A Lyme disease vaccine may soon be available in the United States for the first time in 20 years, as pharmaceutical giant Pfizer starts late-stage clinical testing for a series of anti-tick disease shots.
The New York City-based company has begun enlisting 6,000 people and children aged five and older for the Phase 3 trial that will commence by the end of the year. The three-dose vaccine will be provided over the course of nine months, followed by a booster dosage 12 months later. Pfizer intends to submit an application for FDA approval in 2025.
This stage follows Pfizer’s February announcement of positive Phase 2 data for the VLA15 injection. In this study, the business determined that a three-dose regimen was the most effective against the infection.
A Lyme disease vaccine could return to the market in the United States at a crucial time. The disease’s incidence has skyrocketed in recent years. In rural areas, the number of cases of tick-borne disease increased by 250 percent between 2007 and 2021, according to a report published last week by FAIR Health. Experts warn that tick bites are increasing in frequency, particularly in locations where insects are not often found.
Dr. Annaliesa Anderson, head of vaccine research and development at Pfizer, said in a statement, “With the increasing global incidence of Lyme disease, giving a new alternative for patients to protect themselves against the disease is more critical than ever.”
We expect that the Phase 3 data will further corroborate the favorable evidence for VLA15 so far, and we look forward to partnering with research sites across the United States and Europe on this crucial trial.
The protein-based vaccine will finish enrolment for this final phase of trials by the end of 2022 at the earliest.
Pfizer teamed with the French business Valneva in April of 2020, just as the COVID-19 pandemic was beginning, to develop a vaccine.
In 2020, 600 individuals aged between five and sixty-five participated in Phase 2 trials. Both businesses have prioritized getting the vaccine available to youngsters.
If successful, VLA15 would be the only Lyme disease vaccine accessible in the United States, although it would not be the first vaccine to reach the U.S. market.
In the late 1990s, British pharmaceutical company GlaxoSmithKline developed the very successful Lyme disease vaccine LYMErix. It was as efficient as 90% in avoiding infection.
It arrived about the same time as an anti-vaccine movement arose in the United Kingdom and across the globe due to incorrect reports that the measles, mumps, and rubella (MMR) vaccine caused autism in certain children.
This resulted in tremendous anger against the UK maker for releasing a vaccine to combat a disease that many did not view as a big threat. In 2002, the product was ultimately removed from the market due to low demand.
Lyme disease is on the rise in the United States, providing the potential for a replacement for LYMErix.
Analysis by FAIR Health, owner of one of America’s largest claims databases, indicated a 357 percent increase in tick-borne disease-related applications in rural areas between 2007 and 2021.
There was also an increase in urban areas, where it grew by 65 percent within the same time frame.
Lyme disease is most prevalent in the Northeastern states of New Jersey, Vermont, Maine, Rhode Island, and Connecticut, as expected.
In May, Dr. Jon Oliver, an entomologist at the University of Minnesota, told DailyMail.com that millions of Americans get bitten by ticks each, but severe infections such as Lyme disease and Alpha-gal syndrome seldom transmit through tick bites.
Lyme disease, the most prevalent tick-borne disease that affects up to 35,000 people annually, is transmitted by rats. A tick that feeds on a rat may contract the disease and then transmit the bacterium that causes it to its next host.
Tick-borne diseases, however, cannot be transmitted between humans or to another organism, as humans are incapable of doing so.
These types of bacterial infections are also harmless to ticks, allowing them to continue feeding on other animals after becoming sick.
The majority of tick bites go unreported because ticks have evolved to feed on humans without their recognition, even releasing hormones that numb the host.
The insects can remain attached to a host for several hours; but, with each passing hour, the likelihood that they will transmit a potentially severe disease increases.
Oliver stated, “Most tick-borne infections require a tick to eat for at least 24 hours before transmitting the bacterial sickness.”
Within the first 24 hours of a tick attaching to a human, the chance of disease transfer is minimal, he explains. After 36 hours, the danger would have dramatically grown, and after 60 hours, the probability of transmission is practically 100 percent.
Even when a person does become infected, they commonly recover without medical treatment, and they may not even be aware that they were infected.
Oliver estimates that official statistics may only capture approximately ten percent of infections, with approximately 300,000 people afflicted annually.
Because only about one percent of tick bites result in an infection, millions of individuals are unknowingly bitten by the insects each year.
The prevalence of these organisms has also increased. As humans deforest and occupy natural environments, they interact with a greater number of insects than they would otherwise.
‘There are many more ticks than there were 20 years ago, and the spread of ticks has greatly grown,’ he said, indicating that Lyme disease and other ailments may be on the rise.
