As evidence grows that the disease spreads quickly across the US and Europe thanks to ticks, Pfizer (NSE:PFIZER) and its French partner Valneva (EPA:VLA) have started a late-stage study of a Lyme disease vaccine.
To conduct the phase 3 study of the jointly created vaccine, the only Lyme disease vaccine being tested on humans, the companies announced on Monday that they were seeking to enroll 6,000 adults aged five and older.
Lyme Disease
According to a Centers for Disease Control and Prevention review of insurance claims published last year, about 500,000 people each year in the US, where Lyme disease was initially identified in 1975, are diagnosed and treated for the condition.
A bacterium called Borrelia burgdorferi, which causes Lyme disease is spread to people via the bite of infected deer ticks. In its early stages, it often results in a red rash and fever, but if neglected, the condition can lead to significant complications like arthritis, heart issues, and brain inflammation.
Following a tripling of reported tick-borne illnesses in the US between 2004 and 2016, most of which were Lyme disease, US health officials said new methods for avoiding tick-borne infections are “urgently needed.”
According to a review of the literature published in June in the BMJ Global Journal, the presence of antibodies in blood indicates that more than 14% of the world’s population currently has or has had Lyme disease. The study by Chinese researchers found that men over 50 who reside in rural regions are more in danger.
According to senior research scientist Peter Krause of the Yale School of Public Health, the spread of tick-carrying wild deer across North America is assumed to be the primary cause of the disease’s rising prevalence. However, he warned, global warming may be contributing to the bacteria’s spread by fostering climatic conditions that ticks prefer.
Pfizer (NSE:PFIZER) and Valneva (EPA:VLA) are hoping to capitalize on the public’s anxiety about Lyme disease among those who engage in outdoor activities to make money from a vaccine. The vaccination would be given as a three-dose initial regimen and a booster shot afterward.
A former GSK Lyme disease vaccine was taken off the market in 2002 after some patients filed lawsuits alleging that it had adverse effects like the onset of arthritis. GSK refuted the allegations but discontinued the vaccine due to a weak market response.
The Lyme disease vaccine continues to exhibit high immunological responses among participants and acceptable safety and tolerability profiles in both adults and children, according to findings from Pfizer’s phase 2 research. According to the report, both businesses might submit applications for regulatory clearance of the vaccine in the US and Europe in 2025, depending on the outcomes of the phase 3 trial.
In light of the increased prevalence of Lyme disease worldwide, according to Annaliesa Anderson, head of Pfizer’s vaccine research and development, it is more crucial than ever to give people new options for protecting themselves.
Pfizer (NSE:PFIZER) and Valneva (EPA:VLA) are both working to create a vaccine for Lyme disease, and Pfizer (NSE:PFIZER) announced in June that it would pay €90.5 million to buy an 8% interest in Valneva (EPA:VLA). At the start of phase 3 clinical investigation, Pfizer (NSE:PFIZER) said it would pay Valneva (EPA:VLA) a $25 million milestone.
Featured Image: Megapixl @Motorolka
