STATEN ISLAND, N.Y. — Vaccine makers Pfizer and Valneva SE announced the start of phase 3 clinical studies for their Lyme disease vaccine, the only immunization currently in development to combat the tick-borne disease.
The companies are planning to enroll around 6,000 people ages 5 and older in 50 sites where Lyme disease is endemic, including within the United States. The participants will receive either three doses of the vaccine, knows as VLA15, or a placebo and booster dose combination, said Pfizer in a release.
Data from previous studies showed high levels of vaccine effectiveness in both children and adults, said Pfizer. If phase 3 trials are successful, the companies can submit requests for approval in 2025.
“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,” said Dr. Annaliesa Anderson, senior vice president and head of Vaccine Research & Development at Pfizer. “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 Centers for Disease Control and Prevention (CDC) said it receives around 30,000 cases of Lyme disease annually; however, the actual extent of the disease is estimated to affect closer to 500,000 people in the United States every year.
Research published in June indicated Lyme disease has affected nearly 15% of the world’s population.
The disease is spread through the bite of blacklegged ticks, otherwise known as deer ticks, and often manifests in the form of a fever, headache, fatigue and a skin rash.
“We are extremely pleased to reach this important milestone in the development of VLA15,” said Dr. Juan Carlos Jaramillo, chief medical officer of Valneva. “Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere.”
The city Department of Health earlier this summer issued stark warnings to city residents to protect themselves against tick-borne diseases, including Lyme disease, which affected more than 800 people in New York City last year alone.
Staten Islanders are exposed to a wider range of tick populations than those in other boroughs, leaving them vulnerable to other disease. The borough is home to disease-carrying lone-star Asian longhorned and Gulf Coast ticks.
Residents should use an Environmental Protection Agency-registered insect repellent that contains DEET, picaridin, or IR3535 with a product label indicating it is effective against ticks (not mosquitos only) to mitigate the risk of Lyme disease.
Those who do venture into areas where ticks may be active should check for ticks on their bodies and clothing, along with their pets. Ticks are typically small — about the size of an apple seed when they’re fully developed — so seek help to inspect areas not easily reachable.
Using hot water when washing clothing kills ticks, said officials, but if hot water cannot be used, tumble dry, wet or damp clothes on low heat for 70 minutes or high heat for 40 minutes.
