Pfizer and French pharmaceutical company Valneva are enlisting 6,000 people for a late-stage clinical trial that will test a vaccine designed to protect against the tick-borne Lyme disease, the drugmakers said Monday.
“With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important,” Annaliesa Anderson, the head of vaccine development at Pfizer, said in a news release.
Participants will include adults and children 5 and older. They will receive three doses of the vaccine candidate, known as VLA15, or a placebo, followed by one booster dose or another placebo. The study will be held in as many as 50 sites where Lyme disease is “highly endemic,” the drugmakers said, including Finland, Germany, the Netherlands, Poland, Sweden and the United States.
Pending successful completion of the trials, the companies said, they could submit the vaccine to regulators in the United States and Europe for approval in 2025.
Although traditionally more prevalent in New England, Lyme disease has been detected in all 50 states and D.C. About 476,000 people in the United States are treated annually for Lyme disease, according to the Centers for Disease Control and Prevention. Pop star Justin Bieber revealed in 2020 that he had been diagnosed with Lyme disease, and Canadian singer Avril Lavigne has also talked about her struggles with the disease and its complications.
Early symptoms include rashes, fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes.
Although Lyme disease can be treated effectively and rapidly with antibiotics, infections can result in permanent damage to joints or cause facial palsy, or drooping. In about 1 in every 100 cases, it can result in Lyme carditis, which occurs when Lyme disease bacteria enter the heart tissues. According to the CDC, 11 fatal cases of Lyme carditis were reported between 1985 and 2019.
Lyme disease is spread through blacklegged ticks, the CDC says. The insects attach to the human body, including hard-to-see areas such as the groin, armpits and the scalp. They then bite, injecting the bacteria responsible for Lyme disease. The insects must have attached to the body for 36 to 48 hours or more before the bacteria can be transmitted, the CDC says.
There is no evidence that Lyme disease can be transmitted through person-to-person contact or from pets to humans. However, pets can inadvertently bring ticks into yards or homes, the CDC says.