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.

The ups and downs of Valneva's investigational Covid vaccine
Date Event
Jan 19, 2022 Company releases lab data on VLA2001 vs Omicron; shares rise 45%
Jan 18, 2022 EMA discloses that it is waiting for more data on VLA2001
Dec 16, 2021 Valneva releases "positive" homologous booster data from VLA2001's phase 1/2 trial
Dec 8, 2021 Valneva signs contract with Bahrain for 1m doses of VLA2001
Dec 2, 2021 UK Cov-Boost study, of 7 vaccines, shows disappointing results with VLA2001 
Dec 2, 2021 EMA begins rolling review of VLA2001
Nov 23, 2021 Valneva signs contract with EMA for up to 60m doses of VLA2001 over 2yrs
Oct 18, 2021 Valneva reports topline results from ph3 Cov-Compare trial, showing superior immunogenicity vs Astra's Vaxzevria
Sep 13, 2021 UK cancels contract for 100m doses of VLA2001
Aug 23, 2021 Valneva starts rolling submission with UK's MHRA
Aug 11, 2021 Valneva starts ph3 VLA2001-304 study in elderly 
May 6, 2021 Valneva prices US IPO
Apr 21, 2021 Valneva starts Cov-Compare study
Apr 20, 2021 Valneva deprioritises discussions with EMA over VLA2001 supply
Apr 6, 2021 Valneva reports ph1/2 data with VLA2001
Feb 1, 2021 UK government exercises option for a further 40m doses of VLA2001 in 2022
Sep 14, 2020 Valneva signs contract with UK for initial 60m doses of VLA2001
Source: company releases, The Lancet & EMA press briefing.

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