Madison Area Lyme Support Group

At the TD Cowen Health Care Conference in Boston this week, executives from the French biotech firm Valneva outlined their strategic roadmap to institutional investors. The presentation by CEO Thomas Lingelbach and CFO Peter Buhler placed overwhelming emphasis on a single, pivotal asset: its candidate for a Lyme disease vaccine. The company’s future trajectory appears heavily dependent on this program, with final Phase 3 data anticipated in the first half of 2026.

A High-Stakes Clinical Catalyst

Valneva is advancing the pivotal Phase 3 trial for what could become the world’s only Lyme disease vaccine in late-stage development, in collaboration with pharmaceutical giant Pfizer. The U.S. Food and Drug Administration (FDA) has already granted the project Fast Track designation. Should the upcoming topline results confirm both efficacy and safety, Pfizer intends to submit applications for regulatory approval to the FDA and the European Medicines Agency (EMA) before the end of 2026.

This binary event is reflected in the equity’s performance. Valneva shares currently trade at €4.73, having nearly doubled in value over the past twelve months. This valuation incorporates significant market expectations for a positive trial outcome. Investor anxiety ahead of the data release is further evidenced by the stock’s substantial volatility, which stands above 53% on a 30-day basis. (See link for article)

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**Comment**

Despite experts and advocates shouting at the top of their lungs that Valneva’s VLA15 Lyme vaccine is based on similar OspA-based tech as LYMErix which is responsible for 1000+ adverse reactions and ongoing severe complications, the FDA predictably gave it fast-track designation.  This should not surprise anyone.  The FDA could give two hoots about whether or not a ‘vaccine’ is truly ‘safe and effective.’

Just look at the clot shot for affirmation of this simple fact.  It has caused more adverse reactions and death than ANY other vaccine in the history of VAERS yet it’s still on the market amidst cries to pull it off the market, and despite being absolutely worthless with negative efficacy the more shots you get.