What UTI Vaccines Are Available in Europe?

Three bacterial immunotherapy products are currently marketed in European countries for preventing recurrent urinary tract infections: Uro-Vaxom (OM-89), an oral capsule available across much of Europe; Uromune (MV140), a sublingual spray authorized in Spain and accessible in several other countries; and StroVac, an injectable vaccine licensed in Germany and Austria. None of these are traditional vaccines in the way most people picture them, and none have achieved continent-wide regulatory harmonization, which means access depends heavily on where you live. The landscape also includes individualized autovaccines prepared by specialized pharmacies, and a handful of pipeline candidates working through clinical trials.

Uro-Vaxom (OM-89), the Most Widely Available Option

Uro-Vaxom has been on the market the longest and is the most broadly available UTI immunotherapy in Europe. It is an oral capsule containing lysates of 18 strains of uropathogenic E. coli, the bacterium responsible for the majority of uncomplicated UTIs. The standard regimen involves one capsule daily for 90 consecutive days as an initial course, followed by booster courses of 10 days per month for three months.

The product works by stimulating immune responses in the gut-associated lymphoid tissue, which in turn primes mucosal defenses in the urinary tract. A retrospective study found that patients averaged about 3.1 UTI episodes in the year before starting Uro-Vaxom, dropping to roughly 1.5 episodes in the year afterward.¹ That is roughly a halving of infections, which for someone who has been dealing with three or more UTIs a year, can be a meaningful improvement in daily life.

Uro-Vaxom is registered in over 30 countries, including many in the European Union, Switzerland, and parts of Asia and Latin America. Because it targets only E. coli, its effectiveness may be lower in people whose recurrent infections are driven by other organisms like Klebsiella, Proteus, or Enterococcus. It does not require a prescription in all markets, though medical supervision is recommended.

Uromune (MV140), the Sublingual Spray

Uromune, also marketed as MV140, takes a broader approach. It is a sublingual spray containing heat-inactivated whole bacteria from four species commonly implicated in UTIs: E. coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis. The patient sprays two puffs under the tongue daily for three months, where the bacteria interact with immune cells in the oral mucosa.

The randomized, placebo-controlled trial published in NEJM Evidence provided the strongest clinical data so far. Women receiving MV140 for either three or six months had a median of zero UTI episodes during follow-up, compared to a median of three episodes in the placebo group. About 56 to 58 percent of vaccinated women remained completely UTI-free, versus only a quarter of those on placebo.² Those numbers are striking for a condition that, by definition, keeps coming back.

A literature review found the vaccine has a favorable safety profile, with predominantly mild adverse effects and a low rate of people stopping treatment.³ Early UK experience with Uromune reported that about 78 percent of the 75 women who completed treatment had no subsequent UTIs during follow-up.⁴ Only one patient in that cohort had to stop due to an adverse reaction, a rash over the face and neck.

MV140 is manufactured by Inmunotek in Spain and holds marketing authorization there. In the UK and several other European countries, it has been accessible through named-patient or special-access schemes rather than full regulatory approval. This means your doctor can prescribe it, but the pathway to getting it may involve paperwork and out-of-pocket costs that vary by country. A broader European marketing authorization is still being pursued.

StroVac, the Injectable Option in Germany and Austria

StroVac is the product most people would recognize as a conventional vaccine: it is given as a series of intramuscular injections. The formulation contains inactivated bacteria from five species, including E. coli, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, and Enterococcus faecalis.⁵ Patients receive three injections at two-week intervals, with an optional booster at twelve months.

A comparative study at a single center found that roughly 87 percent of patients in the StroVac group had a successful outcome (defined as a significant reduction in UTI episodes) over the first twelve months, comparable to the 92 percent success rate seen with continuous low-dose antibiotics. Side effects led to treatment discontinuation in only about 2 percent of the StroVac group. In the second year, about 79 percent of StroVac patients were still doing well, most of whom had received the booster injection.⁶

StroVac is licensed in Germany and Austria but not broadly available across the EU. It evolved from an earlier product called Solco-Urovac, and the two names still sometimes appear interchangeably in older literature. For patients in German-speaking countries, StroVac is typically covered by statutory health insurance, making it one of the more accessible options if you live in the right place.

