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Pfizer initiates late-stage Lyme disease vaccine clinical trials

A vaccine against Lyme disease could soon hit the US market for the first time in two decades as pharmaceutical giant Pfizer starts late-stage clinical trials for a series of injections that prevent infection from the tick-borne disease.

The New York City-based company is beginning to enroll 6,000 adults and children ages five and older for the Phase 3 study, which begins by the end of the year. The three-dose vaccine is administered for nine months, and then participants are given a booster 12 months later. Pfizer aims to seek Food and Drug Administration approval by 2025.

This phase comes after Pfizer reported strong Phase 2 data for the uptake — dubbed VLA15 — in February. In that trial, the company determined that the three-dose regimen was most effective against the virus.

A vaccine against Lyme disease could hit the US market at a much-needed time. The number of cases of the disease has exploded in recent years. An analysis published last week by FAIR Health found that cases of tick-borne diseases increased by 250 percent in rural areas between 2007 and 2021. Experts warn that tick bites are also becoming more common, especially in areas where the bugs aren’t expected.

Pfizer launches Phase 3 clinical trials - its latest trial - for a vaccine against Lyme disease.  It would be the first shot against the disease available since GSK's shot was taken off the market amid a burgeoning anti-vaccination movement in 2002 (file photo)

Pfizer launches Phase 3 clinical trials – its latest trial – for a vaccine against Lyme disease. It would be the first shot against the disease available since GSK’s shot was taken off the market amid a burgeoning anti-vaccination movement in 2002 (file photo)

The prevalence of Lyme disease has increased in recent years as the bites of the black-legged ticks that transmit the disease have jumped.  dr.  John Oliver partially blames deforestation for tick bite increase

The prevalence of Lyme disease has increased in recent years as the bites of the black-legged ticks that transmit the disease have jumped.  dr.  John Oliver partially blames deforestation for tick bite increase

The prevalence of Lyme disease has increased in recent years as the bites of the black-legged ticks that transmit the disease have jumped. dr. John Oliver partially blames deforestation for tick bite increase

“With the increasing global rates of Lyme disease, it is more important than ever to provide people with a new option to protect themselves against the disease,” said Dr. Annaliesa Anderson, head of vaccine research and development at Pfizer, said in a statement.

“We hope the data generated from the Phase 3 trial will further support the positive evidence for VLA15 thus far, and we look forward to working with the US and European research sites on this important trial.”

The protein-based vaccine will complete enrollment for this final phase of trials as early as the end of 2022.

Pfizer teamed up with French company Valneva to work on the vaccine in April 2020 — just as the COVID-19 pandemic was getting underway.

Phase 2 studies will start in 2020, involving 600 people between the ages of five and 65. Both companies have emphasized making the shot available to children.

If successful, VLA15 would be the only Lyme disease vaccine available in America — but it wouldn’t be the first to ever hit the U.S. market.

LYMErix was a highly effective vaccine against Lyme disease manufactured in the late 1990s by British pharmaceutical giant GlaxoSmithKline. It was up to 90 percent effective in preventing infection.

Analysis by FAIR Health reviewed more than 36 billion private health claims filed in most of the 50 US states

Analysis by FAIR Health reviewed more than 36 billion private health claims filed in most of the 50 US states

Analysis by FAIR Health reviewed more than 36 billion private health claims filed in most of the 50 US states

Lyme disease, as expected, is most common in the northeastern region of the US

Lyme disease, as expected, is most common in the northeastern region of the US

Lyme disease, as expected, is most common in the northeastern region of the US

Its arrival came around the same time that an anti-vaccination movement was breaking out in the UK – and around the world – following false reports that the measles, mumps and rubella vaccine (MMR) was causing autism in some children.

