Pfizer has started the final phase of a clinical trial of a Lyme disease vaccine

A Lyme disease vaccine may soon reach the US market for the first time in two decades, as drug giant Pfizer is entering a late-stage clinical trial of a series of injections that prevent infection from the tick-borne disease.

The New York City-based company has begun enrolling 6,000 adults and children aged five and older in its Phase 3 beta, which is set to begin by the end of the year. The three-dose vaccine will be given over nine months, and then participants will receive a booster dose 12 months later. Pfizer aims to apply for FDA approval in 2025.

This phase comes after Pfizer reported strong data on the second phase of the shot – called VLA15 – in February. In that trial, the company determined that the three-dose regimen was more effective against the virus.

A Lyme disease vaccine could return to the market at a time when it is most needed in the United States. Cases of the disease have risen in recent years. An analysis published last week by FAIR Health found that cases of tick-borne disease jumped 250 percent in rural areas from 2007 to 2021. Experts warn that tick bites are becoming more frequent as well, especially in areas where these insects are present. not expected.

Pfizer is launching a phase 3 clinical trial — the final trial — for a Lyme disease vaccine.  This would be the first hit to the disease available since the GSK injection was pulled off the market amid the anti-vaccine movement in 2002 (file photo)

Pfizer is launching a phase 3 clinical trial — the final trial — for a Lyme disease vaccine. This would be the first hit to the disease available since the GSK injection was pulled off the market amid the anti-vaccine movement in 2002 (file photo)

The prevalence of Lyme disease has increased in recent years as the bites of the black tick that transmits the disease has jumped.  Dr. John Oliver partially blames deforestation for the increase in tick bites

The prevalence of Lyme disease has increased in recent years as the bites of the black tick that transmits the disease has jumped. Dr. John Oliver partially blames deforestation for the increase in tick bites

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

“We hope the data from the Phase 3 study will support the positive evidence for VLA15 so far, and we look forward to collaborating with research sites across the United States and Europe on this important trial.”

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

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

Phase 2 trials began in 2020, including 600 people between the ages of 5 and 65. Both companies focused on making the vaccine available to children as well.

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

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

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

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

Lyme disease is, as expected, more common in the northeastern region of the United States

Lyme disease is, as expected, more common in the northeastern region of the United States

His arrival came around the same time that the anti-vaccine movement erupted in the UK – and around the world – over false reports that the measles, mumps and rubella (MMR) vaccine was causing autism in some children.

Only a fraction of tick bites will actually cause disease, says Oliver (pictured), an entomologist at the University of Minnesota.

Only a fraction of tick bites will actually cause disease, says Oliver (pictured), an entomologist at the University of Minnesota.

This led to a major backlash against the UK manufacturer for launching a major blow to combat a disease that many did not see as a major threat. There was little demand for it and it was eventually withdrawn from the market in 2002.

Lyme disease is starting to rise in the United States, though, opening the door for another shot to replace LYMErix.

An analysis by FAIR Health – owner of one of America’s largest claims databases – revealed a 357 percent increase in applications associated with tick-borne diseases from 2007 to 2021 across rural areas.

There was also an uptick in towns and cities, up 65 percent over the same period.

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

Millions of Americans are bitten by ticks each year, but transmission of serious tick-related diseases such as Lyme disease and alpha-gal syndrome is rarely transmitted, Dr. John Oliver, an entomologist at the University of Minnesota, told DailyMail.com.

Shania Twain: The Lyme disease battle was ‘devastating’

Shania Twain says her battle against Lyme disease has been “devastating.”

the man! I feel like a woman! The hitmaker contracted the tick-borne disease in 2003, and was forced to undergo open-throat surgery after her voice was damaged by the effects of hoarseness as a result of the disease. Now, Shania said she was saddened by the loss of her voice, because she thought her illness would mean she would never be able to sing again.

“It was devastating…I felt I had no other choice but to accept that – because I would never sing again.” “I was saddened by the expression of my voice,” said the star.

After taking some time away from the spotlight to recover, Shania returned to her music in 2017, complete with a wonderful new tone in her voice, which she now thinks is “kinda sexy.”

Speaking to Sunday Today, she added, “I’ll never go back to my old voice again. I’m fine with that. I’ve found a new voice and I like it.” [It’s] rather sexy.

Shania Twain says her battle against Lyme disease has been “devastating.” She contracted the tick-borne disease in 2003 and was forced to have open-throat surgery after her voice was damaged.

Lyme disease, the most common tick-borne disease that affects up to 35,000 people each year, comes from mice. A tick that feeds on mice may become ill, and then transmit the bacteria that causes it to the next animal from which it feeds.

Tick-borne diseases come to a standstill with humans, as people cannot transmit them to each other or to another organism.

This type of bacterial infection also does not harm the tick, allowing it to continue feeding other organisms even after it has become infected.

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

Insects can stick to a person for a long time, however, with each passing hour they attach to the host, increasing the likelihood of transmitting a potentially dangerous disease.

“Most tick-borne diseases require that ticks have been feeding for at least 24 hours before they transmit bacterial disease,” Oliver said.

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

Even when a person does become infected, they can often manage it without medical treatment, and they may not even know they have the infection.

Oliver thinks the official numbers may only capture about ten percent of cases — with about 300,000 people likely to be infected each year.

With only about one percent of tick bites resulting in an infection, this means that one million people are unknowingly bitten by the creatures on a yearly basis.

The spread of these creatures also increased. As humans destroy forests and invade natural habitats, they are also interacting with more insects that they would not otherwise have.

“There are much more ticks than there were 20 years ago, and the distribution of ticks has expanded a lot,” he said, a harbinger of what may come with Lyme disease and other diseases.

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