Vaccines
Pfizer-Valneva Lyme vaccine showed efficacy but missed primary endpoint
LB6V showed 73.2% efficacy 28 days after dose four, but its confidence interval fell below the trial’s required threshold.
Pfizer and Valneva’s investigational Lyme disease vaccine showed efficacy in a phase 3 trial but missed its primary endpoint, according to results presented at IDWeek. The vaccine, called LB6V, was 73.2% efficacious 28 days after the fourth dose compared with placebo (95% CI, 15.8%-93.5%). It was 74.8% efficacious starting 1 day after the fourth dose, Healio reported.
The lower bound of the confidence interval fell below the required 20% threshold. Researcher Paul G. Auwaerter attributed the miss to a limited number of cases. The trial enrolled nearly 10,000 participants aged 5 years and older, and 8,011 completed it. Participants received four doses of LB6V or saline placebo.
Pfizer said in March it would pursue regulatory approval, Healio reported. Valneva said last year that Pfizer expected a launch in the U.S. and Europe in the second half of 2027, pending approval.
