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yesterday

Pfizer, Valneva Report About 75% Efficacy for Lyme Vaccine, Plan FDA Filing

The late-stage study's second planned analysis met the efficacy bar after an initial readout fell short due to few Lyme cases.

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Nantucket, MA -- 06/07/16 -- Hikers walk past a warning sign about ticks and Lyme Disease as they enter the "Sanford Farm, Ram Pasture, The Woods, Barn and Back Trail" hiking area on June 7, 2016, in Nantucket, Massachusetts. A view grassy rolling sand dunes, and marshy area is seen along the soft sand road leading to Eel point on June 6, 2016, in Nantucket, Massachusetts. This area consists of rolling grassy sand dunes, as well as several shallow saltwater lagoons. Ticks that carry Lyme Disease are present island-wide, and are commonly found in sites where the moisture is high, including woods, marshy areas, high grass and along the brushy edges of fields. The area traverses a former farm and grazing area, and includes grassland, shrubland, a pine grove, and a glacially formed freshwater pond. (Kayana Szymczak for STAT)
A Pfizer logo is shown at a research facility in the La Jolla neighborhood of San Diego, California, U.S., September 30, 2025. REUTERS/Mike Blake
Lyme disease is the most common illness transmitted by ticks

Overview

  • The candidate, PF-07307405, showed 73.2% efficacy from 28 days after the fourth dose in an initial analysis that missed its primary endpoint because too few cases accrued.
  • A pre-specified second analysis found 74.8% efficacy, which Pfizer said supports submissions to U.S. regulators.
  • The companies reported no safety concerns in the trial.
  • The dosing schedule consists of three shots in the first year followed by a booster in the second year.
  • There has been no approved human Lyme vaccine since GSK withdrew Lymerix in 2002, and the disease leads to hundreds of thousands of U.S. treatments annually.