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 vaccine that prevents infection by the tick-borne disease.
The New York City-based company is beginning enrollment of 6,000 adults and children ages 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, and participants will receive a booster shot 12 months later. Pfizer aims to seek approval from the Food and Drug Administration in 2025.
This phase comes after Pfizer reported strong Phase 2 data for the shot — dubbed VLA15 — in February. In this study, the company found that the three-dose regimen was the most effective against the virus.
A Lyme disease vaccine could return to the US market at a much-needed time. Cases of the disease have skyrocketed in recent years. An analysis released last week by FAIR Health found that cases of the tick-borne disease in rural areas rose 250 percent from 2007 to 2021. Experts warn that tick bites are also becoming more common, especially in areas where the creatures would not be expected to live.
Pfizer starts phase 3 clinical trials — the final trial — for a Lyme disease vaccine. It would be the first available stitch for the disease since GSK’s shot was withdrawn from the market in 2002 amid a burgeoning anti-vaccine movement (file photo).
The prevalence of Lyme disease has increased in recent years as the bites of the black-legged ticks that transmit it have skyrocketed. dr John Oliver partially blames deforestation for the increase in tick bites
“With rates of Lyme disease rising around the world, it’s more important than ever to offer people a new way to protect themselves from the disease,” said Dr. Annaliesa Anderson, Pfizer’s director of vaccine research and development, in a statement.
‘We hope that the data generated from the Phase 3 study will further support the positive evidence to date for VLA15, and we look forward to collaborating with research centers in the US and Europe on this important study.’
The protein-based vaccine will complete recruitment for this final phase of trials as early as late 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 studies began in 2020, involving 600 people between the ages of five and 65. Both companies have made it a priority to make vaccination accessible 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 US market.
LYMErix was a highly effective Lyme disease vaccine manufactured by British pharmaceutical giant GlaxoSmithKline in the late 1990s. It was up to 90 percent effective in preventing infection.
FAIR Health’s analysis searched more than 36 billion private health insurance claims filed in most of America’s 50 states
As expected, Lyme disease is most prevalent in the Northeast United States
His arrival came at around the same time as 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 actually result in disease
This prompted significant backlash against the British manufacturer for introducing a vaccine 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.
However, Lyme disease is starting to rise in the US, opening the door for another shot to take LYMErix’s place.
An analysis by FAIR Health — owners of one of America’s largest damage databases — found a 357 percent increase in claims related to the tick-borne disease from 2007 to 2021 in rural areas.
There was also an upward trend in the cities, where it increased by 65 percent over the same period.
As expected, Lyme disease is most common in northeastern states like New Jersey, Vermont, Maine, Rhode Island and Connecticut
dr Jon Oliver, an entomologist at the University of Minnesota, told in May that millions of Americans are bitten by ticks each year, but transmission of dangerous diseases linked to tick bites, such as Lyme disease and alpha gal syndrome, is rare is transferred.
Shania Twain says battle with Lyme disease was ‘devastating’ as it involved open throat surgery
Shania Twain says her battle with Lyme disease was ‘devastating’
The man! I feel like a woman! Hitmaker contracted the tick-borne disease in 2003 and had to undergo open throat surgery after her voice was damaged by the effects of dysphonia resulting from the disease. And now Shania has said she “mourned” 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 like I had no choice but to just accept it – to the point of never singing again. I mourned the expression in my voice,” the star said.
After spending some time away from the spotlight to recuperate, Shania made her music comeback in 2017, complete with a new husky tone to her voice that she now thinks is “kinda sexy”.
Speaking to Sunday Today, she added: “I’ll never have my old voice again. I agree. I found a new voice and I like it. [It’s] kind of sexy.’
Shania Twain says her battle with Lyme disease was ‘devastating’ She contracted the tick-borne disease in 2003 and had to undergo open throat surgery after her voice was damaged
Lyme disease, the most common tick-borne disease affecting up to 35,000 people annually, originated in rats. A tick that feeds on a rat can get the disease and then pass on the bacteria that causes it to the next animal it feeds on.
However, tick-borne diseases reach their dead end in humans because humans cannot transmit them to each other or to another organism.
This type of bacterial infection also does not harm the tick, so it can continue to feed on other living things even after infection.
Because ticks have evolved to feed on a person without them noticing — even releasing chemicals that stun the host — most tick bites go unnoticed.
However, the bugs can remain attached to a person for long periods of time, with each hour they attach to the host increasing the likelihood that they will transmit a potentially dangerous disease.
“Most tick-borne diseases require a tick to be fed for at least 24 hours before they transmit the bacterial disease,” Oliver said.
He explains that the risk of disease transmission within the first 24 hours after a tick has attached itself to a human is low. After 36 hours the risk would have increased rapidly, and after 60 hours there is practically a 100 percent chance of transmission.
Even when a person does become infected, they often manage to deal with it without medical treatment, and they may not even know they have the infection.
Oliver believes official figures may only capture around 10 percent of cases – with around 300,000 people expected to be infected each year.
With only about one percent of tick bites resulting in infection, this means millions of people are unknowingly eaten by the critters every year.
The prevalence of these creatures has also increased. As humans destroy forests and encroach on natural habitats, they also interact with more bugs than they otherwise would not.
“There are a lot more ticks than there were 20 years ago, and the spread of ticks has escalated a lot,” he said, a harbinger of what could be to come with Lyme disease and other diseases.