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Topic guideIs there a vaccine for Lyme disease? The 2026 update
Where the Pfizer and Valneva Lyme disease vaccine stands, what happened to the first human vaccine, and how to protect yourself until a new one arrives.
Quick answer
As of October 10, 2026, there is no Lyme disease vaccine for humans available in the United States. The leading candidate, from Pfizer and Valneva (formerly called VLA15), showed more than 70% efficacy in a large phase 3 trial. It is now under review in Europe. We found no public announcement of a U.S. FDA filing or approval yet.
Last checked October 10, 2026. Vaccine news moves fast. We re-check company and regulator announcements and will update this page when the status changes.
CDC’s advice has not changed while a vaccine is in development: the best protection is avoiding tick bites. That means using EPA-registered repellent, checking your body for ticks after being outdoors, and removing any attached tick quickly. CDC notes that tick exposure can happen year-round, with the most activity from April to September.
Where the Pfizer Lyme disease vaccine stands
The vaccine has had several names. Valneva first called it VLA15. Pfizer now uses the code PF-07307405, and Valneva also calls it LB6V. All three names refer to the same shot. Pfizer and Valneva have worked on it together since April 2020, and Pfizer would make and sell it if it is approved.
| Date | Milestone |
|---|---|
| July 2017 | FDA grants the candidate Fast Track designation, a status meant to speed review of promising products. |
| April 2020 | Pfizer and Valneva sign their partnership. |
| 2022 | The phase 3 VALOR trial begins. It eventually enrolled 9,437 people aged 5 and older in high-risk areas of the U.S., Canada and Europe. |
| March 23, 2026 | Pfizer and Valneva announce phase 3 results: Lyme cases were about 73% lower in the vaccine group than in the placebo group. |
| August 14, 2026 | The European Medicines Agency (EMA) validates the marketing application, which starts its formal review. |
| October 10, 2026 | No public announcement found of an FDA submission or approval. Valneva says regulatory decisions are expected within about the next 12 months. |
A note on the results: the trial had a strict statistical bar that the first planned analysis did not clear. The companies say this was because fewer people caught Lyme disease during the study than expected, which made the numbers less precise. A second planned analysis (74.8% efficacy) did meet the bar. The companies reported the vaccine was well tolerated, with no safety concerns identified at the time of analysis. Regulators will look at the full data before deciding.
How the new vaccine is designed
The candidate targets a protein on the surface of Lyme bacteria called OspA (outer surface protein A). It is “6-valent,” meaning it is built to cover six different types of OspA found in Lyme bacteria in North America and Europe. In the trial, people received a series of shots over more than a year, followed by tracking through tick season. If the vaccine is approved, regulators and public health advisers will decide who should get it and on what schedule.
Like any vaccine, it would not replace other precautions. Ticks also spread other infections, and no vaccine protects against all of them. Our guide to Lyme disease prevention covers everyday steps.
Was there ever a Lyme vaccine? The LYMErix story
Yes. A vaccine called LYMErix, made by SmithKline Beecham (later GlaxoSmithKline), was approved by the FDA in 1998. According to the American Lyme Disease Foundation, vaccinated people had a 76% reduction in Lyme disease after completing the full three-dose series.
It did not last. On February 26, 2002, GlaxoSmithKline withdrew LYMErix, citing poor sales. Demand had dropped amid negative news coverage about possible side effects and ongoing lawsuits. The American Lyme Disease Foundation describes those risk concerns as unfounded and says the withdrawal had nothing to do with the vaccine itself. Some patients still feel strongly the other way. Either way, Americans have had no human Lyme vaccine for more than two decades.
Other Lyme vaccines in development
The Pfizer and Valneva shot is by far the furthest along. Other approaches are at much earlier stages:
- Moderna mRNA candidates. Moderna has registered an early-stage safety and immune-response study of two mRNA candidates (mRNA-1975 and mRNA-1982) in adults aged 18 to 70. Early-stage studies like this come years before any possible approval.
We only list candidates we can verify through a trial registry or official announcement. Headlines about other “Lyme vaccines” often describe lab or animal research that has not been tested in people.
There is a Lyme vaccine for dogs
People are often surprised to learn that Lyme vaccines for dogs have been sold for years. These are veterinary products only and are not for people. Whether a dog should get one depends on where you live and your dog’s lifestyle, so it is a conversation for your vet. See our page on the Lyme disease vaccine for dogs.
What to do while you wait
- Use repellent and wear long sleeves and pants in grassy or wooded areas.
- Check yourself, your kids and your pets for ticks after time outdoors. Young ticks are about the size of a poppy seed.
- Remove attached ticks right away with fine-tipped tweezers. See what to do after a tick bite.
- Know the early signs, such as an expanding rash, fever or aches 3 to 30 days after a bite. See Lyme disease symptoms.
Be cautious of anyone offering a “Lyme vaccine” for people right now, or selling products described as vaccines or immune boosters for Lyme. No human Lyme vaccine is approved in the U.S. as of October 10, 2026. If you are at high risk and want to join a vaccine study, ask your doctor or search ClinicalTrials.gov.
We are collecting real experiences about waiting for a Lyme vaccine or taking part in vaccine trials from people who have lived it, shared with their permission. As stories come in, they will appear here, clearly marked as personal experience rather than medical advice.
Keep reading: Europe begins formal review of the Pfizer–Valneva Lyme vaccine and Lyme disease research: what’s new.
Frequently asked questions
Is there a vaccine for Lyme disease for humans?
Not right now in the U.S. As of October 10, 2026, no human Lyme vaccine is approved. The Pfizer and Valneva candidate has finished its phase 3 trial and is under review by the European Medicines Agency.
Is the Pfizer Lyme disease vaccine approved?
No, not as of October 10, 2026. The EMA validated Pfizer’s marketing application on August 14, 2026, which starts its review. We found no public announcement of an FDA filing or approval yet.
When will the new Lyme disease vaccine be available?
No one can say for sure. Valneva says regulatory decisions are expected within about the next 12 months. Even after approval, it takes time for health officials to make recommendations and for supplies to reach clinics.
Why was the first Lyme vaccine taken off the market?
LYMErix was approved in 1998 and withdrawn by its maker in 2002, which cited poor sales. Sales had fallen amid negative publicity about possible side effects and lawsuits.
Can people get the dog Lyme vaccine?
No. Dog vaccines are veterinary products tested only in animals. They are not approved or safe to use in people.
Sources
- Pfizer: Lyme disease vaccine candidate demonstrates strong efficacy in phase 3 VALOR trial (March 23, 2026)
- Pfizer: Marketing authorization application validated by the European Medicines Agency (August 14, 2026)
- Valneva: Lyme disease (LB6V/VLA15) program page
- American Lyme Disease Foundation: Lyme vaccines and therapeutics
- ClinicalTrials.gov: mRNA-1975 and mRNA-1982 against Lyme disease (NCT05975099)
- CDC: Preventing tick bites