Urinary Tract Infections (UTIs) are common bacterial infections that can cause discomfort and lead to serious health issues if left untreated. While antibiotics are the standard treatment, recurrent UTIs pose a challenge, often leading to repeated antibiotic use and concerns about antibiotic resistance. Vaccines offer a promising approach to prevent these recurring infections by training the body’s immune system to fight off bacteria before an infection takes hold, aiming to reduce UTI frequency and lessen antibiotic reliance.
Understanding UTI Vaccines
A UTI vaccine prepares the immune system to recognize and combat the bacteria that commonly cause urinary tract infections. The primary goal is to prevent recurrent episodes, defined as two or more infections within six months or three or more within a year. These vaccines generally target uropathogenic Escherichia coli (E. coli), which is responsible for over 85% of cystitis cases and more than 60% of recurrent infections.
The vaccines introduce inactivated or fragmented bacterial components to the immune system without causing disease. This exposure allows the body to develop a protective immune response, including antibody production and the activation of specific immune cells. When the body encounters the actual bacteria, its primed immune system can mount a faster, more effective defense, reducing the likelihood of infection or symptom severity.
Approved and Emerging UTI Vaccines in Europe
Europe has seen the availability of specific UTI vaccines designed to prevent recurrent infections. Two prominent examples are Uro-Vaxom and MV140, also known as Uromune.
Uro-Vaxom is an oral immunotherapeutic widely used in Europe. It consists of lyophilized bacterial lysate from 18 heat-killed strains of Escherichia coli, the most frequent cause of UTIs. This oral capsule stimulates immunocompetent cells in the intestinal lining, such as Peyer’s plaques, promoting antibody production and activating T-lymphocytes for an enhanced immune response against E. coli. Uro-Vaxom has been available for many years and is recommended by the European Association of Urology (EAU) in its guidelines.
MV140, marketed as Uromune, is another vaccine available in some European countries, administered as an intranasal or sublingual spray. This polyvalent bacterial vaccine contains inactivated whole cells from four common species associated with UTIs: Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, and Proteus vulgaris. The sublingual route, with two daily sprays under the tongue for three months, allows the vaccine to bypass digestive degradation. MV140 induces systemic and genitourinary tract immune responses, including antibody production and activation of dendritic cells, contributing to localized bladder protection. MV140 was first available in Spain in 2010 and is now accessible through special access programs in approximately 20 countries, including several in Europe.
Efficacy and Safety Considerations
Studies on UTI vaccines like Uro-Vaxom and MV140 show promising results in reducing recurrent urinary tract infections.
Uro-Vaxom has demonstrated a significant reduction in UTI recurrence rates, with reported reductions ranging from 34% to over 80% compared to placebo. One retrospective study noted a decrease in the average number of UTIs from 3.14 in the year before treatment to 1.53 in the year following administration.
MV140 has also shown considerable efficacy, with clinical studies indicating a reduction in total UTIs by about 70%. A randomized, placebo-controlled trial found that MV140 increased UTI-free rates from 25% in the placebo group to 55.7% and 58.0% in groups receiving MV140 for three and six months. The median time to the first UTI after treatment increased from 48 days to 275 days. Initial long-term follow-up data suggest 54% of participants remained UTI-free for up to nine years after vaccination.
Both Uro-Vaxom and MV140 are well-tolerated, with side effects typically mild and infrequent. For Uro-Vaxom, reported adverse effects include urethral symptoms, skin rash, gastrointestinal discomfort, headache, and increased blood pressure, with no reports of anaphylaxis. MV140 has been associated with minor side effects such as skin rash, mucosal burning, upper gastrointestinal discomfort, and fatigue, all mild and resolving within three months.
Access and Regulatory Landscape in Europe
Access to UTI vaccines in Europe varies by country, influenced by national health systems and regulatory approvals. Both Uro-Vaxom and MV140 generally require a prescription. Uro-Vaxom has been approved and widely used in many European countries for years.
MV140 (Uromune) is available in several European countries, often through “named patient” or special access programs, which allow for the use of unapproved medicines in specific cases. It became available in Spain in 2010 and is currently accessible in approximately 20 countries, including parts of England. While some countries have direct commercial availability, others may require specific procedures for obtaining the vaccine.
Regulatory pathways for vaccine approval in Europe are overseen by the European Medicines Agency (EMA) for centralized approval, or by national authorities for country-specific approvals. The EMA evaluates a vaccine’s quality, safety, and efficacy based on testing and clinical trial data. If benefits outweigh risks, the EMA can grant a marketing authorization, valid across all European Union and European Economic Area countries. However, individual European countries also decide whether to include vaccines in their national health programs and provide coverage. This dual system means that while a vaccine might be EMA-approved, its practical availability and reimbursement can still differ significantly between member states.