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Pfizer, Valneva Seek Approval for Lyme Vaccine After >70% Efficacy in Phase 3

Regulators will judge strong efficacy against limited case counts.

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

Overview

  • Pfizer and Valneva, which on Monday reported Phase 3 results, said their vaccine cut confirmed Lyme cases by 73.2% after the fourth dose and that they will seek FDA and EU review.
  • The trial’s primary endpoint was missed because the 95% confidence interval’s lower bound was 15.8% versus the 20% target, yet a second pre-specified analysis showed 74.8% efficacy and met the threshold.
  • The shot targets the Lyme bacterium’s OspA protein, prompting antibodies that a feeding tick ingests to block the microbe in the tick’s gut, and it is given as three doses in year one with a booster in year two.
  • Case numbers were low after the sponsors removed about half of the original 18,000 enrollees in 2023 over site-quality problems at Care Access, leaving roughly 9,400 participants and less statistical power, and no safety issues were reported.
  • There is no current human Lyme vaccine after LYMErix was withdrawn in 2002, and if regulators agree the data support effectiveness, a first return to market could come as soon as late 2027 based on Valneva’s prior guidance.