Sublingual vaccine for urinary tract infections is awaiting approval by Health Canada

Canadians who experience chronic urinary tract infections may soon have another option than antibiotics — a vaccine is awaiting approval by Health Canada.

Urinary tract infections, known as UTIs, are one of the most common infections across the globe.

They cause extreme discomfort in patients, and require antibiotics in order to clear the infection. Dr. Marla Shapiro, CTV’s medical contributor, explained the two main symptoms to CTV News Channel on Friday.

“The hallmark really is that urgency, that you’ve gotta get to the washroom in time,” she said. “There can be burning either initiating the urination or at the end of it.”

There might also be blood in the urine, or it could be cloudy, and often the odour of the urine will have changed. Some sufferers of UTIs have even reported pelvic pain.

“But it’s usually that razorblade burning that women talk about,” Shapiro said.

“Because it’s so common, the idea of finding a vaccine is particularly appealing.”

Although men also contract UTIs, they are far more common among women and other people with vaginas, partly due to a shorter urethra, which makes it easier for bacteria to enter the urinary tract.

“Also varies around the time of our estrogen. If we have less estrogen, for example, in post-menopausal women, we’re more likely to see (UTIs) because of the change in the microbiome,” Shapiro said.

Between 50 and 60 per cent of women will develop more than one UTI in their lifetime, but as many as one in four women may also develop a recurrent urinary tract infection, defined as three or more UTIs in a 12-month period.

It is this condition that the new vaccine aims to tackle.

MV140 is a sublingual bacterial vaccine developed in Spain by Inmunotek, and has been approved for use there since 2010.

Since its development, it has been used for patients in several European countries through special access programs, including in the U.K., Sweden, Australia and New Zealand, among others.

Now, it is heading to Canada.

Red Leaf Medical, which owns the licence for Uromune (MV140) in Canada, filed a new drug submission with Health Canada a year ago.

Health Canada’s drug approval process can take one to two years.

“Uromune offers hope to women suffering from recurrent urinary tract infections who currently rely on multiple courses of antibiotics to treat their condition,” Charles Ko, managing director of Red Leaf Medical Inc., said in a press release at the time. “In addition to improving UTI management, Uromune has the potential to improve antibiotic stewardship and decrease the overall risk of antibiotic resistance.”

So will UTIs soon become a thing of the past?

Well, not with MV140 — the drug doesn’t provide full immunity against contracting a UTI, but does lessen the chances for those who have chronic infections. In a trial performed in Spain, described in a study published in 2022, the drug showed a 56 to 60 per cent efficacy in preventing UTIs in a nine-month study period.

A review published in the Canadian Urological Association Journal in 2020 found that Uromune had superior outcomes over other sublingual vaccines for UTIs.

Shapiro explained that this new drug doesn’t align with the typical concept of a vaccine as one or two shots that convey a lasting immunity.

It’s a sublingual vaccine, a type of vaccine which doesn’t use needles, but enters the body through tablets taken orally, or through a spray. 

“They’re made of inactivated bacteria, and the notion is that if you put (a tablet-based sublingual vaccine) under your tongue and it was daily for three months, your body would recognize these dead bacteria, mount an immune response at the level of where it should be … so that when you had an infection, you would mount your own immune response, not needing an antibiotic,” Shapiro said.

Uromune is a sublingual spray.

“It wouldn’t be a universal vaccine,” she said. “It’s something that would be used in women who are really having frequent urinary tract infections.”

For most of the population, a UTI is an uncomfortable experience that can be solved relatively quickly through antibiotics. But when a person has recurrent UTIs, the antibiotics start to become a problem.

“We worry about this because of antibiotic resistance, which we’re beginning to see, and many women end up being put on antibiotics on an ongoing basis if they have that criteria of ongoing chronic urinary tract infections,” Shapiro explained.

Antibiotic resistance occurs when bacteria learns how to fight against the antibiotics that have been developed in order to treat bacterial infections. The World Health Organization classifies it as “one of the biggest threats to global health” today, as a growing number of infections are becoming harder and harder to treat due to antibiotic resistance.

The stronger bacteria created by antibiotic resistance aren’t only a problem for the person who is being prescribed antibiotics that are no longer working — that stronger bacteria can also infect others and cause these more difficult infections to spread.

If Uromune is approved for use in Canada, it could help combat some of the antibiotic resistance that those with recurrent UTIs are at a risk of.