EMA delays Valneva vaccine approval

The CHMP’s action puts pressure on the French-Austrian vaccine developer, which wanted to market the vaccine from April on as the UK has already ordered the vaccine. The advisory committee’s request for additional data is likely to further delay market authorisation. While the British regulatory authority MHRA granted conditional approval to VLA2001 that was Phase III-tested at 26 sites in the UK, the CHMP’s list of questions is a setback for Valneva in the rolling procedure with the EMA. In it, additional data and a supplementary justification for a conditional marketing authorisation are demanded.

Thomas Lingelbach, Chief Executive Officer of Valneva, is correspondingly dissatisfied: "We are disappointed that the EMA has not yet considered our applications as sufficient. We remain fully committed to working with regulators towards product approval. We continue to receive messages every day from people who want such a more traditional vaccine approach."

The data from the pivotal Phase III head-to-head trial with AstraZeneca’s EMA-approved vaccine AZD1222 provided that VLA2001 induced higher neutralising antibody levels and had a significantly better tolerability profile.  The GMT was significantly higher in participants aged 30 years and older, at 803.5 versus 576.6, after AZD1222 administration. Seroconversion was achieved in more than 95% of participants in both groups. VLA2001 also produced a good T-cell response. In an assay that examined the release of interferon gamma after exposure to the viral components, 74.3 % of the cells responded to the spike protein, 45.9 % to the nucleoprotein and 20.3 % to the membrane protein. Since the last two proteins are missing in AZD1222 (and all other approved vaccines), VLA2001 could achieve a broader immune response.This was sufficient for the UK MHRA to grant conditional approval and confirm that VLA2001 meets the required safety, quality and efficacy standards. The EMA still sees a need for further enquiries. Valneva  hopes to answerquickly enough so that a conditional marketing authorisation can still be granted in Q2/2022.

In order to prepare itself financially, Valneva also declared that it had reached agreements on debt financing amounting to a further $40m on top of the existing $60mwith funds managed by the US investment companies Deerfield Management Company and OrbiMed.