Pfizer and its partner, Valneva, have announced positive Phase II data from its trial of vaccine candidate VLA15 in a pediatric population. VLA15 is intended to prevent Lyme Disease (LD).
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Pfizer and its partner, Valneva, announced positive Phase II data from its trial of vaccine candidate VLA15 in a pediatric population. VLA15 is intended to prevent Lyme Disease (LD).
Lyme Disease is a vector-borne illness caused by the transmission of the bacteria Borrelia burgdorferi from ticks. Symptoms of LD can include a hallmark bullseye rash, fever, fatigue and joint and muscle pain which can be treated through an antibiotic regimen. However, if left untreated, the infection will continue to spread throughout the body causing central nervous system and cardiac complications that become difficult to treat or can cause permanent damage.
Pfizer and Valneva appear to be on track to provide a vaccine to prevent LD in pediatric populations. The company announced results from a Phase II trial which included 585 participants between the ages of five and 17-years-old. The trial evaluated the immunogenicity and safety of VLA15 after administration of a two or three-dose series.
The companies report that the vaccine produced a favorable immunogenic profile in participants dosed and was more effective at producing an immune response in the three-dose series. The vaccine also had a favorable safety and tolerability profile with no serious adverse events being reported.
“The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens. These positive pediatric data mark an important step forward in the ongoing development of VLA15, and we are excited to continue working with Valneva to potentially help protect both adults and children from Lyme disease,” Kathrin U. Jansen, Ph.D., senior vice president and head of vaccine research and development at Pfizer said in a press release.
Pfizer and Valneva reported positive Phase III data in February 2022 from their trial of VLA15 in adults. Results showed that the vaccine was efficient in producing antibodies against a surface protein of the LD bacterium, particularly in the three-dose series. The Phase III trial also supported an acceptable safety and tolerability profile.
The companies are on target to publish and present data from both clinical trials and are inching closer toward possible U.S. Food and Drug Administration approval. VLA15 was granted Fast Track Designation by the FDA and is currently the only LD vaccine candidate in clinical development. The companies are hopeful to provide a vaccine two decades after GlaxoSmithKline‘s LYMErix was pulled from the market in 2002 due to declining sales caused by unsupported fears of adverse side effects from the vaccine.
Although effective treatment exists for Lyme, the need for preventative treatment is high. Because some ticks can be extremely small and hard to see with the naked eye, some people may never know that they were bitten by a tick and need to seek testing for the disease. Additionally, many of the symptoms can be mistaken for other illnesses. Some patients may even go on to develop Post Treatment Lyme Disease Syndrome which the Centers for Disease Control and Prevention recognizes as a consequence of having LD but do not currently track or report on, making it difficult to ascertain the true impact of LD.
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