Europe begins formal review of the Pfizer–Valneva Lyme vaccine

What happened

On August 14, 2026, Pfizer and Valneva announced that the European Medicines Agency (EMA) had validated their marketing application for PF-07307405, a Lyme disease vaccine candidate once known as VLA15. “Validated” means the agency confirmed the application is complete and has started its formal scientific review. It is not an approval.

The application is built on the phase 3 VALOR trial. It enrolled 9,437 people aged 5 and older at high-risk sites in the United States, Canada and Europe. Half got the vaccine and half got a saline (salt-water) placebo. The companies report that the vaccine was more than 70% effective at preventing confirmed Lyme disease and was well tolerated, with no safety concerns identified at the time of analysis.

The vaccine targets a protein on the surface of Lyme bacteria called OspA. It is designed to cover the six OspA types most common in North America and Europe. You can read more about how it works on our Lyme disease vaccine guide.

What it means for you

• It is real progress. This is the furthest a human Lyme vaccine has gone since the earlier LYMErix vaccine left the U.S. market more than two decades ago. A regulator is now looking closely at the full data.
• Nothing changes this season. The companies note there is no approved human Lyme vaccine today. Tick-bite prevention, quick tick removal and watching for symptoms are still your best tools.
• Europe is first in line. The EMA filing covers the European Union. A European decision does not by itself make the vaccine available in the United States.

What it does not mean

• It is not approved anywhere yet. Validation only starts the review. Regulators can ask questions, request more data, approve or refuse.
• It is not a U.S. approval on the way. The U.S. Food and Drug Administration (FDA) runs its own separate review. The company announcements we reviewed did not give a U.S. filing date.
• It is not 100% protection. “More than 70%” means fewer cases, not zero. The wide confidence intervals mean the true effect could be somewhat lower or higher than the headline number.
• It would not prevent other tick diseases. Because it targets Lyme bacteria only, it is not designed to protect against babesiosis, anaplasmosis, Powassan virus or alpha-gal syndrome. See our co-infections guide.
• It is not a treatment. A vaccine like this is meant to prevent infection. It would not treat a current infection or lingering symptoms after Lyme. For those, see Lyme disease treatment and chronic Lyme disease.

What happens next

Under the EMA’s standard process, its medicines committee (the CHMP) reviews an application for up to 210 “active” days. The clock pauses whenever the company is answering the committee’s questions, so the calendar time is usually longer. The committee then gives an opinion, and the European Commission has up to 67 days to issue a legally binding decision. The companies have not announced a target decision date.

We will update our vaccine guide and research tracker when there is news from the EMA or the FDA. Until then, the steps on our How to beat Lyme hub, starting with preventing tick bites, are what protect you today.