Fierce Biotech In the world of clinical trials, missing the primary endpoint of a pivotal trial typically spells real trouble for a drug program. But for Valneva CEO Thomas Lingelbach, the regulatory future of the company’s Pfizer-partnered Lyme disease vaccine, VLA15, is very much “a matter of negotiation.”
“It’s a matter of bringing all the arguments together that could allow them to show a certain degree of flexibility,” Lingelbach said of the FDA in an interview with Fierce on the sidelines of the World Vaccine Congress Washington 2026.
The phase 3 Valor trial technically failed to meet its primary endpoint, which measured the rate of Lyme disease among participants 28 days after they received the fourth dose of either the vaccine or placebo. In the study, the lower bound of the 95% confidence interval dipped below the predetermined threshold of 20%, causing the miss. But from an efficacy standpoint, the six-valent shot, also dubbed PF-07307405, showed a 73.2% improvement compared with placebo at that point.