Pfizer announced it will pursue regulatory approval for its Lyme disease vaccine candidate even though the vaccine failed to meet the primary endpoint in a late-stage trial. The trial missed statistical significance because too few participants contracted Lyme disease, but Pfizer reported the vaccine showed over 70% efficacy in reducing infection rates compared to placebo. The company believes this efficacy is strong enough to justify moving forward, aiming to introduce the first human Lyme disease vaccine. Partner Valneva projects peak annual sales of over $1 billion, though this is modest compared to Pfizer's overall revenue. The vaccine involves a series of three shots in the first year plus a booster and showed no safety concerns during trials. This move could test U.S. vaccine regulatory standards amid heightened scrutiny.
