Tuesday 9 August 2022 05:55 PM Pfizer starts late-stage clinical trials Lyme disease vaccine trends now
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
'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
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
This led to significant backlash against the UK manufacturer for launching a jab to fight a disease many did not see as a
