Pfizer pushes ahead with Lyme vaccine despite late-stage trial miss
Pfizer intends to seek FDA approval for its Lyme disease vaccine candidate even after a late-stage trial failed to meet statistical goals due to too few Lyme cases; the company says efficacy exceeded 70% in vaccine recipients versus placebo, which they consider strong enough to move forward. Partner Valneva projects up to $1 billion in peak annual sales. The Phase 3 study started with about 18,000 participants but was reduced to roughly 9,400 due to site-quality issues, and Pfizer reports no safety concerns; the vaccine requires three initial doses followed by a booster and targets the outer surface protein A of the bacteria.
