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Johnson & Johnson Halts Late-stage E.coli Vaccine Trial After Poor Results

Pharmaceutical giants Johnson & Johnson and Sanofi have stopped a late-stage clinical trial for their experimental E.Coli vaccine after results failed to demonstrate sufficient efficacy.

The companies announced on Thursday that while the vaccine showed no safety concerns, it did not meet the necessary effectiveness thresholds to continue development.

The experimental vaccine, known as ExPEC9V, was designed to protect against bloodstream infections and sepsis caused by E.Coli bacteria, a major contributor to urinary tract infections and other serious health complications.

Pharmaceutical giants Johnson & Johnson and Sanofi have stopped a late-stage clinical trial for their experimental E.Coli vaccine. SOPA Images/LightRocket via Getty Images

The trial, which began in June 2021, recruited older adults aged 60 and above who had a recent history of urinary tract infections and were otherwise in stable health.

It was conducted across more than 250 sites spanning five continents.

Despite rigorous testing and monitoring, the vaccine did not produce the desired immune response to move forward.

J&J confirmed that an independent review of the data found no safety issues, and the company is now conducting follow-ups with participants who had already received the vaccine.

Shares of J&J were unchanged in pre-market trading on Thursday.

Sanofi, which partnered with J&J's Janssen unit in the development of the vaccine, disclosed that it had recorded a $250 million charge related to the halted trial in its fourth-quarter earnings report.

The experimental vaccine, known as ExPEC9V, was designed to protect against bloodstream infections and sepsis caused by E.Coli bacteria. Getty Images

However, the company reassured investors that the financial setback would not affect its 2025 revenue forecast, which was issued in January.

Jean-François Toussaint, head of vaccine research and development at Sanofi, stated that the companies would analyze the trial results to understand why the vaccine failed to achieve its intended efficacy.

"We will share further insights once we complete a comprehensive review of the data," he added.

The failure of ExPEC9V represents a setback in the ongoing battle against E.Coli infections, which pose significant public health risks.

While most strains of the bacteria are harmless and commonly found in the intestines of humans and animals, some can cause severe illnesses.

The more dangerous strains of E.Coli can lead to foodborne outbreaks, resulting in symptoms such as diarrhea, abdominal cramps, and, in severe cases, kidney failure.

Despite rigorous testing and monitoring, the vaccine did not produce the desired immune response to move forward. Getty Images

One recent example of the risks posed by E.Coli occurred last year when an outbreak linked to McDonald's Quarter Pounder hamburgers sickened 104 people and hospitalized 34.

That outbreak was caused by the O157:H7 strain, which is known for producing a dangerous toxin that can lead to severe complications.

The setback in vaccine development underscores the challenges scientists face in creating effective immunizations against bacterial infections.

Unlike viral diseases, which often have more predictable immune responses, bacterial infections can be more complex, requiring a deeper understanding of how to stimulate long-lasting immunity.

While the discontinuation of the ExPEC9V trial is a disappointment, experts believe the insights gained from this study could inform future vaccine development efforts.

Both J&J and Sanofi said they remain committed to advancing research in infectious disease prevention and will continue to explore alternative solutions to combat E.Coli-related illnesses.

For now, healthcare professionals emphasize the importance of preventive measures, including proper food handling, hygiene, and early treatment of urinary tract infections, to reduce the risks associated with E.Coli infections.


Top 6 Foods To Avoid That Can Cause Food Poisoning

Food poisoning is a result of the ingestion of contaminated food or drinks and is an uncomfortable position to be in. If you didn't know already, bacteria, viruses, parasites, and toxins are typical offenders when it comes to foodborne sickness. Although handling and preparation techniques can go a long way towards preventing risks, some foods present higher risks for harbouring poisonous pathogens.

In an exclusive interaction with the editorial team of Onlymyhealth, our expert, Pooja Singh, Dietician, ShardaCare, Health City - Noida, shared of list of six foods you should handle with care to avoid food poisoning. Here is what she shared with us.

1. Raw or Undercooked Poultry and Meat

Raw or undercooked poultry and meat may contain the dangerous bacteria Salmonella, E. Coli, and Listeria. They can induce very serious cases of food poisoning whose symptoms extend from stomach pain to life-threatening conditions. Expert Pooja recommended that it is always necessary to cook meat and poultry to the suggested internal temperatures: poultry to 165°F (74°C), and ground meats to 160°F (71°C).

2. Raw or Undercooked Seafood

Seafood such as raw oysters, clams, and sushi may contain bacteria and viruses such as Vibrio, Norovirus, and Hepatitis A. Raw or undercooked seafood can pose a higher risk of foodborne illness, especially for those with compromised immune systems. Make sure seafood is cooked thoroughly to reduce the risk.

Also Read: When Is The Right Time To Lift Weight For Women? Find Out Here

3. Unpasteurised Dairy Products

Unpasteurised (raw) milk, cheese, and other dairy products may contain harmful bacteria like Listeria, E. Coli, and Salmonella. Pasteurisation is a method that kills harmful microbes, thereby making dairy products safe for consumption. Therefore, choose pasteurised dairy products to lower your infection risk.

4. Raw Sprouts

Alfalfa, beans, and other raw sprouts are at risk of being contaminated with bacteria since they are grown in warm, moist conditions that are most favourable for Salmonella and E. Coli. It is better to cook the sprouts before consumption, particularly for children, the elderly, and immunocompromised individuals.

5. Pre-cut or Pre-packaged Vegetables and Fruits

Although handy, pre-cut vegetables and fruits are a habitat for bacteria caused by greater handling and exposure. If not sufficiently washed or handled at safe temperatures, these products may harbour Listeria and other pathogenic microbes. Minimise risk by washing produce in-depth and chilling it immediately.

