Pfizer to seek FDA approval for Lyme disease vaccine despite trial miss

Pfizer said it will ask the FDA to review a Lyme disease vaccine candidate after a late-stage trial missed its statistical goal because too few participants contracted the disease; the company reported more than a 70% reduction in infections among vaccinated participants and said no safety concerns were observed.

Pfizer announced plans to seek U.S. regulatory approval for a Lyme disease vaccine candidate. The company said a late-stage trial failed to meet its statistical goal because not enough people in the study contracted Lyme disease. Pfizer reported the vaccine reduced infections by more than 70% among those who received it and stated no safety concerns were observed. The candidate vaccine is designed to trigger antibodies that block transfer of the Lyme-causing bacteria from ticks to people. Key details: - The trial did not reach its statistical endpoint due to a lower-than-expected number of Lyme cases in the study population. - Pfizer plans to submit the trial data to the U.S. Food and Drug Administration for review. - The company reported more than a 70% reduction in infections among vaccinated participants and said no safety issues were identified in the trial. Summary: Pfizer will move forward with a regulatory filing for the Lyme vaccine candidate despite the trial missing its predefined statistical goal, citing the observed reduction in infections and an absence of safety concerns. Regulators will review the submitted data and determine whether the evidence supports approval; timing and the outcome of that review are currently undetermined.