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Pfizer to seek FDA approval for Lyme disease vaccine candidate despite trial miss
CNBC· 2026-03-23 13:36
Core Insights - Pfizer is seeking regulatory approval for a Lyme disease vaccine candidate despite it failing a late-stage trial [1][2] - The vaccine demonstrated a more than 70% reduction in infection rates compared to placebo, which Pfizer believes is sufficient for regulatory submission [2][3] Company Overview - The Lyme disease vaccine is not expected to be a major revenue driver, with peak annual sales estimated at $1 billion by partner Valneva, while Pfizer's overall revenue forecast for the year is around $60 billion [4] - The Covid-19 vaccine is projected to contribute over $5 billion to Pfizer's revenue this year [4] Clinical Trial Details - The vaccine trial missed its statistical goal due to insufficient cases of Lyme disease among participants, leading to a reduction in the study size from approximately 18,000 to 9,400 participants [2][8] - No safety concerns were reported during the trial [9] Market Context - Lyme disease affects about half a million Americans annually, yet there is currently no human vaccine available, following the withdrawal of LYMErix in 1998 due to safety concerns [6][7] - The vaccine targets the outer surface protein A of the Lyme disease-causing bacteria, aiming to prevent transmission from ticks to humans [9]