A Lyme disease vaccine could soon hit the US market for the first time in two decades, as pharmaceutical giant Pfizer enters late-stage clinical trials for a series of vaccines that prevent infection from the transmitted disease. by ticks.
The New York-based company is beginning to enroll 6,000 adults and children aged five and older for the Phase 3 trial which is expected to begin by the end of the year. The three-dose vaccine will be given over nine months, then participants will receive a booster 12 months later. Pfizer aims to seek Food and Drug Administration approval in 2025.
This milestone comes after Pfizer reported strong phase 2 data for the shot – called VLA15 – in February. In this trial, the company determined that the three-dose regimen was the most effective against the virus.
A Lyme disease vaccine could return to the market at a much-needed time in the United States. Cases of the disease have exploded in recent years. An analysis published last week by FAIR Health found that cases of tick-borne diseases jumped 250% in rural areas from 2007 to 2021. Experts warn that tick bites are also becoming more common, especially in areas where creatures would not be expected.
Pfizer is launching phase 3 clinical trials – the final trial – for a Lyme disease vaccine. It would be the first blow for the disease available since GSK’s vaccine was pulled from the market amid a nascent anti-vaccine movement in 2002 (file photo)
The prevalence of Lyme disease has increased in recent years, as bites from blacklegged ticks that transmit it have surged. Dr John Oliver partly blames deforestation for rise in tick bites
“With rising 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, in a press release.
“We hope the data generated from the Phase 3 study will further support the positive evidence for VLA15 to date, and we look forward to collaborating with research sites in the US and Europe on this important trial.”
The protein-based vaccine will complete recruitment for this final stage of trials as early as the end of 2022.
Pfizer partnered with French company Valneva to work on the vaccine in April 2020 – just as the COVID-19 pandemic was beginning.
Phase 2 trials were launched in 2020, including 600 people aged 5 to 65. Both companies have focused on making the jab available to children as well.
If successful, VLA15 would be the only Lyme disease vaccine available in America – but it wouldn’t be the first to hit the US market.
LYMErix was a highly effective Lyme disease vaccine made by British pharmaceutical giant GlaxoSmithKline in the late 1990s. It was up to 90 percent effective at preventing infection.
FAIR Health’s analysis looked at more than 36 billion private healthcare claims filed in most of the 50 U.S. states
Lyme disease is, as expected, most common in the northeastern region of the United States
Its arrival came around the same time an anti-vaccine movement erupted in the UK – and around the world – over false reports that the measles, mumps and rubella (MMR) vaccine caused 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
It led to a major backlash against the British manufacturer for launching a swipe to tackle a disease that many didn’t see as a major threat. There was little demand and it was finally taken off the market in 2002.
Lyme disease is beginning to rise in the United States, however, opening the door for another vaccine to take the place of LYMErix.
Analysis by FAIR Health – owner of one of America’s largest claims databases – found a 357% increase in tick-borne disease claims from 2007 to 2021 in rural areas.
There was also a slight uptick in towns and cities, where it increased by 65% over the same period.
As expected, Lyme disease is more common in northeastern states like 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 every year, but the transmission of dangerous diseases linked to tick bites like Lyme and Alpha-gal syndrome is rarely transmitted.
Shania Twain says battle with Lyme disease has been ‘devastating’
Shania Twain says her battle with Lyme disease has been “devastating”.
The man! I feel like a woman! 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 dysphonia as a result of the disease. And now Shania has said she is “mourning” the loss of her voice, as she believes her illness will mean she will never be able to sing again.
‘It was devastating… I felt I had no choice but to accept it – in that I would never sing again. I cried the expression in my voice,” the star said.
After taking some time away from the spotlight to recuperate, Shania made her musical comeback in 2017, with a new gritty tone to her voice, which she now considers “kinda sexy”.
Speaking to Sunday Today, she added: ‘I will never have my old voice again. I agree with that. I found a new voice and I love it. [It’s] kinda sexy.’
Shania Twain says her battle with Lyme disease has been “devastating”. She contracted the tick-borne disease in 2003 and was forced to undergo open-throat surgery after her voice was damaged.
Lyme disease, the most common tick-borne illness that affects up to 35,000 people every year, comes from rats. A tick that feeds on a rat can contract the disease and then transmit the bacteria that causes it to the next animal it feeds on.
However, tick-borne diseases reach their impasse in humans, as people cannot transmit them to each other or to another organism.
These types of bacterial infections also do no harm to 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 — the majority of tick bites go unnoticed.
Insects can stick to a person for a long time, however, with each passing hour they become attached to the host, which increases the likelihood that they will 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 after the first 24 hours after a tick attaches to a human, the risk of disease transmission is low. After 36 hours the risk would have increased rapidly and at 60 hours there is almost a 100% chance of transmission.
Even when a person is infected, they often manage to cope without medical treatment and may not even know they had the infection.
Oliver believes official figures can only detect around 10% of cases – with around 300,000 people likely to be infected each year.
With only about one percent of tick bites resulting in infection, that means millions of people are unknowingly eaten away 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 than they otherwise would.
“There are a lot more ticks than 20 years ago, and the distribution of ticks has widened a lot,” he said, a harbinger of what could happen with Lyme disease. and other diseases.
Pfizer launches late-stage Lyme disease vaccine clinical trials