UTI vaccines exist and are used clinically in parts of Europe, but no vaccine for urinary tract infections has received FDA approval in the United States. Three products are currently available in various countries: a sublingual spray called MV140 (sold as Uromune), an oral capsule known as Uro-Vaxom (OM-89), and an injectable vaccine called StroVac. Where you live largely determines which of these you can access, and the path to getting one ranges from a simple prescription to navigating special-access programs or traveling abroad.
Three Vaccines, Three Routes
The UTI vaccines on the market today take very different approaches, and understanding the differences helps explain why availability is so uneven around the world.
MV140, marketed under the brand name Uromune, is a sublingual spray containing whole inactivated bacteria from four species commonly responsible for urinary infections. You spray it under the tongue daily for three months. It was developed in Spain and works by stimulating a mucosal immune response, prompting the body to produce immune cells that specifically target urinary pathogens. Animal and human studies confirm that it triggers both local immune activity in the urinary tract and a broader systemic response.1PubMed Central. MV140 mucosal bacterial vaccine improves uropathogenic E. coli clearance in an experimental model of urinary tract infection Multiple study designs, from observational work to randomized placebo-controlled trials, have shown it safely reduces UTI recurrence in women.2PubMed Central. An Effective Sublingual Vaccine, MV140, Safely Reduces Risk of Recurrent Urinary Tract Infection in Women
Uro-Vaxom (OM-89) is an oral capsule containing an extract from 18 strains of E. coli. Rather than whole bacteria, it delivers bacterial fragments that stimulate the immune system to ramp up its defenses, including boosting levels of protective IgA antibodies in the urine and activating T cells.3PubMed Central. Efficacy and Safety of Uro-Vaxom in Urinary Tract Infection Prevention: A Systematic Literature Review Uro-Vaxom has been available since the 1990s in parts of Europe and Asia. It is the most widely studied UTI vaccine globally, though the evidence, while positive, shows a more modest effect than MV140.
StroVac is an intramuscular injection available in Germany and Austria. It contains 10 strains of inactivated bacteria from five species, including E. coli, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, and Enterococcus faecalis.4Nephrology Dialysis Transplantation. Successful Prophylaxis with StroVac Vaccine Against Urinary Tract Infection After Kidney Transplantation The standard regimen involves three injections given at two-week intervals, with a booster available about a year later.
Where Each Vaccine Is Available
MV140 (Uromune) is most easily accessible in Spain, where it was developed and has been prescribed for over a decade. It is also available in parts of Latin America, and doctors in the United Kingdom have used it in clinical settings. A prospective UK study found it safe and effective at preventing UTIs in women, and a larger randomized trial was launched there.5PubMed. First experience in the UK of treating women with recurrent urinary tract infections with the bacterial vaccine Uromune In North America, MV140 does not have regulatory approval. However, the first North American clinical-experience study was conducted in Canada, where 67 women with recurrent UTIs underwent the three-month vaccination course. About 41% remained completely UTI-free for the nine-month follow-up, and overall UTI rates dropped by roughly 75% compared to the year before vaccination.6PubMed Central. MV140 sublingual vaccine reduces recurrent urinary tract infection in women Results from the first North American clinical experience study Access in Canada was through a special-access or clinical-study framework, not standard pharmacy shelves.
Uro-Vaxom has the broadest geographic reach. It is licensed in over 30 countries, primarily across Europe, parts of Asia, and some Latin American markets. In many of those countries, a doctor can write a standard prescription. It is not approved in the United States, Canada, or the UK, although some patients access it through personal importation or travel.
StroVac is essentially a German product. It is approved and covered by statutory health insurance in Germany, and it is also available in Austria. Outside the German-speaking world, access is very limited. It is not approved in the UK, the US, or Canada.
The Situation in the United States
If you live in the US, you cannot currently walk into a clinic and receive any of these vaccines. None have completed the FDA approval process. This is not because the science is lacking, but because the regulatory pathway for bacterial vaccines targeting recurrent infections is complex, and no manufacturer has yet completed the required Phase III trials on American soil to FDA standards.
Some American patients have pursued workarounds. A small number have obtained Uro-Vaxom through international pharmacies or while traveling. Others have looked into clinical trials. As vaccine developers move toward larger international trials, enrollment opportunities may emerge, but as of now, there is no reliable domestic route to access any UTI vaccine in the US. Asking your urologist about ongoing trials is the most practical step, since trial enrollment is the one pathway that does not require leaving the country.
