Press release
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Valneva Reports Positive Phase 3 Results for Inactivated , Adjuvanted COVID - 19 Vaccine Candidate VLA2001 valneva.com/press-release/valne va - reports - positive - phase - 3 - results - for - inactivated - adjuvanted - covid - 19 - vaccine candidate - vla2001 • VLA2001 successfully met both co - primary endpoints o Superior neutralizing antibody titer levels compared to active comparator vaccine , AstraZeneca's AZD1222 ( ChAdOx1 - S ) • Neutralizing antibody seroconversion rate above 95 % • VLA2001 induced broad T - cell responses with antigen - specific IFN gamma - producing T - cells against the S , M and N proteins . • VLA2001 was well tolerated , demonstrating a statistically significant better tolerability profile compared to active comparator vaccine Saint Herblain ( France ) , October 18 , 2021 – Valneva SE ( Nasdaq : VALN ; Euronext Paris : VLA ) , a specialty vaccine company , today announced positive topline results from the Phase 3 pivotal trial Cov - Compare of its inactivated , adjuvanted COVID - 19 vaccine candidate , VLA2001 . Valneva’s Chief Executive Officer , Thomas Lingelbach , and the trial's Chief Investigator , Adam Finn , Professor of Paediatrics at the University of Bristol , will comment on the results in a live webcast beginning at 3 p.m. CET today . Please refer to this link : https://edge.media-server.com/mmc/p/3zmb7nnp . The pivotal Phase 3 , Cov - Compare trial recruited a total of 4,012 participants aged 18 years and older across 26 trial sites in the United Kingdom . The trial met its co - primary endpoints : VLA2001 demonstrated superiority against AZD1222 ( ChAdOx1 - S ) , in terms of geometric mean titer for neutralization antibodies ( GMT ratio = 1.39 , p < 0.0001 ) , ( VLA2001 GMT 803.5 ( 95 % CI : 748.48 , 862.59 ) ) , ( AZD1222 ( ChAdOx1 - S ) GMT 576.6 ( 95 % CI 543.6 , 611.7 ) ) , as well as non - inferiority in terms of seroconversion rates ( SCR above 95 % in both treatment groups ) at two weeks after the second vaccination ( i.e. Day 43 ) in adults aged 30 years and older . T - cell responses analyzed in a sub - set of participants showed that VLA2001 induced broad antigen - specific IFN - gamma producing T - cells reactive against the S- ( 74.3 % ) , N ( 45.9 % ) and M- ( 20.3 % ) protein . VLA2001 was generally well tolerated . The tolerability profile of VLA2001 was significantly more favorable compared to the active comparator vaccine . Participants 30 years and older reported significantly fewer solicited adverse events up to seven days after vaccination , both with regards to injection site reactions ( 73.2 % VLA2001 vs. 91.1 % AZD1222 ( ChAdOx1 - S ) , p < 0.0001 ) and systemic reactions ( 70.2 % VLA2001 vs. 91.1 % AZD1222 ( ChAdOx1 - S ) , p < 0.0001 ) . No unsolicited treatment - related serious adverse events ( SAE ) have been reported . Less than 1 % reported an adverse event of special interest in both treatment groups . Participants in the younger age group vaccinated with VLA2001 showed an overall safety profile comparable to the older age group . 1/4