Pfizer Lyme disease vaccine fails trial, company to seek FDA approval
CNBC • • general
Key Points:
- Pfizer plans to seek regulatory approval for its Lyme disease vaccine candidate despite the shot failing to meet the statistical goal in a late-stage trial due to insufficient Lyme disease cases among participants.
- The vaccine showed over 70% efficacy in reducing infection rates compared to placebo, which Pfizer considers strong enough to support regulatory submission.
- Lyme disease affects about half a million Americans annually, but no human vaccine is currently available; Pfizer's candidate would be the first new vaccine for Lyme disease since LYMErix was withdrawn in the early 2000s.
- The Phase 3 trial faced challenges, including dropping half the participants due to quality concerns with a third-party clinical trial operator, reducing the study size from 18,000 to about 9,400.
- Pfizer and partner Valneva reported no safety concerns in the trial, and the vaccine requires a series of three doses in the first year plus a booster the following year, aiming to block bacterial transmission from ticks to humans.