Oliver (pictured), an entomologist at the University of Minnesota, says only a fraction of tick bites will actually lead to disease

Oliver (pictured), an entomologist at the University of Minnesota, says only a fraction of tick bites will actually lead to disease

Oliver (pictured), an entomologist at the University of Minnesota, says only a fraction of tick bites will actually lead to disease

This led to significant backlash against the British manufacturer for launching a jab to fight a disease that many did not see as a major threat. It was in low demand and it was eventually withdrawn from the market in 2002.

However, Lyme disease is starting to increase in the US, opening the door for another injection to take the place of LYMErix.

Analysis by FAIR Health – owner of one of America’s largest claims databases – revealed a 357 percent increase in claims related to the tick-borne disease from 2007 to 2021 in rural areas.

There was also an increase in cities, where it rose 65 percent over the same period.

As expected, Lyme disease is most common in northeastern states such as New Jersey, Vermont, Maine, Rhode Island, and Connecticut

dr. Jon Oliver, an entomologist at the University of Minnesota, told DailyMail.com in May that millions of Americans are bitten by ticks each year, but transmit dangerous diseases associated with tick bites, such as Lyme disease and alpha-gal syndrome. is rarely transmitted.

Shania Twain says battle with Lyme disease was ‘devastating’ because it involved open-throat surgery

Shania Twain says her battle with Lyme disease has been ‘devastating’.

The man! I feel like a woman! hitmaker contracted the tick-borne illness in 2003 and was forced to undergo open throat surgery after her voice was damaged from the effects of dysphonia resulting from the disease. And now Shania has said she “mourned” the loss of her voice, thinking her illness would mean she would never be able to sing again.

“It was devastating… I felt like I had no choice but to just accept it – in the sense that I would never sing again. I mourned the expression of my voice,” the star said.

After being away from the limelight for a while to recover, Shania made her musical comeback in 2017, complete with a new grindy tone in her voice, which she now finds “little sexy.”

Speak with Sunday Today, she added: ‘I will never have my old voice again. I’m okay with that. I found a new voice and I like it. [It’s] quite sexy.’

Shania Twain says her battle with Lyme disease has been 'devastating'.  She contracted the tick-borne illness in 2003 and was forced to undergo open throat surgery after her voice was damaged

Shania Twain says her battle with Lyme disease has been 'devastating'.  She contracted the tick-borne illness in 2003 and was forced to undergo open throat surgery after her voice was damaged

Shania Twain says her battle with Lyme disease has been ‘devastating’. She contracted the tick-borne illness in 2003 and was forced to undergo open throat surgery after her voice was damaged

Lyme disease, the most common tick-borne disease that affects up to 35,000 people annually, originates from rats. A tick that feeds on a rat can contract the disease and then pass the bacteria that cause the tick to the next animal it feeds on.

Tick-borne diseases reach their dead end in humans because humans cannot transmit it to each other or to another organism.

These types of bacterial infections also do not harm the tick, allowing it to continue feeding on other creatures even after becoming infected.

Because ticks have evolved to feed on a person without them noticing — even releasing chemicals that numb the host — most tick bites go undetected.

However, the critters can stick to a person for a long time, with each passing hour that they are attached to the host, they are more likely to transmit a potentially dangerous disease.

“Most tick-borne diseases require a tick to feed for at least 24 hours before transmitting the bacterial disease,” Oliver said.

He explains that within the first 24 hours after a tick has attached itself to a human, the risk of disease transmission is low. After 36 hours, the risk would have increased rapidly, and by 60 hours, there is virtually a 100 percent chance of transmission.

Even when a person becomes infected, they often manage to cope without medical treatment, and they may not even know they were suffering from the infection.

Oliver believes official figures can only catch about ten percent of cases – with about 300,000 people likely to become infected each year.

With only about one percent of tick bites leading to infection, this means that millions of people are unknowingly eaten by the critters every year.

The prevalence of these creatures has also increased. As humans destroy forests and invade natural habitats, they also interact with more insects that they otherwise wouldn’t be.

“There are a lot more ticks than there were 20 years ago, and the spread of ticks has increased dramatically,” he said, foreshadowing what could come with Lyme disease and other diseases.

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