Pfizer and Valneva's experimental Lyme vaccine (LB6V/PF-07307405) demonstrated 73.2% efficacy 28 days after the final dose but failed to meet the primary endpoint when the 95% confidence interval lower bound was only 15.8%, below the required 20% threshold 1 The vaccine showed 74.8% efficacy one day after the fourth dose, with the confidence interval lower bound exceeding 20% in this secondary pre-specified analysis 1 2 The companies blamed the primary endpoint miss on fewer than anticipated Lyme disease cases being accrued during the VALOR study, which enrolled 9,437 individuals aged 5 years and older across the U.S., Canada, and Europe 1 Despite missing the primary endpoint, Pfizer stated it is confident in the vaccine's potential and plans to submit it to regulatory authorities for approval 1 Lyme disease affects approximately 476,000 people annually in the U.S. and 129,000 in Europe, with no vaccines currently approved in the U.S.; GSK withdrew its Lyme vaccine (LYM...
- Get link
- X
- Other Apps