How These Products Compare to Each Other

The three products differ in route of administration, bacterial content, and geographic availability, but they share a basic concept: expose the immune system to killed or fragmented uropathogens so it mounts a faster, stronger defense when a live infection tries to establish itself. A systematic review pooling data across Uromune, Uro-Vaxom, and Solco-Urovac (StroVac’s predecessor) found a significant reduction in UTI risk with vaccination, with an odds ratio of 0.17 in short-term follow-up and 0.20 in longer-term follow-up, meaning vaccinated patients had roughly one-fifth the odds of recurrence compared to controls.⁷

Side effects across all the studied vaccines were mild and ranged from 0 to 13 percent across different studies, with very few patients needing to stop treatment.⁷ A 2024 meta-analysis concluded these bacterial vaccines are safe and may help lower the chances of recurrence for about six to twelve months.⁸ That time window is important: these are not one-and-done interventions. Most regimens envision either periodic booster doses or repeated treatment courses to maintain protection.

In practical terms, the sublingual spray is the least invasive, while the injectable route may suit people who prefer a set-it-and-forget-it schedule of three clinic visits. The oral capsule sits in between, requiring daily compliance over months. None of the three has been compared head-to-head against the others in a randomized trial, so “which is best” remains an open question.

Individualized Autovaccines

Beyond the commercial products, some European countries have a tradition of individualized autovaccines, particularly in Spain, Portugal, and parts of Central Europe. The idea is straightforward: bacteria are cultured from the patient’s own urine, identified, inactivated, and formulated into a personalized preparation. This ensures the vaccine targets the exact pathogen responsible for that patient’s infections, which is especially appealing when the culprit is an unusual organism not covered by off-the-shelf products.

A prospective cohort study of women receiving individualized autovaccine immunotherapy found that median UTI episodes dropped from four in the three months before treatment to zero at the three-month follow-up. At twelve months, the median was one episode, still significantly lower than baseline. About 40 percent of women remained completely UTI-free at each follow-up visit.⁹ Patient satisfaction was high, with most women scoring 4 or higher on a 5-point scale and nearly all saying they would choose to undergo autovaccination again.⁹

The drawback is availability and consistency. Autovaccines are typically prepared by compounding pharmacies under national magistral-formula regulations rather than through centralized EU marketing authorization. Quality control varies, the process takes time, and costs are often out of pocket. In Spain, some hospitals have used the MV140 platform alongside individualized autovaccine formulations, and one cost-effectiveness analysis compared the two approaches, finding that health costs over six months were lowest in the continuous antibiotic group but that the immunotherapy groups showed strong clinical benefits with costs that were in the same general range.¹⁰

Why These Are Not Called “Vaccines” Everywhere

If you search for UTI vaccines, you will notice that regulatory agencies, product labels, and even researchers do not always use the word “vaccine” for these products. Uro-Vaxom is often classified as an immunostimulant or bacterial lysate. StroVac is labeled a bacterial vaccine in Germany. Uromune sits somewhere in between, described as a sublingual bacterial preparation or immunotherapy depending on the source.

This inconsistency is not just branding. From a regulatory standpoint, the classification matters because it determines which pathway a product must follow to reach the market, what kind of clinical evidence is required, and whether it is reimbursed by national health systems. Products classified as “medicinal immunostimulants” may face different regulatory thresholds than those classified as vaccines, which partially explains why some of these products have been available for years in certain countries while remaining unknown in others. The fragmented regulatory picture is one of the biggest barriers to access: a product can be standard care in Madrid or Munich while being unavailable a few hundred kilometers away in Paris or Amsterdam.

The Antibiotic Resistance Angle

The growing interest in UTI immunotherapy in Europe is not happening in a vacuum. Antibiotic resistance among common uropathogens has been climbing steadily, and the standard prophylactic approach of giving low-dose antibiotics for months at a time contributes to the problem. A systematic review noted that shifting toward non-antibiotic prevention strategies, including bacterial vaccines, could help avoid antimicrobial resistance at least to some extent.¹¹

For individual patients, the appeal is simpler. Long-term antibiotics carry their own downsides: yeast infections, gut disruption, allergic reactions, and the uneasy knowledge that you are breeding resistant bugs in your own body. Immunotherapy offers an alternative that works with your immune system rather than against the microbes directly. Whether the broader public-health benefit materializes depends on how widely these products are adopted, which circles back to the regulatory and access challenges described above.

