What is the Uromune vaccine?
Uromune, also known by its clinical trial name MV140, is a sublingual (under the tongue) vaccine designed to prevent recurrent urinary tract infections (rUTIs). Unlike traditional injectable vaccines, it is a pineapple-flavored spray containing an inactivated combination of four bacteria most commonly responsible for UTIs: Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, and Proteus vulgaris. The vaccine works by stimulating the body's immune system to recognize and fight these uropathogens more effectively, thereby reducing the risk of future infections. A typical course of treatment involves administering two sprays once daily for three months.
Uromune's regulatory status and availability
Crucially, Uromune is not approved by the U.S. Food and Drug Administration (FDA) and is therefore not commercially available in the United States. Shipments to the U.S. were also paused as of July 2023. Similarly, in Canada, the manufacturer has voluntarily withdrawn its application, meaning it is not available for purchase there.
However, Uromune is available in many other countries through special access or compassionate use programs. This pathway allows for the use of an investigational drug for patients with serious conditions when no other treatment options are available. The vaccine was initially developed and marketed in Spain but is now offered in a range of countries, predominantly in Europe, as well as in Mexico, the Dominican Republic, Australia, and New Zealand.
How to get Uromune: A step-by-step guide
- Get a Specialist Referral: The first and most critical step is to consult a healthcare specialist, such as a urologist, urogynaecologist, or microbiologist. Your general practitioner can provide a referral. This specialist will evaluate your history of recurrent UTIs to confirm Uromune is the right treatment option for you.
- Receive a Specialist Prescription: If the specialist determines that Uromune is suitable, they can issue a prescription. In countries where the vaccine is available via special access, the prescription must come from a designated hospital specialist, not a general practitioner. The typical prescription is for a 3-month course of treatment.
- Find a Special Access Clinic: For patients in countries where the vaccine is not commercially available, you must find a clinic or medical provider that participates in the special access program. Organizations like Vax-Before-Travel maintain lists of international clinics that offer the vaccine.
- Consider International Travel: For patients in regions like the U.S. or Canada, obtaining the vaccine often requires international travel to a country where it is accessible. You would need to arrange for a consultation with a local specialist in that country to receive the prescription and complete the treatment.
- Acquire the Vaccine: The prescribed Uromune vaccine is typically dispensed by the hospital pharmacy or a specialty clinic. The product is a sublingual spray administered daily by the patient at home. The manufacturer, Inmunotek S.L. (based in Spain), has licensed distributors in various regions.
Comparison: Uromune vs. Standard Antibiotic Prophylaxis
| Feature | Uromune Vaccine (MV140) | Standard Antibiotic Prophylaxis |
|---|---|---|
| Treatment Method | Oral spray administered daily under the tongue for 3 months. | Oral tablets taken daily for a longer period, often 6 months or more. |
| Mechanism of Action | Trains the immune system with inactivated bacteria to fight off future infections. | Uses antibiotics to directly kill active bacteria, but doesn't prevent recurrence. |
| Long-Term Efficacy | Some studies show long-term prevention for over half of patients, with benefits lasting several years. | Effectiveness ceases when the course of antibiotics is finished; recurrence is common. |
| Side Effects | Generally mild and infrequent, including mouth irritation or GI upset. | Can cause more significant gastrointestinal issues, allergic reactions, and contributes to antibiotic resistance. |
| Impact on Resistance | Does not contribute to antimicrobial resistance. | Contributes to the growing global problem of antibiotic resistance with long-term use. |
| Availability | Requires specialist prescription and special access program enrollment; not available in all countries. | Widely available with a prescription from a general practitioner. |
Alternative options for recurrent UTIs
If the Uromune vaccine is not available in your region, or if you prefer an alternative approach, your doctor may recommend other strategies for managing rUTIs. These can include:
- Other non-antibiotic strategies: Your doctor might suggest alternatives to Uromune, such as D-mannose supplements, methenamine hippurate, or vaginal estrogen therapy for postmenopausal women.
- Dietary and lifestyle adjustments: Increasing fluid intake, urinating after intercourse, and ensuring complete bladder emptying are common recommendations.
- Specialist care: Consulting a specialist may also uncover underlying issues contributing to rUTIs, such as kidney stones or other urological conditions, that need to be addressed separately.
For those interested in the latest clinical research on Uromune (MV140), it is recommended to review information on the official clinical trials website. For example, the ongoing expanded access program NCT04173013 offers further details for prospective patients in eligible countries.
Conclusion
Getting the Uromune vaccine for recurrent urinary tract infections is a process that requires a specialist's prescription and may involve traveling to a country where it is available through a special access program. It is not commercially sold in major markets like the U.S. and Canada due to regulatory limitations. While clinical data show promising efficacy in reducing rUTIs and antibiotic use, its accessibility is currently limited. For those unable to access Uromune, other treatment and prevention strategies are available and should be discussed with a qualified healthcare professional.
Disclaimer: This information is for informational purposes only and does not constitute medical advice. Consult a healthcare professional for diagnosis and treatment of any medical condition.