Also Read: Antepartum Depression: How To Recognise The Signs In Pregnant Women

6. Raw or Undercooked Eggs

Raw or undercooked eggs may have Salmonella, a bacterium that causes most foodborne illnesses. Do not eat raw eggs in foods such as homemade mayonnaise, cookie dough, and hollandaise sauce. Scramble or fry eggs until the yolk and white are set to make them safe to eat.

Food poisoning prevention begins with being careful about what you eat and how it is prepared. Proper cooking, washing, and storage can help reduce risks and keep you healthy from dangerous foodborne diseases. When in doubt, choose thoroughly cooked and well-stored food to safeguard your health and well-being.


UKHSA Urges People To 'check In' Over Potentially 'life-threatening' Infection

Exclusive:

The UKHSA took to X to issue the warning earlier this week (

Image: Getty Images/iStockphoto)

The UK Health Security Agency (UKHSA) has issued an alert over a health issue which it said can be 'life-threatening'. The Government agency posted to X, urging people to check on individuals who might be more at risk of urinary tract infections (UTIs) - especially anyone over 65.

"UTIs are unpleasant for most but for some they can be life-threatening," it said in an update this week. "Check in on those who might be more at risk of developing UTIs, including those aged 65+. Know the signs."

UTIs are conditions affecting the urinary system, which encompasses the kidneys, urethra, and/or bladder. While these infections can strike anyone, they are notably more prevalent in females, with about half experiencing one at some point in life, according to Cleveland Clinic.

Although typically non-threatening, UTIs can escalate to sepsis, a serious condition where the body's infection-fighting response mistakenly turns against itself. In the worst cases, Dr Lawrence, a retired GP at the UK Care Guide, explained that septic shock can take place, which require urgent medical care. "I've seen in severe upper UTIs where the infection spreads to the bloodstream," he told the Mirror.

"In my experience, underlying conditions like diabetes or a weakened immune system can increase the risk of a UTI becoming life-threatening. So, it's critical for individuals with such conditions to seek medical advice promptly when symptoms arise."

It is important to note that UTIs are broadly separated into two categories - lower and upper UTIs. The first of these typically involves the bladder (cystitis) and urethra (urethritis), while upper UTIs generally affect the kidneys.

Usually, it is the upper UTIs that trigger more severe symptoms, requiring prompt medical attention. Dr Gareth Nye, lecturer of Biomedical Science at the University of Salford, also told the Mirror: "The most common causative bacteria is E coli which is responsible for up to 90 per cent of UTI infections.

"Most UTIs begin with bacteria infecting the urethra which is the tube urine comes through. This normally is due to a result of cross contamination with bacteria from the anus during trips to the toilet and is the main reason UTIs are common in children learning to wipe independently.

"As females have a naturally shorter urethras and it is in closer proximity to likely bacterial sources, they are much more likely to develop UTIs... UTIs can be life threatening, if they reach the kidneys the infection can cause permanent kidney damage which has whole body effects such as changes to blood pressure and lower ability to remove toxins from the body.

"UTIs in pregnancy can lead to premature births which has high risks for both mum and baby." In light of this, both doctors suggest it is always worth looking out for the common symptoms of UTIs and other signs that indicate they may have become more serious.

Although typically non-threatening, UTIs can escalate to sepsis in extreme cases (

Image:

Getty Images)

Needing to urinate more frequently and pain while going to the toilet are among the common signs you might expect, but others may seem completely unrelated. This especially includes a sudden onset of confusion or memory loss, which is sometimes brushed off among older individuals.

"Older people often have UTIs which present with non-standard symptoms," Dr Nye continued. "Older people which sudden onset confusion or memory problems may be suffering from a UTI, particularly if they already have an underlying brain condition.

"(But in general) the symptoms distinguish how far the infection has spread and which type of UTI you have. Urethritis causes burning sensation during urination or discharge but can often go unnoticed.

"Cystitis is when people often notice the infection as the symptoms include pain when urinating, increased urination frequency, pain in the lower abdomen and cloudy, bad smelling urine. Some women report feeling a pulling or dragging sensation when urinating.

"If the infection reaches the kidneys, it can be a very serious medical condition and symptoms include fever, vomiting and pain in the lower back." Similarly, Dr Cunningham added: "Sometimes, patients also report pelvic pain, especially in cases of cystitis.

"I've always advised my patients to be vigilant about these symptoms because early detection can prevent complications. In cases of upper UTIs, symptoms might also include fever, chills, and flank pain, indicating a need for immediate medical intervention."

Mild UTIs confined to the urethra usually go away without medical treatment, but both professionals recommend seeking a GP's advice in all cases to avoid further complications. Keeping hydrated and drinking plenty of water can also reduce the risk of infection, in addition to good personal hygiene and urinating after sexual intercourse.

"Yes, mild cases of UTIs might resolve without treatment, but this is not something I typically recommend relying on," Dr Lawrence said. "It's always safer to consult a GP to avoid complications.

"I always recommend seeking medical advice if symptoms persist for more than a couple of days or if you experience severe symptoms like fever and flank pain. Early treatment can prevent the infection from becoming more serious."

Meanwhile, Dr Nye added: "As soon as symptoms appear it is best to seek medical support, this is why the urine testing sticks can help in forming a diagnosis. However, UTIs can be missed on urine dipstick tests and may require a more advanced sample to confirm, particularly if the level of bacteria are low at the time. If you have symptoms make sure you are seeking treatment as soon as possible."






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