Val­ne­va, Pfiz­er de­lay their Ly­me dis­ease vac­cine sub­mis­sion to 2026

Val­ne­va said Pfiz­er now aims to sub­mit their part­nered Ly­me dis­ease vac­cine can­di­date to US and Eu­ro­pean reg­u­la­tors in 2026, rather than 2025, pend­ing Phase III suc­cess.

Val­ne­va made the up­date in its quar­ter­ly earn­ings Thurs­day, and the French vac­cine mak­er said Pfiz­er would pay for in­cre­men­tal study ex­e­cu­tion costs that re­sult from ad­di­tion­al en­roll­ment. The US Big Phar­ma pulled a cou­ple thou­sand par­tic­i­pants from the study ear­li­er this year af­ter po­ten­tial good clin­i­cal prac­tice vi­o­la­tions, which have yet to be dis­closed, were cit­ed at a third-par­ty con­tract re­search start­up that ran mul­ti­ple sites for the tri­al.

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