(BFM Bourse) – The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the marketing authorization of Valneva’s inactivated whole virus vaccine candidate against Covid-19, a recommendation that is still followed in practice administrative green light. Intending to convince some of those resistant to mRNA vaccines, the Nantes biotech hopes that this will encourage the Commission to place a sufficient order to make the VLA2001 program viable.
The experimental vaccine VLA2001 is about to become an approved product – but its marketing still depends on a sufficient volume of orders from the European Commission, which did not seem certain ten days ago.
The vaccine specialist said on Thursday that the Committee for Medicinal Products for Human Use (CHMP, responsible for the scientific, medical and regulatory part) of the European Medicines Agency (EMA) had recommended marketing authorization ( MA) in Europe of its inactivated and adjuvanted whole virus vaccine as a primary vaccination, at this stage in an adult population (18 to 50 years old).
The European Commission (EC) will examine the CHMP recommendation and a formal decision on the VLA2001 marketing application in Europe is expected “soon” (in practice, the agency systematically follows the CHMP opinion). VLA2001 would thus become the first vaccine against Covid-19 to receive standard type marketing authorization in the European Union, the vaccines authorized during the last year such as Comirnaty (BioNTech/Pfizer) or Spikevax ( Moderna) that received emergency clearance.
“Solid” data
The CHMP concluded by consensus after a thorough assessment “that the data on the vaccine were strong and met European Union criteria for efficacy, safety and quality”. A summary of the CHMP session called “meeting highlights” will be available on Friday, while the full minutes are usually not available for a month and a half.
“We are delighted that the CHMP has recommended VLA2001, the only inactivated vaccine candidate against Covid-19 in Europe, for standard type marketing authorization and we now look forward to receiving this authorization from the Commission. to personally thank all those who have supported us in this effort, as well as all Valneva employees for their diligent work”, underlined the general manager of the Franco-Austrian firm, Thomas Lingelbach. “We hope that the European Commission and its Member States will recognize the potential benefits of an inactivated vaccine and place a sizeable order as we have evidence that Europeans are looking for more traditional vaccine technology. We want to contribute more to public health by Europe by offering a new option to the 15% of Europeans over the age of 18 who are not yet vaccinated”, he stressed again.
Once granted by the European Commission, the marketing authorization would be valid in all Member States of the European Union, as well as in Iceland, Liechtenstein and Norway.
The positive opinion from the EMA’s CHMP follows a conditional marketing authorization in the United Kingdom, granted in April 2022 (but not followed by an order following the cancellation of the contract placed by the government at the end of 2020), to an emergency use authorization in the United Arab Emirates in May 2022 and another also in emergency in Bahrain in March 2022.
Suspended Wednesday evening pending the committee’s response, Valneva’s trading resumed Thursday at 4:30 p.m., the action taking off 13.5% to 13.51 euros around 4:50 p.m.
Guillaume Bayre – ©2022 BFM Bourse
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