How Well Do They Work
The strongest controlled-trial evidence belongs to MV140. A randomized, placebo-controlled trial found that women receiving three or six months of MV140 had a median of zero UTI episodes during the study period, compared with a median of three in the placebo group. More than half of MV140-treated women stayed completely UTI-free, versus a quarter of those on placebo.7PubMed. Sublingual MV140 for Prevention of Recurrent Urinary Tract Infections Follow-up data from observational studies suggest that protection can persist for years, with some reports tracking patients who remained infection-free nearly a decade after vaccination.
Uro-Vaxom’s efficacy is more modest but still meaningful. A large, long-term, multicenter placebo-controlled trial in women with recurrent UTIs showed about a 34% reduction in infection rate compared to placebo, with roughly 40% of vaccinated women experiencing UTIs during follow-up versus 55% in the placebo group.8PubMed. A long-term, multicenter, double-blind study of an Escherichia coli extract (OM-89) in female patients with recurrent urinary tract infections That is a real benefit but noticeably smaller than what MV140 has shown in its trials.
StroVac’s evidence is more complicated. Uncontrolled and comparative studies have reported strong results, with one single-center study concluding it was effective and lasting as non-antibiotic prevention for recurrent UTIs.9PubMed. Efficacy of vaccination with StroVac for recurrent urinary tract infections in women: a comparative single-centre study However, a prospective randomized placebo-controlled trial told a more nuanced story. The StroVac group saw UTI rates drop from an average of 5.5 per year to 1.2, which sounds impressive until you learn the placebo group dropped from 5.4 to 1.3. The difference was not statistically significant. The researchers traced this to a flaw in their placebo, which turned out to have antibacterial properties of its own.10PubMed Central. Prospective multicentre randomized double-blind placebo-controlled parallel group study on the efficacy and tolerability of StroVac in patients with recurrent symptomatic uncomplicated bacterial urinary tract infections So the drug clearly reduced infections, but the trial could not prove it worked better than an inert injection because the control was not truly inert. That trial is a good illustration of how difficult it is to generate clean vaccine evidence, and it means StroVac’s efficacy rests more heavily on observational data than the other two products.
A 2024 systematic review and meta-analysis looking across bacterial UTI vaccines concluded that the products are safe and may reduce recurrence risk for about 6 to 12 months.11PubMed. Bacterial Vaccines for the Management of Recurrent Urinary Tract Infections: A Systematic Review and Meta-analysis That conservative estimate reflects the limitations of available trials, especially their modest size and follow-up periods. Longer observational data, particularly for MV140, paints a more optimistic picture of durability.
Why Vaccines Instead of Antibiotics
The appeal of UTI vaccines is hard to overstate for anyone stuck in the cycle of recurrent infections and repeated antibiotic courses. Standard antibiotic prophylaxis does work for prevention, but it comes with a well-known expiration date: the longer you take low-dose antibiotics, the greater the risk of breeding resistant bacteria. A literature review on Uromune explicitly positioned it as a safe and potentially cost-effective alternative to conventional antibiotic prophylaxis precisely because of rising antimicrobial resistance.12PubMed Central. Current Evidence on Safety, Efficacy and Efficiency of Sublingual Vaccine Uromune® in Prevention of Recurrent Urinary Tract Infections: A Literature Review
The economic argument also tilts toward vaccines. A Spanish study directly compared the costs of continuous antibiotic prophylaxis to immunoprophylaxis with MV140. At both three and six months of follow-up, both the standard polybacterial vaccine and a custom autovaccine version produced fewer UTIs and lower overall healthcare costs than ongoing antibiotics.13Actas Urológicas Españolas (English Edition). Effectiveness and health cost analysis between immunoprophylaxis with MV140 autovaccine, MV140 vaccine and continuous treatment with antibiotics to prevent recurrent urinary tract infections The savings come not just from the vaccine itself costing less than months of antibiotics and the clinic visits they entail, but also from the downstream costs of fewer breakthrough infections, fewer emergency visits, and fewer resistant infections that require stronger and more expensive drugs.
Who Is a Candidate
The typical profile for a UTI vaccine candidate is a woman with recurrent UTIs, usually defined as three or more documented infections per year. That threshold appeared consistently across the clinical trials: the Canadian MV140 study, for example, enrolled women with at least three documented UTIs annually, and participants had averaged nearly seven per year before vaccination.6PubMed Central. MV140 sublingual vaccine reduces recurrent urinary tract infection in women Results from the first North American clinical experience study Most research has focused on adult women because they bear the overwhelming burden of recurrent UTIs, but that does not mean men are categorically excluded. The vaccines target bacterial pathogens that affect both sexes, and some urologists in countries where the vaccines are available have prescribed them off-label for men with recurrent infections, particularly those with structural urinary tract issues.
