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2h ago

Pfizer, Valneva Lyme Vaccine Tops 70% in Phase 3 but Misses Primary Endpoint

Regulators now face an underpowered dataset against a high disease burden.

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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)
Photo: James Gathany; William L. Nicholson/CDC
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Overview

  • Pfizer and Valneva, which reported results Monday, said their vaccine cut confirmed Lyme cases by 73.2% in the primary read with a 15.8% lower bound below the required 20%.
  • A second pre-planned analysis that started one day after the fourth dose showed 74.8% efficacy and met the study’s confidence-interval threshold.
  • The trial captured fewer Lyme cases than expected and was trimmed to about 9,400 participants in 2023 after roughly half were dropped over site-quality problems at Care Access.
  • Pfizer plans to file with the FDA and European regulators, the topline data have not been peer reviewed, and the companies reported no safety concerns at the time of analysis.
  • The protein subunit shot targets OspA to load a feeding tick with antibodies and block Borrelia transmission, and the push comes as the CDC estimates about 476,000 U.S. treatments a year and around 132,000 cases reported in Europe.