A Lyme disease vaccine could soon hit the market in the United States for the first time in two decades, as pharmaceutical giant Pfizer enters early clinical trials for a vaccine that prevents infection from the tick-borne disease.
The New York-based company is starting to enroll 6,000 adults and children ages five and older for a Phase 3 trial that is scheduled to begin at the end of the year. The three-dose vaccine will be given over nine months, and then participants will receive a booster 12 months later. Pfizer aims to apply for Food and Drug Administration approval in 2025.
The move comes after Pfizer reported strong Phase 2 data for the lead — called VLA15 — in February. In the trial, the company determined that the three-dose regimen was the most effective against the virus.
A Lyme disease vaccine could be back on the market at a time when it is desperately needed in the U.S. Cases of the disease have been on the rise in recent years. An analysis published last week by the health organization FAIR Health found that cases of the tick-borne disease have increased by 250 percent in rural areas from 2007 to 2021. Experts warn that tick bites are also on the rise, especially in areas where criminals will not be expected.
Pfizer is launching a Phase 3 clinical trial — the final trial — of a Lyme disease vaccine. It would be the first setback for the disease since GSK’s shot was brought onto the market amid anti-vaccine protests in 2002 (file photo)
The prevalence of Lyme disease has increased in recent years with bites from the black-legged ticks that transmit it. Dr John Oliver partly blames deforestation for the increase in tick bites
“With increasing global rates of Lyme disease, providing people with new options to help protect themselves from the disease is more important than ever,” Dr. Annaliesa Anderson, head of vaccine research and development at Pfizer, said in a statement.
‘We hope that the data from the Phase 3 study will further support the positive evidence for VLA15 to date, and we look forward to collaborating with research sites across the US and Europe on this important trial.’
The protein-based vaccine will complete enrollment for this final phase of the trial as early as late 2022.
Pfizer partnered with the French company Valneva to work on the vaccine in April 2020 – while the COVID-19 pandemic was still ongoing.
Phase 2 trials began in 2020, including 600 people between the ages of five and 65. Both companies have put an emphasis on making the jab available to children as well.
If successful, VLA15 will be the only Lyme disease vaccine available in America — but it won’t be the first to hit the US market.
LYMErix was the most effective Lyme disease vaccine developed by the British pharmaceutical giant GlaxoSmithKline in the late 1990s. It was up to 90 percent effective in preventing infection.
The FAIR Health analysis examined more than 36 billion private health claims filed in most of America’s 50 states.
Lyme disease, as expected, is more common in the Northeast region of the United States
His arrival came at the same time as an anti-vaccination 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.
Oliver (pictured), an entomologist at the University of Minnesota, says that only a small proportion of tick bites will cause disease.
This caused a lot of backlash against the British manufacturer for launching a jab against a disease that many did not see as a serious threat. There was limited demand and it was finally released on 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 the largest claims database in the United States — revealed a 357 percent increase in tick-borne disease claims from 2007 to 2021 in rural areas.
There was also an increase in towns and cities, where it increased by 65 percent during the same period.
As expected, Lyme disease is 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 each year, but the transmission of serious diseases associated with tick bites such as Lyme disease and Alpha-gal disease is rarely distributed.
Shania Twain says her battle with Lyme disease was ‘horrendous’ as it involved open throat surgery
Shania Twain says her battle with Lyme disease was ‘horrendous’.
Man! I Feel Like A Woman! the hitmaker contracted the disease in 2003, and had to undergo throat surgery after his voice was destroyed by the effects of dysphonia due to the disease. And now, Shania has said she ‘mourned’ the loss of her voice, because she thought her illness would mean she would no longer be able to sing.
‘It was sad… I felt I had no choice but to just accept it – so I’m not going to sing anymore. I was mourning the expression of my voice,’ said the star.
After taking some time away from the spotlight to recuperate, Shania returned to her music in 2017, with a new upbeat sound, which she now believes is ‘kinda catchy’.
Speaking to Sunday Today, he added: ‘I will never have my old voice again. I’m fine with that. I found a new sound and I love it. [It’s] kinda sexy.’
Shania Twain says her battle with Lyme disease was ‘horrendous’. He contracted tick-borne disease in 2003, and had to undergo throat surgery after his voice was damaged.
Lyme disease, a tick-borne disease that affects up to 35,000 people each year, comes from rats. A tick that feeds on a mouse can contract the disease, then pass the bacteria that causes it to the next animal that eats it.
Tick-borne diseases are limited to humans, though, as people cannot transmit them to each other, or to another organism.
These types of bacterial infections also do not harm ticks, allowing them to continue feeding on other organisms even after infection.
Because ticks have evolved to feed on a person without them realizing it – even releasing chemicals that numb the host – the majority of tick bites go undetected.
Insects can stick to a person for a long time, although, every hour that passes they connect with the host and increase the possibility of passing a dangerous disease.
“Most tick-borne diseases require the tick to feed for at least 24 hours before it can transmit the bacterial disease,” Oliver said.
He explains that after the first 24 hours after a tick attaches itself to a human, the risk of disease transmission is low. After 36 hours, the risk would increase rapidly, and by 60 hours, there is a 100 percent chance of infection.
Even when a person is infected, they can often cope without treatment, and may not even know that they were suffering from an infection.
Oliver believes that the official figures may be around ten percent of cases – and around 300,000 people may be infected each year.
With only about one percent of tick bites resulting in infection, this means that millions of people are unknowingly suffocated by these insects each year.
The prevalence of these species has also increased. As humans destroy forests and invade natural habitats, they are also interacting with more insects that would otherwise not be there.
“There are more ticks than there were 20 years ago, and the distribution of ticks has increased dramatically,” he said, a precursor to what could come with Lyme disease and other diseases.
Source: | This article is originally from Dailymail.co.uk