You do not need to have tried and failed antibiotic prophylaxis first, though in practice many patients who seek out vaccines have already been through that cycle. The vaccines are generally positioned as an alternative or complement to other prevention strategies rather than a last resort.
Children and Special Populations
Evidence for UTI vaccines in children is thin. A systematic review of vaccines for pediatric urinary tract infections found very limited data, and it highlighted a particular gap for children with neurogenic bladder who depend on catheterization. In that group, catheter-associated colonization creates a different kind of infection dynamic, and vaccine efficacy for catheter-associated UTIs remains unproven.14Journal of Pediatric Surgery Open. Vaccines for urinary tract infections in children: A systematic review For now, pediatric use of UTI vaccines is essentially off the map from a formal evidence standpoint, even in countries where the adult vaccines are available.
People who have received kidney transplants represent another interesting special population. A study of StroVac in kidney transplant recipients found that vaccination significantly reduced the annual incidence of UTIs, with a manageable safety profile.4Nephrology Dialysis Transplantation. Successful Prophylaxis with StroVac Vaccine Against Urinary Tract Infection After Kidney Transplantation That finding is encouraging because transplant patients are immunosuppressed and highly susceptible to urinary infections, making antibiotic resistance an even more pressing concern for them. Still, the data come from a small study, and this use is far from standard practice.
How to Actually Pursue Access
If you are in a country where one of these vaccines is approved, the path is relatively straightforward. In Spain, you can ask your urologist or general practitioner about Uromune. In Germany, StroVac is available by prescription, and statutory insurance typically covers it. In countries where Uro-Vaxom is licensed, you may be able to get it from a standard pharmacy. The practical step in all cases is the same: tell your doctor you are interested in immunoprophylaxis for recurrent UTIs and ask which products are available locally.
If you are in the US, UK, or another country where no UTI vaccine is approved, the options are more creative and more limited. Searching clinical trial registries for active enrollment is the most straightforward legal pathway. Some patients in the UK have accessed MV140 through specialist urologists who obtain it via named-patient or compassionate-use frameworks. In Canada, the clinical experience study demonstrated that special-access pathways can work, even if they require more persistence than a normal prescription. Personal importation of Uro-Vaxom from an overseas pharmacy is something some patients pursue on their own, though the legal and quality-assurance aspects of doing so vary by country and carry inherent risks.
One thing worth being realistic about: even in countries where these vaccines exist, not every doctor knows about them. UTI vaccines have not yet entered mainstream treatment guidelines in most places, and many general practitioners have never heard of Uromune or Uro-Vaxom. A referral to a urologist who specializes in recurrent infections, or to a center associated with vaccine research, is likely to be more productive than raising the topic at a routine appointment.
What Is Coming Next
The current generation of UTI vaccines relies on whole killed bacteria or bacterial extracts, which prime the immune system against a broad set of bacterial components. Researchers are now working on more targeted approaches. One promising line of development focuses on FimH, a protein that sits at the tip of the tiny hair-like structures E. coli uses to latch onto the bladder wall. By designing a vaccine around a stabilized version of that protein, researchers hope to train the immune system to block bacterial attachment before an infection can take hold.15bioRxiv. Structure-Based Design of a Highly Immunogenic, Conformationally Stabilized FimH Antigen for a Urinary Tract Infection Vaccine This kind of precision approach could theoretically produce stronger and more durable immunity than the current whole-cell vaccines, though it is still in preclinical and early clinical stages.
Other research groups are exploring multi-epitope vaccine designs that try to cover not just E. coli but also Proteus mirabilis, Klebsiella pneumoniae, and other species responsible for UTIs.16Biotechnology Reports. Protective multi-epitope candidate vaccine for urinary tract infection This matters because while E. coli causes the majority of UTIs, a meaningful fraction are caused by other bacteria. A vaccine that protects only against E. coli would leave those infections unaddressed. The multi-pathogen approach mirrors what StroVac already attempts by including five bacterial species, but the next-generation versions aim to be more immunologically precise.
How quickly any of this reaches clinics depends on regulatory progress. Given that existing vaccines like MV140 are still working through regulatory pathways in the US and other large markets, the pipeline products are likely a decade or more from widespread availability. For people dealing with recurrent UTIs right now, the existing vaccines remain the most relevant options, with access defined largely by geography and willingness to navigate the available workarounds.