval . Much too low as it stands, these volumes would not allow the VLA2001 program to continue.
A few days before the meeting of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which could on this occasion deliver its opinion with a view to the approval of Valneva’s vaccine against Covid-19, the sustainability of this program now appears in play even in the event of a green light from the health authorities. According to current feedback from the European Union, the independent vaccine specialist is concerned that it will not obtain enough orders to make this program viable.
After receiving the notice of intent from the European Commission to terminate the previously entered into supply agreement due to the lead time caused by the extended approval process, Valneva submitted a remediation plan which is under discussion with the Commission and the participating Member States.
Some Member States have confirmed their interest in including an inactivated whole virus vaccine solution. However, the preliminary volume indications received from the Commission “would not be sufficient to ensure the sustainability of Valneva’s Covid-19 vaccine program”. It would also hamper future development of the program beyond the current product profile, the firm says.
If these indications were confirmed, Valneva would not be able to conclude an amendment to the supply agreement for a reduction in the volumes ordered, and the European Commission would probably terminate the agreement. As a result, Europeans would not have access to the inactivated VLA2001 vaccine.
Without being able to disclose the volumes currently mentioned by Europe, the CEO of Valneva stressed on BFM Business that the current indications on order intentions were “substantially” lower than 60 million doses, including 24 million to be delivered this year, envisaged in the initial agreement, while the EU has also ordered 4 billion vaccines.
“Significant interest from unvaccinated people”
“We hope that the European Commission and the Member States will continue to evaluate the potential advantages of an inactivated vaccine”, underlined the director general Thomas Lingelbach, VLA2001 being currently the only inactivated and adjuvanted vaccine candidate against Covid-19 potentially available in France. Europe. “New information demonstrates that hybrid immunity – vaccination and natural infection combined – increases protection against the development of a severe form of Covid-19 caused by different variants of concern, and our inactivated vaccine is the closest to that. ‘a natural infection because it exposes vaccinated people to the whole inactivated virus of SARS-CoV-2”, underlined the co-leader of the group.
“In addition, market research conducted in six European countries has shown significant interest from unvaccinated people for an inactivated vaccine against Covid-19. We also continue to receive messages from people looking for a more traditional vaccine technology. We hope to receive a significant enough order volume to be able to further contribute to public health in Europe.”
In parallel to discussions with the Commission, the regulatory process with the European Medicines Agency is therefore continuing with a final CHMP vote expected during the week of June 21, 2022. Valneva also continues to work with regulatory agencies outside of the European Union for possible additional marketing authorizations and purchasing agreements.
The threat weighing on the future of Valneva’s vaccine leads to a fall of 23.77% in the price to 7.966 euros, a low for nearly a year and a half corresponding to a capitalization of 60 million euros.
“If the company cannot agree on sufficient volumes or the vaccine does not obtain its MA [autorisation de mise sur le marché NDLR]the 2022 sales targets should be revised significantly downwards”, indicate the health analysts of Oddo BHF. The research office estimated the potential sales attached to the contract with Europe at 220 million euros in 2022, or 65% of turnover.Oddo BHF specifies that without the marketing of VLA2001, its estimate of the fair value of the share would drop from 16.3 to 9 euros.
Guillaume Bayre – ©2022 BFM Bourse
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