UTI Vaccines in the United States

Vaccines present a different approach to treating urinary tract infections than antibiotics. While antibiotics work by trying to eliminate unwanted pathogens, vaccines instead aim to defend the body against infection by readying the body’s immune response. Another term for the category of medicine vaccines fall under is “immunostimulants,” as they quite literally stimulate the immune system to better fight off infections. 

For patients with recurrent or chronic UTI, the option for a vaccine to defend against the infection is appealing. This is particularly apt, as many people with long-term UTIs will develop antibiotic resistance, leading them to look elsewhere for treatment options. 

However, at the time of writing this article, there is still no approved vaccine for urinary tract infections in the United States. When you consider that the financial impact of UTIs in the United States alone is around 2 billion dollars annually, the lack of accessible treatment options for those with chronic UTI becomes a glaring issue.

Here, we will cover how UTI vaccines work, go over some of the vaccines for urinary tract infections available in other parts of the world, and finally, discuss the outlook of a UTI vaccine becoming approved in the USA.

How UTI Vaccines Work

The simple explanation of how vaccines work is that they purposefully trigger an immune response. This is achieved by taking what is called an antigen, or a weakened or inactive part of a pathogen, and inserting it into the body. The immune system is then able to learn how to defend against the pathogen without the body ever getting sick. This method is highly effective, and has been used safely since 1796!

Urinary tract infection vaccinations work in the same way. Although UTI vaccines overall have used multiple of the six main vaccination technologies, all of the UTI vaccines follow the same principle: that by introducing a weakened or inactive pathogen, the body can learn to fight against it. These vaccines can be delivered in a myriad of ways, from orally, under the tongue, as sprays, as suppositories, as intramuscular injections, or as an insertion directly into the bladder. 

Vaccines for UTI have been proven to be quite safe overall, with few adverse reactions reported. Metadata shows that of the 600-plus people who received Uro-vaxom, only 9 people had to stop taking it partway through. While this is only one vaccine, it indicates that science shows that UTI vaccines, like vaccines as a whole, trend toward being effective and safe.

Types of Vaccines

There are a myriad of UTI vaccines available elsewhere in the world. Below are a few of them.

• MV140, or Uromune: Taken sublingually, Uromune is a heat-inactivated vaccine. This means that the bacterial cells are rendered harmless by heat application and thus are able to be introduced to the immune system safely. Uromune is designed to target the pathogens of E. coli, E. faecalis, K. pneumoniae, and P. mirabilis. Its sublingual application is a plus, as studies have shown that sublingual vaccines can ignore gastrointestinal interference and that these vaccines can even trigger immune responses in tissues. It was developed in Spain.

• Uro-vaxom: Taken as an oral tablet. Like Uromune, Uro-vaxom is an inactivated vaccine. The bacteria are rendered inactive by lyophilization, or by freeze-drying. Uro-vaxom was initially developed in the 1980s in Switzerland, making it one of the oldest UTI vaccines. But while it has a long track record and is approved in over 30 countries, the United States has not given it FDA approval.

• Strovac: Taken as a vaginal suppository. Strovac targets 10 strains of bacteria rather than just E. coli, thus protecting against a larger group of pathogens than other UTI vaccines. It is an inactivated vaccine. Three injections of Strovac are initially given over a few weeks, and then a once-a-month booster is given for three months following. Strovac, or Solco-Urovac, was developed in Germany.

• ExPEC4V and ExPEC10V: Administered as an intramuscular injection, ExPEC4V is something called a conjugate vaccine. A conjugate vaccine works by combining a weak antigen with the protein of a stronger carbohydrate molecule as a carrier to facilitate a more effective immune response. ExPEC4V targets four main groups of pathogens, whereas its alternative vaccine, ExPEC10V, targets 10 pathogen groups. It is being developed by Johnson & Johnson in the United States. It’s important to note that the ExPEC vaccines are developed to target E. coli as a whole rather than UTI itself, and may be less pertinent to treating recurrent and chronic UTI.

• SEQ-400: SEQ-400 is a newer UTI vaccine currently under development. This vaccine works by fostering an immune response against FimH, which is a protein found in bacteria such as E. coli. Data from the first phase of clinical trials imply that immunization against FimH specifically may help fight off recurrent UTIs. As SEQ-400 is being developed specifically for use in the United States, there is hope that it may get approved.

Although none of these vaccines are available yet in the United States, many are currently in the process of clinical trials, and hopefully will become FDA-approved and accessible with time.

Why is There Still No Approved UTI Vaccine in the USA?

The variety of ways in which UTI vaccines work reveals part of the issue around why they still aren’t approved in the United States. The vaccines that are under development are highly differential, with none of them working entirely the same as another. This results in a lack of a cohesive push to get UTI vaccines FDA-approved.

Another issue is that in the health sphere, UTIs are not considered to be a research priority. As this condition is still incorrectly thought to have a low death rate, there is a lack of funds going into developing new research and getting that research approved. However, this is far from the truth. It has been estimated that 236,790 deaths occurred worldwide due to UTIs in 2019 alone, and the number has likely grown since. Despite this being a bureaucratic issue, it has had a huge impact on the lack of FDA approval around UTI vaccines.

As of June 2025, no UTI vaccines are available within the United States. This is a failure of our healthcare system, primarily for women and those with female anatomy, although men can be affected more frequently as they age. While some patients can afford to travel to get vaccines, most cannot, resulting in many people going without care or treatment. Especially in our current age of rapidly increasing antibiotic resistance, it is more pressing than ever that those living with urinary tract infections can have alternative treatment options.

However, the current presidential administration has axed the National Institutes of Health’s (NIH) grant funding for biomedical research. At the time of writing this, around $3.8 billion is no longer going into funding medical research grants. Unfortunately, this affects UTI research as well. It is likely that unless the NIH begins funding research grants again, UTI vaccines may not be approved in the United States for quite some time.

At Let’s Talk UTI, we are well aware of the consequences of axing the NIH’s grant funding. That’s why we are starting a coordinated effort to shine a light on UTI issues, even when our government refuses to. Keeping our community informed, aware, and knowledgeable of their options is our number one priority. As with any other medical condition, those living with urinary tract infections deserve treatment options, respite, and healing.