News, Culture & Society

Pfizer starts late-stage clinical trials Lyme disease vaccine

A Lyme disease vaccine could soon hit the market in the U.S. for the first time in two decades, as pharma giant Pfizer enters late-stage clinical trials for a vaccine that prevents infection from the tick-borne illness.

The New York City-based firm is starting enrollment of 6,000 adults and children aged five an up for the Phase 3 trial that is set to begin by the end of the year. The three dose vaccine will be administered over nine months, and then participants will receive a booster 12 months later. Pfizer is aiming to apply for Food and Drug Administration approval in 2025.

This stage comes after Pfizer reported strong Phase 2 data for the shot – called VLA15 – in February. In that trial, the company determined that the three dose regimen was most effective against the virus.

A vaccine for Lyme disease could return to the market at a much needed time in the U.S. Cases of the disease have rocketed in recent years. An analysis published last week by FAIR Health found that cases of of the tick-borne illness have jumped 250 percent in rural areas from 2007 to 2021. Experts are warning that tick bites are becoming more frequent as well, especially in areas where the critters would not be expected.

Pfizer is launching Phase 3 clinical trials – the final trial – for a Lyme disease vaccine. It would be the first jab for the disease available since GSK’s shot was pulled from the market amid a budding anti-vaccine movement in 2002 (file photo)

Prevalence of Lyme disease has increased in recent years as bites from the blacklegged ticks that transmit it have jumped. Dr John Oliver partially blames deforestation for the increase in tick bites

Prevalence of Lyme disease has increased in recent years as bites from the blacklegged ticks that transmit it have jumped. Dr John Oliver partially blames deforestation for the increase in tick bites

‘With increasing global rates of Lyme disease, providing a new option for people 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 generated from the Phase 3 study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the U.S. and Europe on this important trial.’

The protein based vaccine will complete enrollment for this final stage of trials as early as the end of 2022.

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

Phase 2 trials were initiated 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 would be the only vaccine for Lyme disease available in America – but it would not be the first to ever hit the U.S. market.

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

Analysis by FAIR Health looked through more than 36 billion private healthcare claims filed across most of America's 50 states

Analysis by FAIR Health looked through more than 36 billion private healthcare claims filed across most of America’s 50 states

Lyme disease is, as expected, most common in the Northeastern region of the U.S.

Lyme disease is, as expected, most common in the Northeastern region of the U.S.

Its arrival came around the same time that an anti-vaccine movement erupted in the UK – and across 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 fraction of tick bites will actually result in a disease

Oliver (pictured), an entomologist at the University of Minnesota, says that only a fraction of tick bites will actually result in a disease

This led to significant backlash against the UK manufacturer for launching a jab to fight a disease many did not see as a major threat. There was little demand for it and it eventually was pulled off the market in 2002.

Lyme disease is starting to surge in the U.S., though, opening the door for another shot to take LYMErix’s place.

Analysis by FAIR Health — owner of one of America’s largest claims databases — revealed a 357 percent surge in applications linked to the tick-borne illness from 2007 to 2021 across rural areas. 

There was also an uptick in towns and cities, where it rose 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 DailyMail.com in May that millions of Americans are bit by ticks every year, but transmission of dangerous diseases related to tick bites like Lyme disease and Alpha-gal syndrome rarely transmit.

Shania Twain says Lyme disease battle was ‘devastating’ as it involved open-throat surgery 

Shania Twain says her Lyme disease battle was ‘devastating’.

The Man! I Feel Like a Woman! hitmaker contracted the tick-borne illness 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 ‘mourned’ the loss of her voice, because she thought her disease would mean she’d never be able to sing again.

‘It was devastating… I felt I had no other choice but to just accept it – in that I would never sing again. I was mourning the expression of my voice,’ said the star.

After taking some time away from the spotlight to recover, Shania made her music comeback in 2017, complete with a new gravelly tone to her voice, which she now believes is ‘kinda sexy’. 

Speaking to Sunday Today, she added: ‘I’m never going to have my old voice again. I’m okay with that. I’ve found a new voice and I like it. [It’s] kinda sexy.’

Shania Twain says her Lyme disease battle was 'devastating'. She contracted the tick-borne illness in 2003, and was forced to undergo open-throat surgery after her voice was damaged

Shania Twain says her Lyme disease battle was ‘devastating’. She contracted the tick-borne illness 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 off of a rat may acquire the disease, then pass the bacteria that causes it onto the next animal it feeds off of.

Tick-borne illnesses reach their dead-end with humans, though, as people can not transmit it to each other, or to another organism.

These type of bacterial infections also do no harm to the tick, allowing it to continue feeding off of other creatures even after it has become infected.

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

The bugs can stick to a person for a long time, though, with each passing hour they are attached to the host increasing the likelihood they pass on a potentially dangerous disease.

‘Most tick born diseases require a tick to feed for at least 24 hours before they transfer the bacterial disease,’ Oliver said.

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

Even when a person does get infected, they often manage to deal with it without medical treatment, and they may not even know they were suffering from the infection.

Oliver believes that official figures may only be catching around ten percent of cases – with around 300,000 people likely being infected every year.

With only around one percent of tick bites leading into an infection, this means that million of people are unknowingly getting chomped on by the critters on a yearly basis.

The prevalence of these creatures has increased as well. As humans destroy forests and invade natural habitats, they are also interacting with more bugs that they wouldn’t be otherwise.

‘There are far more ticks than there were 20 years ago, and the distribution of ticks has expanded a lot,’ he said, a harbinger for what may be to come with Lyme disease and other illnesses.

***
Read more at DailyMail.co.uk