Valneva's Omicron splash masks a delay in Europe

Valneva’s announcement yesterday on the performance of its Covid vaccine candidate VLA2001 against the Omicron variant was light on details, but managed to send the group’s stock up 45%. Still, all is not completely rosy: the EMA is awaiting more data on VLA2001, its head of biological health threats and vaccines strategy, Dr Marco Cavaleri, disclosed during a press briefing on Tuesday. He added that the agency hoped to progress its rolling review, which began in December, “in the coming months”, but would not provide further timelines. Full data have yet to emerge from the phase 3 Cov-Compare study, which Valneva toplined as positive in October; however, these will not elucidate VLA2001’s effect on Covid outcomes, as the trial merely tested immunogenicity versus Astrazeneca’s Vaxzevria. Yesterday’s results, though far from comprehensive, make VLA2001 look less than stellar against Omicron: of 30 serum samples from people who had received three doses of VLA2001, 100% presented neutralising antibodies against the original virus and Delta variant, but this fell to 87% against Omicron. The mean reduction in neutralisation versus the original virus was 2.7-fold for Delta and 16.7-fold for Omicron. Valneva shares fell 19% this morning, but the group is still worth $2bn.