What Is Coming Down the Pipeline

Several next-generation candidates are in clinical development. The most advanced is the ExPEC conjugate vaccine program, initially developed as ExPEC4V and now expanded to ExPEC10V. Unlike the current products that use whole killed bacteria, these are bioconjugate vaccines targeting the O-antigen sugars on the surface of the most common disease-causing E. coli strains. The original ExPEC4V was designed based on epidemiological surveys in Switzerland, Germany, and the United States, identifying the four most prevalent serotypes causing UTIs. Early-phase testing in healthy women with a history of recurrent UTI showed strong safety and immunogenicity profiles.¹²

The expanded version, ExPEC10V, covers ten E. coli serotypes and has been tested in a phase 1/2a trial. It showed an acceptable safety profile and a robust immune response in participants with a history of UTI.¹³ If it clears larger efficacy trials, it would be the first UTI vaccine to go through the traditional vaccine regulatory pathway in Europe, potentially achieving the kind of broad marketing authorization the current products lack.

On the more experimental side, researchers have been exploring nanofiber-based sublingual delivery systems designed to penetrate the mucus layer under the tongue and generate antibody responses both in the bloodstream and in the urogenital tract.¹⁴ This is still preclinical work, but it points toward a future where sublingual vaccines could be engineered for more targeted immune responses than current whole-bacteria preparations allow.

Who Is a Good Candidate and How to Access These Products

These immunotherapies are designed for people with recurrent UTIs, typically defined as three or more confirmed infections in twelve months or two or more in six months. The evidence base is strongest for women, who make up the vast majority of recurrent UTI sufferers. The UK study with Uromune noted that most recurrences in their cohort occurred in postmenopausal women, reflecting the general epidemiology of recurrent UTIs.⁴ Data in men and in people with complicated urinary tract anatomy (such as neurogenic bladder or indwelling catheters) is much thinner, and these products should not be assumed to work the same way in those populations.

Access depends entirely on your country. In Spain, Uromune is available by prescription, and individualized autovaccines can be ordered through certain hospitals. In Germany and Austria, StroVac is a standard option your urologist or gynecologist can prescribe. Uro-Vaxom is the most widely registered and is available in pharmacies across much of Europe, sometimes without a prescription. In the UK, Uromune has been used through specialist clinics on an unlicensed basis, meaning your doctor prescribes it but takes personal clinical responsibility. In France, Scandinavia, and the Benelux countries, access to any of these products is more limited and may require importation.

If you are dealing with recurrent UTIs and want to explore immunotherapy, the practical first step is to ask your urologist or gynecologist whether any of these products are available in your country, and whether they have experience prescribing them. Clinical awareness varies widely: some specialists are enthusiastic advocates, while others remain skeptical because the evidence, while growing, has not yet reached the scale of large Phase 3 trials that regulators in northern European countries tend to demand. The real-world satisfaction data is encouraging, with one North American study finding that about 80 percent of women reported moderate or marked improvement at twelve months, and most were satisfied or delighted with their treatment.¹⁵ But getting from “this looks promising” to “widely prescribed across Europe” is still a work in progress.

What These Products Cannot Do

It is worth being clear about the limitations. No currently available UTI immunotherapy is a cure. They reduce the frequency and severity of recurrent infections, but protection appears to wane over time without boosters, and a proportion of patients will still experience breakthrough UTIs. The meta-analytic evidence suggests the window of meaningful protection is roughly six to twelve months.⁸ This is not unusual for mucosal immunity, which tends to be shorter-lived than the systemic immunity generated by, say, measles vaccination.

These products also do not treat an active UTI. They are purely preventive. If you currently have a burning infection, you still need antibiotics (or another antimicrobial) to clear it. The immunotherapy is started after the acute episode resolves, ideally during an infection-free window, to reduce future recurrences.

Finally, the commercial products each cover a limited set of bacterial species. Uro-Vaxom covers only E. coli. Uromune and StroVac cover four to five species, which together account for the large majority of uncomplicated UTIs, but not all of them. If your recurrent infections are caused by an uncommon organism, an individualized autovaccine may be a better fit, where available. Your doctor can determine the responsible pathogen through urine cultures, which ideally should be done before any immunotherapy is started.